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Trial record 83 of 331 for:    DONEPEZIL

A Study Versus E2020 10mg Followed by an Open-label Extension Phase to Explore the Safety of E2020 SR 23 mg in Japanese Subjects With Severe Alzheimer's Type Dementia

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ClinicalTrials.gov Identifier: NCT01276353
Recruitment Status : Completed
First Posted : January 13, 2011
Results First Posted : August 1, 2014
Last Update Posted : August 8, 2014
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Alzheimer's Type Dementia
Intervention Drug: E2020
Enrollment 45
Recruitment Details  
Pre-assignment Details  
Arm/Group Title E2020 SR 23 mg E2020 10 mg
Hide Arm/Group Description E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase. E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
Period Title: Double-blind
Started 22 23
Completed 19 23
Not Completed 3 0
Reason Not Completed
Adverse Event             2             0
Withdrawal by Subject             1             0
Period Title: Extension
Started 19 23
Completed 12 14
Not Completed 7 9
Reason Not Completed
Adverse Event             2             5
Withdrawal by Subject             1             2
Withdrawal of study drug 4 days in a row             3             1
Physician Decision             1             0
Prohibited concomitant medications             0             1
Arm/Group Title E2020 SR 23 mg E2020 10 mg Total
Hide Arm/Group Description E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase. E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase. Total of all reporting groups
Overall Number of Baseline Participants 22 23 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 23 participants 45 participants
79.3  (9.8) 73.6  (10.8) 76.4  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 23 participants 45 participants
Female
16
  72.7%
16
  69.6%
32
  71.1%
Male
6
  27.3%
7
  30.4%
13
  28.9%
Hachinski Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Scores on a Scale
Number Analyzed 22 participants 23 participants 45 participants
1.1  (1.3) 0.7  (1.1) 0.9  (1.2)
[1]
Measure Description: The Hachinski Ischaemic Score (HIS) is an attempt to differentiate Alzheimer's type dementia and multi-infarct dementia. It uses a system of 13 features of with a score of 1 or 2, adding the scores together for a final score. A cut-off score less than or equal to 4 for Dementia of Alzheimer’s Type (DAT) and greater than or equal to 7 for Vascular Dememntia (VaD) has a sensitivity of 89% and a specificity of 89%.
1.Primary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of E2020 on Visits 2 and 3
Hide Description [Not Specified]
Time Frame Visit 2 [Day1] and Visit 3 [Day 15]
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Analysis Set: the group of subjects who had received at least one quantifiable E2020 concentration in plasma
Arm/Group Title E2020 SR 23 mg E2020 10 mg
Hide Arm/Group Description:
E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once in the morning daily for 52 weeks in the extension phase.
E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
Overall Number of Participants Analyzed 22 23
Mean (Standard Deviation)
Unit of Measure: ng/mL
Visit 2 126.503  (31.27) 97.006  (32.934)
Visit 3 127.335  (40.654) 66.081  (24)
2.Secondary Outcome
Title Cmax of E2020 on Visits 2 and 3 According to Cytochrome P450 2D6 (CYP2D6) Phenotype Status
Hide Description All subjects were identified as Extensive Metabolizer [EM] or Intermediate Metabolizer [IM] predicted from their CYP2D6 phenotypes. Ultra-rapid Metabolizer (UM) and Poor Metabolizer (PM) were not identified in any subject. Since the analysis population i
Time Frame Visit 2 [Day1] and Visit 3 [Day 15]
