Study Stopped
The study was halted after a Phase 3 study of dimebon failed to show efficacy.
Study of Combination Therapy With Dimebon and Donepezil (Aricept) in Patients With Alzheimer's Disease
An Open-Label Extension Study of Combination Therapy With Dimebon and Donepezil in Patients With Alzheimer's Disease
1 other identifier
interventional
50
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2008
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
June 23, 2008
CompletedFirst Posted
Study publicly available on registry
June 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedDecember 10, 2015
November 1, 2015
2.3 years
June 23, 2008
November 13, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
To assess the safety of Dimebon in combination with donepezil (Aricept)
week 6, 9, 12, 26 and every 13 weeks thereafter until study discontinuation
Study Arms (1)
Dimebon
EXPERIMENTAL20 mg by mouth 3 times a day
Interventions
Eligibility Criteria
You may qualify if:
- Alzheimer's disease
- On donepezil (Aricept)
- Caregiver who cares for the patient at least 5 days per week
You may not qualify if:
- Unstable medical illnesses or significant hepatic or renal disease
- Other primary psychiatric or neurological disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medivation, Inc.lead
Study Sites (4)
Xenoscience, Inc.
Phoenix, Arizona, 85004, United States
Banner Alzheimer's Institute
Phoenix, Arizona, 85006, United States
Barrow Neurological Institute
Phoenix, Arizona, 85013, United States
Sun Health Research Institute
Sun City, Arizona, 85351, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2008
First Posted
June 25, 2008
Study Start
April 1, 2008
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
December 10, 2015
Record last verified: 2015-11