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Trial record 59 of 332 for:    DONEPEZIL

Observational Study Of Donepezil In Routine Clinical Practice

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00843115
Recruitment Status : Terminated (See Detailed Description.)
First Posted : February 13, 2009
Results First Posted : June 2, 2009
Last Update Posted : March 13, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Ecologic or Community;   Time Perspective: Prospective
Condition Alzheimer's Disease
Intervention Other: donepezil
Enrollment 370
Recruitment Details This was a non interventional study conducted at 62 sites in Canada.
Pre-assignment Details Subjects had a diagnosis of mild to moderate Alzheimer's Disease with or without other etiologies of dementia.
Arm/Group Title Donepezil
Hide Arm/Group Description As per physician prescription
Period Title: Overall Study
Started 370
Completed 304
Not Completed 66
Reason Not Completed
Death             4
Adverse Event             30
Lost to Follow-up             4
Withdrawal by Subject             17
Family wanted meds stopped             1
Family does not want continuation             1
Patient forgot to take meds             1
Does not meet entrance criteria             1
Physician Decision             1
Family discontinued meds             1
patient took for 2 days then stopped             1
patient never took the medication             1
hospitalized due to deterioration             1
week 12 not done             1
Syndrome De Glissement             1
Arm/Group Title Donepezil
Hide Arm/Group Description As per physician prescription
Overall Number of Baseline Participants 370
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 370 participants
80.1  (7.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 370 participants
Female
172
  46.5%
Male
198
  53.5%
1.Primary Outcome
Title All Subjects Improved/Stabilized or Worsened for Cognitive Activation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Hide Description Cognitive Activation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis.
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: participants
Improved or Stabilized 196
Worsened 36
Missing/Not Applicable 90
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Binomial test of proportions
Comments Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05
2.Primary Outcome
Title All Subjects Improved/Stabilized or Worsened for Attention in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Hide Description Attention symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline and Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Improved/Stabilized=4,5,6; Worsened=2,3.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) : All subjects who did not have a response for post baseline assessment were not included in analysis.
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: Participants
Improved or Stabilized 202
Worsened 31
Missing/Not Applicable 89
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Binomial test of proportions
Comments Holms multiplicity adjustment Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05
3.Primary Outcome
Title All Subjects Improved/Stabilized or Worsened for Repetitiveness in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Hide Description Repetitiveness symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: Participants
Improved or Stabilized 195
Worsened 32
Missing/Not Applicable 95
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Binomial test of proportions
Comments Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05
4.Primary Outcome
Title All Subjects Improved/Stabilized or Worsened for Remembering in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Hide Description Remembering symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded toCategories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: participants
Improved or Stabilized 231
Worsened 44
Missing/Not Applicable 47
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Binomial test of proportions
Comments Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05
5.Primary Outcome
Title All Subjects Improved/Stabilized or Worsened for Temporal Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Hide Description Temporal Orientation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: Participants
Improved or Stabilized 209
Worsened 39
Missing/Not Applicable 74
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Binomial test of proportions
Comments Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05
6.Primary Outcome
Title All Subjects Improved/Stabilized or Worsened for Asphasia in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Hide Description Asphasia symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded toCategories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: participants
Improved or Stabilized 190
Worsened 28
Missing/Not Applicable 104
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Binomial test of proportions
Comments Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05
7.Primary Outcome
Title All Subjects Improved/Stabilized or Worsened for Spatial Orientation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Hide Description Spatial Orientation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to categories: Improved/Stabilized=4,5,6; Worsened=2,3
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: participants
Improved or Stabilized 201
Worsened 25
Missing/Not Applicable 96
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Binomial test of proportions
Comments Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05
8.Primary Outcome
Title All Subjects Improved/Stabilized or Worsened for Judgment in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Hide Description Judgment symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: participants
Improved or Stabilized 206
Worsened 30
Missing/Not Applicable 86
