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Trial record 62 of 331 for:    DONEPEZIL

Donepezil in Treating Patients Who Have Undergone Radiation Therapy for Brain Tumors

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ClinicalTrials.gov Identifier: NCT00369785
Recruitment Status : Completed
First Posted : August 29, 2006
Results First Posted : March 9, 2017
Last Update Posted : June 8, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions Brain Tumors
Metastatic Disease
Interventions Drug: donepezil hydrochloride
Drug: Placebo
Enrollment 198
Recruitment Details Patients were accrued between 2/2008 and 12/2011 at NCI CCOP sites across the nation.
Pre-assignment Details  
Arm/Group Title Arm I - Donepezil Arm II - Control
Hide Arm/Group Description

Weeks 1-6: One 5 mg tablet orally donepezil hydrochloride Weeks 7-24: Two 5mg tablets per day

donepezil hydrochloride: Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily

Weeks 1-6: One placebo tablet per day Weeks 7-24: Two placebo tablets per day

Placebo: Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day

Period Title: Overall Study
Started 99 99
Completed 72 74
Not Completed 27 25
Reason Not Completed
Physician Decision             3             2
Death             1             2
Withdrawal by Subject             7             6
Toxicity             6             4
Never started             0             2
Progression             4             4
Multiple reasons             6             5
Arm/Group Title Arm I - Donepezil Arm II - Control Total
Hide Arm/Group Description

Weeks 1-6: One 5 mg tablet orally donepezil hydrochloride Weeks 7-24: Two 5mg tablets per day

donepezil hydrochloride: Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily

Weeks 1-6: One placebo tablet per day Weeks 7-24: Two placebo tablets per day

Placebo: Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day

Total of all reporting groups
Overall Number of Baseline Participants 99 99 198
Hide Baseline Analysis Population Description
All randomized patients
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 99 participants 198 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
72
  72.7%
83
  83.8%
155
  78.3%
>=65 years
27
  27.3%
16
  16.2%
43
  21.7%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 99 participants 99 participants 198 participants
56.1
(19 to 84)
54.9
(19 to 81)
55.1
(19 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 99 participants 198 participants
Female
56
  56.6%
50
  50.5%
106
  53.5%
Male
43
  43.4%
49
  49.5%
92
  46.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 99 participants 198 participants
Hispanic or Latino
1
   1.0%
0
   0.0%
1
   0.5%
Not Hispanic or Latino
96
  97.0%
97
  98.0%
193
  97.5%
Unknown or Not Reported
2
   2.0%
2
   2.0%
4
   2.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 99 participants 99 participants 198 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   1.0%
0
   0.0%
1
   0.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
   7.1%
9
   9.1%
16
   8.1%
White
91
  91.9%
90
  90.9%
181
  91.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 99 participants 99 participants 198 participants
99 99 198
1.Primary Outcome
Title Memory as Quantified by HVLT-immediate Recall
Hide Description Memory is quantified using the Hopkins Verbal Learning Test (HVLT) - immediate recall. Participants are asked to recall 12 words. Each recalled word is given one point. They are given three trials. The total score is the sum of the recalled words. The range for HVLT-Immediate recall is 0 to 36. Higher scores represent better memory.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with 24 week HVLT data.
Arm/Group Title Arm I - Donepezil Arm II - Control
Hide Arm/Group Description:

Weeks 1-6: One 5 mg tablet orally donepezil hydrochloride Weeks 7-24: Two 5mg tablets per day

donepezil hydrochloride: Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily

Weeks 1-6: One placebo tablet per day Weeks 7-24: Two placebo tablets per day

Placebo: Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day

Overall Number of Participants Analyzed 72 73
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
22.5  (0.45) 22.2  (0.45)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I - Donepezil, Arm II - Control
Comments Null Hypothesis: No difference in immediate recall memory at 24 weeks
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .62
Comments Not adjusted for multiple comparisons.
Method Mixed Models Analysis
Comments [Not Specified]
2.Primary Outcome
Title Memory as Quantified by the HVLT-discrimination
Hide Description In the Hopkins Verbal Learning Test - discrimination, participants are given lists of 12 correct words and 12 incorrect words. HVLT-discrimination is the number of correctly recognized words minus the number incorrectly recognized. The range for this outcome measure is -12 to 12. Higher scores represent better memory.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with 24 week memory data
Arm/Group Title Arm I - Donepezil Arm II - Control
Hide Arm/Group Description:

Weeks 1-6: One 5 mg tablet orally donepezil hydrochloride Weeks 7-24: Two 5mg tablets per day

donepezil hydrochloride: Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily

Weeks 1-6: One placebo tablet per day Weeks 7-24: Two placebo tablets per day

Placebo: Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day

Overall Number of Participants Analyzed 72 73
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
10.1  (0.24) 9.2  (0.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I - Donepezil, Arm II - Control
Comments Null Hypothesis: No difference in discrimination memory between the two groups
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .007
Comments Not adjusted for multiple comparisons.
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame 24 weeks
Adverse Event Reporting Description Analysis includes everyone with post-treatment AE/toxicity data.
 
