Back to resultsStudy of Combination Therapy With Dimebon and Donepezil (Aricept) in Patients With Alzheimer's Disease
Primary Purpose
Alzheimer's Disease
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
dimebon
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility Criteria
Inclusion Criteria:
- Alzheimer's disease
- On donepezil (Aricept)
- Caregiver who cares for the patient at least 5 days per week
Exclusion Criteria:
- Unstable medical illnesses or significant hepatic or renal disease
- Other primary psychiatric or neurological disorders
Sites / Locations
- Xenoscience, Inc.
- Banner Alzheimer's Institute
- Barrow Neurological Institute
- Sun Health Research Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dimebon
Arm Description
20 mg by mouth 3 times a day
Outcomes
Primary Outcome Measures
To assess the safety of Dimebon in combination with donepezil (Aricept)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00704782
Brief Title
Study of Combination Therapy With Dimebon and Donepezil (Aricept) in Patients With Alzheimer's Disease
Official Title
An Open-Label Extension Study of Combination Therapy With Dimebon and Donepezil in Patients With Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Why Stopped
The study was halted after a Phase 3 study of dimebon failed to show efficacy.
Study Start Date
April 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medivation, Inc.
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess the safety and efficacy of Dimebon in combination with donepezil (Aricept) in the treatment of Alzheimer's disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dimebon
Arm Type
Experimental
Arm Description
20 mg by mouth 3 times a day
Intervention Type
Drug
Intervention Name(s)
dimebon
Primary Outcome Measure Information:
Title
To assess the safety of Dimebon in combination with donepezil (Aricept)
Time Frame
week 6, 9, 12, 26 and every 13 weeks thereafter until study discontinuation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Alzheimer's disease
On donepezil (Aricept)
Caregiver who cares for the patient at least 5 days per week
Exclusion Criteria:
Unstable medical illnesses or significant hepatic or renal disease
Other primary psychiatric or neurological disorders
Facility Information:
Facility Name
Xenoscience, Inc.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Banner Alzheimer's Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Sun Health Research Institute
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Combination Therapy With Dimebon and Donepezil (Aricept) in Patients With Alzheimer's Disease
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