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Binomial test of proportions
Comments Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05
9.Primary Outcome
Title All Subjects Improved/Stabilized or Worsened for Insight in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Hide Description Insight symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: participants
Improved or Stabilized 209
Worsened 34
Missing/Not Applicable 79
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Binomial test of proportions
Comments Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05
10.Primary Outcome
Title All Subjects Improved/Stabilized or Worsened for Leisure in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Hide Description Leisure symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: participants
Improved or Stabilized 205
Worsened 28
Missing/Not Applicable 89
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Binomial test of proportions
Comments Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05
11.Primary Outcome
Title All Subjects Improved/Stabilized or Worsened for Domestic Activities in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Hide Description Domestic Activities symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: participants
Improved or Stabilized 198
Worsened 23
Missing/Not Applicable 101
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Binomial test of proportions
Comments Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05
12.Primary Outcome
Title All Subjects Improved/Stabilized or Worsened for Hygiene in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Hide Description Hygiene symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: participants
Improved or Stabilized 168
Worsened 23
Missing/Not Applicable 131
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Binomial test of proportions
Comments Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05
13.Primary Outcome
Title All Subjects Improved/Stabilized or Worsened for Dressing in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Hide Description Dressing symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: participants
Improved or Stabilized 152
Worsened 23
Missing/Not Applicable 147
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Binomial test of proportions
Comments Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05
14.Primary Outcome
Title All Subjects Improved/Stabilized or Worsened for Telephoning in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Hide Description Telephoning symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: participants
Improved or Stabilized 190
Worsened 16
Missing/Not Applicable 116
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Binomial test of proportions
Comments Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05
15.Primary Outcome
Title All Subjects Improved/Stabilized or Worsened for Agitation in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Hide Description Agitation symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: participants
Improved or Stabilized 157
Worsened 23
Missing/Not Applicable 142
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Binomial test of proportions
Comments Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05
16.Primary Outcome
Title All Subjects Improved/Stabilized or Worsened for Mood in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Hide Description Mood symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: participants
Improved or Stabilized 187
Worsened 38
Missing/Not Applicable 97
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Binomial test of proportions
Comments Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05
17.Primary Outcome
Title All Subjects Improved/Stabilized or Worsened for Anxiety in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Hide Description Anxiety symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: participants
Improved or Stabilized 195
Worsened 37
Missing/Not Applicable 90
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Binomial test of proportions
Comments Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05
18.Primary Outcome
Title All Subjects Improved/Stabilized or Worsened for Delusions in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Hide Description Delusions symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: participants
Improved or Stabilized 139
Worsened 16
Missing/Not Applicable 167
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Binomial test of proportions
Comments Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05
19.Primary Outcome
Title All Subjects Improved/Stabilized or Worsened for Apathy in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Hide Description Apathy symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: participants
Improved or Stabilized 187
Worsened 27
Missing/Not Applicable 108
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Binomial test of proportions
Comments Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate @ 0.05
20.Primary Outcome
Title All Subjects Improved/Stabilized or Worsened for Caregiver in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Hide Description Caregiver symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: participants
Improved or Stabilized 213
Worsened 30
Missing/Not Applicable 79
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Binomial test of proportions
Comments Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05
21.Primary Outcome
Title All Subjects Improved/Stabilized or Worsened for Severity in Top Symptom Checklist (TOPS) Alzheimer's Disease Assessment
Hide Description Severity symptom in TOPS checklist: Number of subjects Improved/Stabilized or Worsened. TOPS Ratings compared at baseline & Week 12. No symptoms=1, Emergence of symptoms=2, Symptoms Increased=3, Stable=4, Symptoms decreased=5, Cessation of Symptoms=6. Ratings recoded to Categories: Improved/Stabilized=4,5,6; Worsened=2,3.