Arm/Group Title Arm I - Donepezil Arm II - Control
Hide Arm/Group Description

Weeks 1-6: One 5 mg tablet orally donepezil hydrochloride Weeks 7-24: Two 5mg tablets per day

donepezil hydrochloride: Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily

Weeks 1-6: One placebo tablet per day Weeks 7-24: Two placebo tablets per day

Placebo: Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day

All-Cause Mortality
Arm I - Donepezil Arm II - Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I - Donepezil Arm II - Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/96 (12.50%)      10/92 (10.87%)    
Ear and labyrinth disorders     
Auditory/Ear - Other  1  0/96 (0.00%)  0 1/92 (1.09%)  3
Hearing  1  1/96 (1.04%)  2 1/92 (1.09%)  3
Gastrointestinal disorders     
Dental: teeth  1  0/96 (0.00%)  0 1/92 (1.09%)  2
Diarrhea  1  0/96 (0.00%)  0 1/92 (1.09%)  1
Nausea  1  0/96 (0.00%)  0 2/92 (2.17%)  2
Vomiting  1  0/96 (0.00%)  0 2/92 (2.17%)  2
General disorders     
Death NOS  1  1/96 (1.04%)  1 2/92 (2.17%)  2
Dental: peridontal disease  1  0/96 (0.00%)  0 1/92 (1.09%)  1
Fatigue  1  3/96 (3.13%)  5 0/92 (0.00%)  0
Syncope (fainting)  1  1/96 (1.04%)  1 1/92 (1.09%)  1
Infections and infestations     
Infection  1  1/96 (1.04%)  1 1/92 (1.09%)  1
Musculoskeletal and connective tissue disorders     
Muscle weakness  1  2/96 (2.08%)  2 0/92 (0.00%)  0
Muscle Cramps  1  1/96 (1.04%)  1 1/92 (1.09%)  2
Nervous system disorders     
Confusion  1  0/96 (0.00%)  0 1/92 (1.09%)  2
Headache  1  0/96 (0.00%)  0 1/92 (1.09%)  1
Neuropathy: cranial: CN II Vision  1  0/96 (0.00%)  0 1/92 (1.09%)  3
Neuropathy: cranial: CN VII Motor-face; Sensory-taste  1  0/96 (0.00%)  0 1/92 (1.09%)  3
Neuropathy: sensory  1  0/96 (0.00%)  0 1/92 (1.09%)  1
Pain - Other  1  1/96 (1.04%)  1 0/92 (0.00%)  0
Pain: Back  1  1/96 (1.04%)  1 0/92 (0.00%)  0
Seizure  1  1/96 (1.04%)  1 0/92 (0.00%)  0
Somnolence/depressed level of consciousness  1  0/96 (0.00%)  0 1/92 (1.09%)  1
Psychiatric disorders     
Cognitive Disturbance  1  0/96 (0.00%)  0 1/92 (1.09%)  2
Insomnia  1  1/96 (1.04%)  1 1/92 (1.09%)  1
Mood Alteration: Depression  1  1/96 (1.04%)  1 0/92 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Aspiration  1  0/96 (0.00%)  0 1/92 (1.09%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I - Donepezil Arm II - Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   88/96 (91.67%)      80/92 (86.96%)    
Ear and labyrinth disorders     
Dizziness  1  5/96 (5.21%)  5 7/92 (7.61%)  13
Gastrointestinal disorders     
Constipation  1  3/96 (3.13%)  6 5/92 (5.43%)  11
Diarrhea  1  24/96 (25.00%)  29 7/92 (7.61%)  13
Nausea  1  13/96 (13.54%)  19 17/92 (18.48%)  21
Vomiting  1  8/96 (8.33%)  10 4/92 (4.35%)  4
General disorders     
Insomnia  1  43/96 (44.79%)  81 36/92 (39.13%)  70
Metabolism and nutrition disorders     
Fatigue  1  55/96 (57.29%)  105 61/92 (66.30%)  122
Musculoskeletal and connective tissue disorders     
Muscle Weakness  1  2/96 (2.08%)  5 5/92 (5.43%)  11
Muscle Cramps  1  32/96 (33.33%)  58 26/92 (28.26%)  48
Nervous system disorders     
Headache  1  42/96 (43.75%)  70 40/92 (43.48%)  73
Memory Impairment  1  34/96 (35.42%)  83 34/92 (36.96%)  91
Psychiatric disorders     
Anorexia  1  21/96 (21.88%)  33 13/92 (14.13%)  17
Cognitive Disturbance  1  26/96 (27.08%)  64 28/92 (30.43%)  73
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Doug Case
Organization: Wake Forest NCORP Research Base
Phone: (336) 716-1048
EMail: dcase@wakehealth.edu
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT00369785     History of Changes
Other Study ID Numbers: IRB00000551
U10CA081851 ( U.S. NIH Grant/Contract )
REBACCCWFU 91105 ( Other Identifier: NCI )
First Submitted: August 24, 2006
First Posted: August 29, 2006
Results First Submitted: July 15, 2015
Results First Posted: March 9, 2017
Last Update Posted: June 8, 2018