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NCT00895895 · ClinicalTrials.gov registry record · Phase 2
Study Comparing 3 Dosage Levels Of SAM-531 In Outpatients With Mild To Moderate Alzheimer Disease
A Phase 2 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 2
- Development phase
- 526
- Enrollment target
NCT00895895: Clinical Trial Phase 2 study, sponsored by Pfizer.
NCT00895895 is a Phase 2 study that was terminated before completion, run by Pfizer. The registered enrollment target is 526 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (295% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00895895, a Phase 2 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 526 participants
- Enrollment target
Study Summary
The study will evaluate the efficacy and safety of an investigational drug called SAM-531 at three dosage levels. Subjects will receive either one of the 3 dosage levels of SAM-531, donepezil or placebo for the first 24 weeks of the study (period I). Subjects who receive placebo for period I will be assigned to receive the highest dose of SAM-531 SAM-531 for the remaining 28 weeks of the study, while subjects who received one of the three SAM-531 dosage levels or donepezil in period I will continue with the same study drug (period II).
Primary Outcome
14-item scale to assess severity of cognitive impairment in Alzheimer's Disease. Items: word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, recall of test instructions, spoken language ability, word-finding difficulty, comprehension of spoken language, concentration/distractibility, number cancellation and executive maze. Rating scale ranged from 0 (not present) to 5 (severe). Total score was sum of individual scor
Interventions
- DRUG Placebo
- DRUG Donepezil
- DRUG SAM-531 1.5 mg
- DRUG SAM-531 3.0 mg
- DRUG SAM-531 5.0 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 526 participants |
| Start Date | 2009-05 |
| Est. Completion | 2011-05 |
| Phase | Phase 2 |
Why NCT00895895 stopped before completion
NCT00895895 is an interventional study that assigns participants to a tested intervention. The registered 526 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (295% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT00895895 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00895895 about?
NCT00895895 is a clinical study titled "Study Comparing 3 Dosage Levels Of SAM-531 In Outpatients With Mild To Moderate Alzheimer Disease". The study will evaluate the efficacy and safety of an investigational drug called SAM-531 at three dosage levels. Subjects will receive either one of the 3 dosage levels of SAM-531, donepezil or placebo for the first 24 weeks of the study (period I). Subjects who receive placebo for period I will be...
What is the current status of trial NCT00895895?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 526 participants. The study started on 2009-05. Estimated completion is 2011-05.
What interventions are being tested in trial NCT00895895?
The interventions under investigation include: Placebo (DRUG), Donepezil (DRUG), SAM-531 1.5 mg (DRUG), SAM-531 3.0 mg (DRUG), SAM-531 5.0 mg (DRUG).
Who is sponsoring clinical trial NCT00895895?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00895895's enrollment target sits among peer trials
526 65th of 2000 higher than 1,936 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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