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: participants
Improved or Stabilized 233
Worsened 40
Missing/Not Applicable 49
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments null hypothesis: the proportion of subjects who improved or stabilized, among those who had the symptom at baseline, is less than or equal to 0.5; the alternative hypothesis: this proportion is greater than 0.5
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Binomial test of proportions
Comments Holms multiplicity adjustment (Stepdown Bonferroni) for statistical significance of each p-value, while controlling experiment wise error rate at 0.05
22.Secondary Outcome
Title Change From Baseline in Mini-Mental State Examination (MMSE) Total Scores at Week 12
Hide Description MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranges from 0 - 30, higher score indicates better cognitive state. Change: mean score at Week 12 minus mean score at baseline.
Time Frame baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): (n=288; number of subjects responding)
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Mean (Standard Deviation)
Unit of Measure: score on scale
1.1  (2.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments Change from baseline in total score at Week 12
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments One sample t-test, testing whether mean change from baseline is significantly different from zero.
23.Secondary Outcome
Title Last Observation Carried Forward (LOCF) Change From Baseline in Mini-Mental State Examination (MMSE) Total Scores at Week 12
Hide Description MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranges from 0 - 30, higher score indicates better cognitive state. Change: mean score at Week 12 minus mean score at baseline
Time Frame baseline, Week 12 LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) LOCF: (n=318; number of subjects responding)
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Mean (Standard Deviation)
Unit of Measure: score on scale
1.1  (2.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments Change from baseline in total score at Week 12 Last Observation Carried Forward
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments One sample t-test, testing whether mean change from baseline is significantly different from zero
24.Secondary Outcome
Title Correlation Between Change From Baseline in Mini-Mental State Examination (MMSE) Score and Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Score
Hide Description MMSE cognitive function: Total 0 - 30, higher score, better cognitive state. Hr QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole using scale: 1 (poor) - 4 (excellent), possible total 13 - 52. Separate ratings from both patient and caregiver.
Time Frame baseline, 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT); n=207 (number of subjects who responded)
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: Pearson Product Correlation Coefficient
0.33
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method correlation coefficient
Comments P value tests whether Pearson Product Correlation Coefficient is significantly different from zero
25.Secondary Outcome
Title Correlation Between LOCF Change From Baseline in Mini-Mental State Examination (MMSE) Score and LOCF Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Score
Hide Description MMSE cognitive function. Total 0 - 30, higher score, better cognitive state. Hr QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Separate ratings from both the patient and the caregiver
Time Frame baseline, Week 12 LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) LOCF: (n=231; number of subjects responding).
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: Pearson Product Correlation Coefficient
0.35
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method correlation coefficient
Comments p-value tests whether Pearson Product Correlation Coefficient is significantly different from zero
26.Secondary Outcome
Title Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Scores
Hide Description Hr QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Separate ratings from both the patient and the caregiver. Change: mean score at Week 12 minus mean score at baseline.
Time Frame baseline, 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT). (n= 207; number of subjects who responded)
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Mean (Standard Deviation)
Unit of Measure: score on scale
1.4  (3.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments One sample t-test, testing whether mean change from baseline is significantly different from zero.
27.Secondary Outcome
Title LOCF Change From Baseline in Combined Patient and Caregiver Health Related Quality of Life (Alzheimer's Disease) (HR QoL-AD) Questionnaire Total Scores
Hide Description Hr QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Separate ratings from both the patient and the caregiver. Change: mean score at Week 12 minus mean score at baseline.
Time Frame baseline, 12 Week LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT)LOCF: (n=231; number of subjects responding)
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Mean (Standard Deviation)
Unit of Measure: score on scale
1.4  (3.44)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments One sample t-test, testing whether mean change from baseline is significantly different from zero
28.Secondary Outcome
Title Correlation Analysis: Change From Baseline in Combined Patient and Caregiver Quality of Life in Alzheimer's Disease(QoL-AD) Questionnaire Total Score Versus Number of Treatment Emergent Adverse Events (TEAEs)
Hide Description QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Patient and the caregiver totals combined and correlated to number of treatment emergent adverse events.
