Safety and Tolerability of Dimebon in Patients on Memantine, and Memantine Plus Donepezil
A Multi-Center Phase 1 Study of the Safety and Tolerability of Dimebon in Alzheimer's Disease Patients on Memantine (Cohort 1) and Memantine Plus Donepezil (Cohort 2)
1 other identifier
interventional
46
1 country
4
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of dimebon given to Alzheimer's disease patients currently on a stable dose and regimen of memantine or memantine plus donepezil.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2008
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 12, 2009
CompletedFirst Posted
Study publicly available on registry
January 27, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedNovember 10, 2015
November 1, 2015
4 months
January 12, 2009
November 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the safety and tolerability of orally administered dimebon in patients with Alzheimer's disease (AD) on a stable dose and regimen of memantine, or memantine plus donepezil.
Treatment discontinuation due to adverse events, the frequency and severity of adverse events, and clinically significant changes in safety assessments (including physical examination findings, vital signs, laboratory values, and ECGs) in the dimebon group will be compared to those reported in the placebo group.
up to 28 days
Secondary Outcomes (1)
To assess the steady-state pharmacokinetics (PK) of orally-administered dimebon in patients with AD on a stable dose and regimen of memantine, or memantine plus donepezil.
up to 28 days
Study Arms (2)
Dimebon
EXPERIMENTAL20 mg dimebon by mouth 3 times per day
Placebo
PLACEBO COMPARATOR20 mg placebo by mouth 3 times per day
Interventions
Eligibility Criteria
You may qualify if:
- Alzheimer's disease
- On Memantine
- Caregiver who is willing to accompany the patient to all clinic visits
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)
Unknown Facility
Los Alamitos, California, 90720, United States
Unknown Facility
National City, California, 91950, United States
Unknown Facility
Delray Beach, Florida, 33445, United States
Unknown Facility
Orlando, Florida, 32806, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2009
First Posted
January 27, 2009
Study Start
December 1, 2008
Primary Completion
April 1, 2009
Study Completion
August 1, 2010
Last Updated
November 10, 2015
Record last verified: 2015-11