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Analysis Set
Arm/Group Title E2020 SR 23 mg E2020 10 mg (EM)
Hide Arm/Group Description:
E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
Overall Number of Participants Analyzed 22 23
Mean (Standard Deviation)
Unit of Measure: ng/mL
Visit 2 EM [IR: n=16, SR: n=17] 117.999  (28.898) 98.117  (32.323)
Visit 2 IM [IR: n=5, SR: n=4] 161.363  (18.761) 104.294  (23.962)
Visit 3 EM [IR: n=16, SR: n=15] 116.771  (31.663) 63.896  (20.662)
Visit 2 IM [IR: n=5, SR: n=3] 182.953  (48.422) 79.802  (24.984)
Time Frame Up to 54 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title E2020 SR 23 mg (Double-blind) E2020 10 mg (Double-blind) E2020 SR 23 mg (Extension) E2020 10 mg (Extension)
Hide Arm/Group Description E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
All-Cause Mortality
E2020 SR 23 mg (Double-blind) E2020 10 mg (Double-blind) E2020 SR 23 mg (Extension) E2020 10 mg (Extension)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
E2020 SR 23 mg (Double-blind) E2020 10 mg (Double-blind) E2020 SR 23 mg (Extension) E2020 10 mg (Extension)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/23 (0.00%)   0/19 (0.00%)   1/23 (4.35%) 
Nervous system disorders         
Ataxia * 1  0/22 (0.00%)  0/23 (0.00%)  0/19 (0.00%)  1/23 (4.35%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA V. 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
E2020 SR 23 mg (Double-blind) E2020 10 mg (Double-blind) E2020 SR 23 mg (Extension) E2020 10 mg (Extension)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   13/22 (59.09%)   2/23 (8.70%)   9/19 (47.37%)   16/23 (69.57%) 
Blood and lymphatic system disorders         
Anaemia * 1  0/22 (0.00%)  0/23 (0.00%)  1/19 (5.26%)  0/23 (0.00%) 
Eye disorders         
Eye Discharge * 1  0/22 (0.00%)  0/23 (0.00%)  1/19 (5.26%)  0/23 (0.00%) 
Gastrointestinal disorders         
Diarrhoea * 1  3/22 (13.64%)  1/23 (4.35%)  2/19 (10.53%)  0/23 (0.00%) 
Nausea * 1  3/22 (13.64%)  1/23 (4.35%)  0/19 (0.00%)  7/23 (30.43%) 
Vomiting * 1  4/22 (18.18%)  1/23 (4.35%)  0/19 (0.00%)  7/23 (30.43%) 
Epulis * 1  0/22 (0.00%)  0/23 (0.00%)  1/19 (5.26%)  0/23 (0.00%) 
Gastrointestinal haemorrhage * 1  0/22 (0.00%)  0/23 (0.00%)  1/19 (5.26%)  0/23 (0.00%) 
Constipation * 1  0/22 (0.00%)  0/23 (0.00%)  0/19 (0.00%)  2/23 (8.70%) 
General disorders         
Oedema * 1  0/22 (0.00%)  0/23 (0.00%)  1/19 (5.26%)  0/23 (0.00%) 
Oedema peripheral * 1  0/22 (0.00%)  0/23 (0.00%)  1/19 (5.26%)  0/23 (0.00%) 
Investigations         
Electrocardiogram QT prolonged * 1  2/22 (9.09%)  0/23 (0.00%)  1/19 (5.26%)  0/23 (0.00%) 
Weight decreased * 1  2/22 (9.09%)  0/23 (0.00%)  3/19 (15.79%)  1/23 (4.35%) 
Blood pressure decreased * 1  0/22 (0.00%)  0/23 (0.00%)  1/19 (5.26%)  0/23 (0.00%) 
Blood pressure increased * 1  0/22 (0.00%)  0/23 (0.00%)  1/19 (5.26%)  0/23 (0.00%) 
Blood uric acid increased * 1  1/22 (4.55%)  0/23 (0.00%)  1/19 (5.26%)  0/23 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite * 1  6/22 (27.27%)  0/23 (0.00%)  3/19 (15.79%)  4/23 (17.39%) 
Nervous system disorders         
Somnolence * 1  2/22 (9.09%)  0/23 (0.00%)  1/19 (5.26%)  4/23 (17.39%) 
Dyskinesia * 1  0/22 (0.00%)  0/23 (0.00%)  1/19 (5.26%)  0/23 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA V. 15.0
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: Naoki Kubota
Organization: Clinical Development. JAC PCU. Eisai Co., Ltd.
Phone: +81-3-3817-5245
Layout table for additonal information
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01276353     History of Changes
Other Study ID Numbers: E2020-J081-221
First Submitted: January 12, 2011
First Posted: January 13, 2011
Results First Submitted: February 24, 2014
Results First Posted: August 1, 2014
Last Update Posted: August 8, 2014