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NCT00829816 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of Dimebon in Patients on Memantine, and Memantine Plus Donepezil
A Phase 1 study, sponsored by Medivation.
- Completed
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
NCT00829816: Completed Phase 1 study, sponsored by Medivation.
NCT00829816 is a Phase 1 study that has completed, run by Medivation. The registered enrollment target is 46 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00829816, a Phase 1 study, has completed, sponsored by Medivation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Placebo
- DRUG Dimebon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2008-12 |
| Est. Completion | 2010-08 |
| Phase | Phase 1 |
What the finished NCT00829816 record still lists
NCT00829816 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00829816 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00829816 about?
NCT00829816 is a clinical study titled "Safety and Tolerability of Dimebon in Patients on Memantine, and Memantine Plus Donepezil". 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.
What is the current status of trial NCT00829816?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2008-12. Estimated completion is 2010-08.
What interventions are being tested in trial NCT00829816?
The interventions under investigation include: Placebo (DRUG), Dimebon (DRUG).
Who is sponsoring clinical trial NCT00829816?
This trial is sponsored by Medivation, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00829816's enrollment target sits among peer trials
46 1058th of 2000 higher than 935 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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