Time Frame baseline, 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT). (n=207 number of subjects responding)
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: Pearson Product Correlation Coefficient
-0.13
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0713
Comments [Not Specified]
Method correlation coefficient
Comments [Not Specified]
29.Secondary Outcome
Title Correlation Analysis: LOCF Change From Baseline in Combined Patient and Caregiver Quality of Life in Alzheimer's Disease (QoL-AD) Questionnaire Total Score Versus the Number of Treatment Emergent Adverse Events (TEAEs)
Hide Description QoL- AD: physical health, energy, mood, living situation, memory, family, marriage, friends, chores, fun, money, self, and life as a whole. Likert scale, 1 (poor) - 4 (excellent), possible total 13 to 52. Ratings from patient and the caregiver combined and correlated with number of treatment emergent adverse events.
Time Frame baseline, 12 Weeks LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) LOCF: (n=231; number of patients responding)
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: Pearson Product Correlation Coefficient
-0.15
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0225
Comments [Not Specified]
Method Correlation coefficient
Comments [Not Specified]
30.Secondary Outcome
Title Change From Baseline Total Score in EuroQuality of Life-5 Domains (EQoL-5D)
Hide Description EQoL-5D: measures index of health and defines it in 5 Domains:mobility,self-care,usual activities, pain/discomfort, anxiety/depression. Each domain evaluated on 3-point scale yielding 243 potential combinations; converted to utility values ranging from -0.59(worst state) to 1 (perfect state). Change: Week 12 mean score minus baseline mean score
Time Frame baseline, 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) (n=290; number of subjects responding)
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Mean (Standard Deviation)
Unit of Measure: score on scale
0.015  (0.1071)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0152
Comments [Not Specified]
Method t-test, 2 sided
Comments One sample t-test, testing whether mean change from baseline is significantly different from zero.
31.Secondary Outcome
Title LOCF Change From Baseline Total Score in EuroQuality of Life-5 Domains (EQoL-5D)
Hide Description EQoL-5D: measures index of health & defines it in 5 Domains: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each evaluated on 3-point scale yielding 243 potential combinations converted to utility values ranging from -0.59(worst state) to 1 (perfect state). Change:Week 12 mean score minus baseline mean score
Time Frame baseline, 12 Weeks LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) LOCF: (n=321; number of subjects responding)
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Mean (Standard Deviation)
Unit of Measure: score on scale
0.013  (0.1053)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0229
Comments [Not Specified]
Method t-test, 2 sided
Comments One sample t-test, testing whether mean change from baseline is significantly different from zero
32.Secondary Outcome
Title Change From Baseline in Visual Analog Scale (VAS) of Subject's Overall Health Included in EuroQuality of Life-5 Domains (EQoL-5D)Questionnaire
Hide Description EuroQuality of Life-5 Domains (EQoL-5D)Questionnaire includes a visual analogue scale (VAS) of subject's overall health with 0 (worst state) to 100 (best state). Change: mean score at Week 12 minus mean score at baseline.
Time Frame baseline, 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): (n=286; number of subjects responding).
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Mean (Standard Deviation)
Unit of Measure: score on scale
3.7  (10.55)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments One sample t-test, testing whether mean change from baseline is significantly different from zero.
33.Secondary Outcome
Title LOCF Change From Baseline in Visual Analog Scale (VAS) of Subject's Overall Health Included in EuroQuality of Life-5 Domains (EQoL-5D) Questionnaire
Hide Description EuroQuality of Life-5 Domains (EQoL-5D) Questionnaire includes a visual analogue scale (VAS) of subject's overall health with 0 (worst state) to 100 (best state). Change: mean score at Week 12 minus mean score at baseline.
Time Frame baseline, 12 Weeks LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT)LOCF: (n=318; number of subjects responding).
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Mean (Standard Deviation)
Unit of Measure: score on scale
3.1  (10.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method t-test, 2 sided
Comments One sample t-test, testing whether mean change from baseline is significantly different from zero.
