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Trial record 74 of 331 for:    DONEPEZIL

A 28-Week Open Label Extension Study Evaluating Safety and Tolerability of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment

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: NCT00934375
Recruitment Status : Completed
First Posted : July 8, 2009
Results First Posted : July 8, 2009
Last Update Posted : January 14, 2014
Sponsor:
Information provided by:
Eisai Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Mild Cognitive Impairment
Interventions Drug: Aricept (donepezil hydrochloride)
Drug: placebo
Enrollment 145
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Donepezil Placebo
Hide Arm/Group Description 5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day. [Not Specified]
Period Title: Overall Study
Started 68 77
Completed 55 55
Not Completed 13 22
Arm/Group Title Donepezil Placebo Total
Hide Arm/Group Description 5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day. [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 68 77 145
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 68 participants 77 participants 145 participants
71.7  (8.46) 73.4  (8.73) 72.6  (8.62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 77 participants 145 participants
Female
30
  44.1%
36
  46.8%
66
  45.5%
Male
38
  55.9%
41
  53.2%
79
  54.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 68 participants 77 participants 145 participants
68 77 145
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events
Hide Description Overview of Treatment-Emergent Adverse Events and Safety Population (TEAEs)
Time Frame Baseline, Week 6, Week 12 and Week 28.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Donepezil Placebo
Hide Arm/Group Description:
5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day.
[Not Specified]
Overall Number of Participants Analyzed 68 77
Measure Type: Number
Unit of Measure: Participants
Any Serious TEAE 3 2
Any Severe TEAE 2 3
Any possibly/probably drug-related TEAE 16 32
Any TEAE causing discontinuation of study drug. 7 17
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Donepezil Placebo
Hide Arm/Group Description 5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day. [Not Specified]
All-Cause Mortality
Donepezil Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Donepezil Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   3/68 (4.41%)   2/77 (2.60%) 
Injury, poisoning and procedural complications     
Pelvic Fracture  1/68 (1.47%)  0/77 (0.00%) 
Musculoskeletal and connective tissue disorders     
Osteoarthritis  0/68 (0.00%)  1/77 (1.30%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  2/68 (2.94%)  0/77 (0.00%) 
Prostate Cancer  0/68 (0.00%)  1/77 (1.30%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Donepezil Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   11/68 (16.18%)   20/77 (25.97%) 
Gastrointestinal disorders     
Diarrhea  4/68 (5.88%)  12/77 (15.58%) 
Nausea  1/68 (1.47%)  7/77 (9.09%) 
Musculoskeletal and connective tissue disorders     
Muscle Spasms  6/68 (8.82%)  7/77 (9.09%) 
Psychiatric disorders     
Abnormal dreams  1/68 (1.47%)  5/77 (6.49%) 
Insomnia  3/68 (4.41%)  5/77 (6.49%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Anita Murthy, Study Director
Organization: Eisai Inc.
Phone: 201-692-1100
Layout table for additonal information
Responsible Party: James Prodafikas, Study Director, Eisai Inc.
ClinicalTrials.gov Identifier: NCT00934375     History of Changes
Other Study ID Numbers: E2020-A001-414
First Submitted: May 14, 2009
First Posted: July 8, 2009
Results First Submitted: July 25, 2011
Results First Posted: July 8, 2009
Last Update Posted: January 14, 2014