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NCT00766363 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Pharmacokinetic Study of EVP-6124 in Patients With Alzheimer's Disease
A Phase 1 study, sponsored by FORUM Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
NCT00766363: Completed Phase 1 study, sponsored by FORUM Pharmaceuticals.
NCT00766363 is a Phase 1 study that has completed, run by FORUM Pharmaceuticals. The registered enrollment target is 49 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00766363, a Phase 1 study, has completed, sponsored by FORUM Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
Study Summary
This study is being conducted to determine the safety, tolerability, and pharmacokinetics (PK) of three different doses of an investigational medication, EVP-6124, in individuals with mild to moderate Alzheimer's disease who are also taking an Alzheimer's medication (AChEI \[acetylcholinesterase inhibitor\]: either donepezil or rivastigmine). In addition, PK of AChEI medications will be assessed. Cognitive function will be evaluated on an exploratory basis.
Primary Outcome
All adverse experiences spontaneously reported by subject and/or observed by investigator and repeated clinical evaluation of physical examinations, vital signs, 12-lead ECG (electrocardiogram), ambulatory ECG, and laboratory tests (hematology/blood chemistry/urinalysis)
Interventions
- DRUG Donepezil
- DRUG EVP-6124 (0.1 mg/day)
- DRUG EVP-6124 (0.3 mg/day)
- DRUG EVP-6124 (1.0 mg/day)
- DRUG Comparator: Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2008-10 |
| Est. Completion | 2009-03 |
| Phase | Phase 1 |
What the finished NCT00766363 record still lists
NCT00766363 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% lower).
The record links to 0 conditions, and to 5 interventions - of which Donepezil is the first listed.
NCT00766363 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00766363 about?
NCT00766363 is a clinical study titled "Safety, Tolerability, and Pharmacokinetic Study of EVP-6124 in Patients With Alzheimer's Disease". This study is being conducted to determine the safety, tolerability, and pharmacokinetics (PK) of three different doses of an investigational medication, EVP-6124, in individuals with mild to moderate Alzheimer's disease who are also taking an Alzheimer's medication (AChEI \[acetylcholinesterase inh...
What is the current status of trial NCT00766363?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2008-10. Estimated completion is 2009-03.
What interventions are being tested in trial NCT00766363?
The interventions under investigation include: Donepezil (DRUG), EVP-6124 (0.1 mg/day) (DRUG), EVP-6124 (0.3 mg/day) (DRUG), EVP-6124 (1.0 mg/day) (DRUG), Comparator: Placebo (DRUG).
Who is sponsoring clinical trial NCT00766363?
This trial is sponsored by FORUM Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00766363's enrollment target sits among peer trials
49 1017th of 2000 higher than 976 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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