34.Secondary Outcome
Title Change From Baseline in Subject's Mobility at Week 12
Hide Description EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including mobility (no problem walking, some problems walking, confined to bed). Analysis of difference between the number of subjects with "any problem" and "no problem" at baseline versus at Week 12.
Time Frame baseline, 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: participants
Any Problem 129
No Problem 161
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7963
Comments [Not Specified]
Method McNemar
Comments McNemar's Test for paired proportions tested the difference between the proportion of subjects with "Any problem" at baseline versus Week 12.
35.Secondary Outcome
Title Change From Baseline in Subject's Mobility at Week 12 LOCF
Hide Description EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including mobility (no problem walking, some problems walking, confined to bed). Analysis of difference between the proportion of subjects with "any problem" at baseline versus Week 12 LOCF
Time Frame Week 12 LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) LOCF: All Subjects who did not have a response for post baseline assessment were not included in analysis
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: Participants
Any Problem 147
No Problem 174
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method McNemar
Comments McNemar's Test for paired proportions tested the difference between the proportion of subjects with "Any problem" at baseline versus Week 12 LOCF.
36.Secondary Outcome
Title Change From Baseline in Subject's Self-Care at Week 12
Hide Description EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including self-care (no problem, some problems, unable to wash or dress). Analysis of difference between the number of subjects with "any problem" and "no problem" at baseline versus at Week 12
Time Frame baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: participants
Any Problem 122
No Problem 168
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0719
Comments [Not Specified]
Method McNemar
Comments McNemar's Test for paired proportions tested the difference between the proportion of subjects with "Any problem" at baseline versus Week 12
37.Secondary Outcome
Title Change From Baseline in Subject's Self-Care at Week 12 LOCF
Hide Description EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including self-care (no problem, some problems, unable to wash or dress). Analysis of difference between the number of subjects with "any problem" and “no problem” at baseline versus at Week 12 LOCF.
Time Frame baseline, 12 Weeks LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: Participants
Any Problem 140
No Problem 181
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1779
Comments [Not Specified]
Method McNemar
Comments McNemar's Test for paired proportions tested the difference between the proportion of subjects with "Any problem" at baseline versus Week 12 LOCF.
38.Secondary Outcome
Title Change From Baseline in Subject's Usual Activities at Week 12
Hide Description EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including usual activities(no problem, some problem, unable to perform). Analysis of difference between the number of subjects with "any problem" and “no problem” at baseline versus at Week 12.
Time Frame baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: Participants
Any Problem 181
No Problem 109
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method McNemar
Comments McNemar's Test for paired proportions tested the difference between the proportion of subjects with "Any problem" at baseline versus Week 12
39.Secondary Outcome
Title Change From Baseline in Subject's Usual Activities at Week 12 LOCF
Hide Description EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including usual activities (no problem, some problem, unable to perform). Analysis of difference between the number of subjects with "any problem" and “no problem” at baseline versus at Week 12 LOCF
Time Frame baseline, 12 Weeks LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: Participants
Any Problem 203
No Problem 118
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8575
Comments [Not Specified]
Method McNemar
Comments McNemar's Test for paired proportions tested the difference between the proportion of subjects with "Any problem" at baseline versus Week 12 LOCF
40.Secondary Outcome
Title Change From Baseline in Subject's Pain/Discomfort at Week 12
Hide Description EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including discomfort(no pain, moderate pain, extreme pain). Analysis of difference between the number of subjects with "any problem" and “no problem” at baseline versus at Week 12.
Time Frame baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: Participants
Any Problem 147
No Problem 143
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method McNemar
Comments McNemar's Test for paired proportions tested the difference between the proportion of subjects with "Any problem" at baseline versus Week 12
41.Secondary Outcome
Title Change From Baseline in Subject's Pain/Discomfort at Week 12 LOCF
Hide Description EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including discomfort(no pain, moderate pain, extreme pain). Analysis of difference between the proportion of subjects with "any problem" at baseline versus Week 12 LOCF
Time Frame Week 12 LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT)LOCF: All Subjects who did not have a response for post baseline assessment were not included in analysis
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: Participants
Any Problem 162
No Problem 159
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0000
Comments [Not Specified]
Method McNemar
Comments McNemar's Test for paired proportions tested the difference between the proportion of subjects with "Any problem" at baseline versus Week 12 LOCF
42.Secondary Outcome
Title Change From Baseline in Subject's Anxiety/Depression at Week 12
Hide Description EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including anxiety/depression(none, moderate or extreme anxiety/depression). Analysis of difference between the number of subjects with "any problem" and “no problem” at baseline versus at Week 12.
Time Frame baseline, Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT): All Subjects who did not have a response for post baseline assessment were not included in analysis
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: Participants
Any Problem 158
No Problem 132
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0131
Comments [Not Specified]
Method McNemar
Comments McNemar's Test for paired proportions tested the difference between the proportion of subjects with "Any problem" at baseline versus Week 12
43.Secondary Outcome
Title Change From Baseline in Subject's Anxiety/Depression at Week 12 LOCF
Hide Description EuroQuality of Life-5 Domains: health related tool (not disease specific) measuring index of health & defines health in 5 Domains, including anxiety/depression (none, moderate or extreme anxiety/depression). Analysis of difference between the proportion of subjects with "any problem" and “no problem” at baseline versus at Week 12 LOCF
Time Frame baseline, Week 12 LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT)LOCF: All Subjects who did not have a response for post baseline assessment were not included in analysis
Arm/Group Title Donepezil
Hide Arm/Group Description:
As per physician prescription
Overall Number of Participants Analyzed 322
Measure Type: Number
Unit of Measure: Participants
Any Problem 179
No Problem 142
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Donepezil
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0078
Comments [Not Specified]
Method McNemar
Comments McNemar's Test for paired proportions tested the difference between the proportion of subjects with "Any problem" at baseline versus Week 12 LOCF
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Donepezil
Hide Arm/Group Description As per physician prescription
All-Cause Mortality
Donepezil
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Donepezil
Affected / at Risk (%)
Total   12 
Cardiac disorders   
Bradycardia  2  1/370 (0.27%) 
Gastrointestinal disorders   
Diverticulum  1  1/370 (0.27%) 
General disorders   
Death  1  4/370 (1.08%) 
Hepatobiliary disorders   
Cholecystitis  2  1/370 (0.27%) 
Infections and infestations   
Diverticulitis  1  1/370 (0.27%) 
Lobar Pneumonia  1  1/370 (0.27%) 
Pneumonia  2  1/370 (0.27%) 
Urinary Tract Infection  2  1/370 (0.27%) 
Urosepsis  2  1/370 (0.27%) 
Metabolism and nutrition disorders   
Hypercalcaemia  2  1/370 (0.27%) 
Hypoglycemia  2  1/370 (0.27%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Lung Neoplasm Maglinant  2  1/370 (0.27%) 
Nervous system disorders   
Cerebrovascular Accident  2  1/370 (0.27%) 
Syncope  2  1/370 (0.27%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA v11.1
2
Term from vocabulary, MedDRA v 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Donepezil
Affected / at Risk (%)
Total   54 
Gastrointestinal disorders   
Diarrhoea  1  13/370 (3.51%) 
Nausea  1  22/370 (5.95%) 
Vomiting  1  12/370 (3.24%) 
General disorders   
Asthenia  1  8/370 (2.16%) 
Nervous system disorders   
Headache  1  13/370 (3.51%) 
Psychiatric disorders   
Insomnia  1  9/370 (2.43%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA v 11.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc
Phone: 1-800-718-1021
EMail: ClinicalTrials.govCallCenter@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00843115     History of Changes
Other Study ID Numbers: NRA2500065
ECO STUDY
First Submitted: February 12, 2009
First Posted: February 13, 2009
Results First Submitted: April 8, 2009
Results First Posted: June 2, 2009
Last Update Posted: March 13, 2014