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NCT01266525 · ClinicalTrials.gov registry record · Phase 2
Effect of Different Doses of SAR110894 on Cognition in Patients With Mild to Moderate Alzheimer's Disease on Donepezil
A Phase 2 study of Dementia Alzheimer's Type, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 291
- Enrollment target
- 20
- Study locations
NCT01266525: Completed Phase 2 study of Dementia Alzheimer's Type, sponsored by Sanofi.
NCT01266525 is a Phase 2 study of Dementia Alzheimer's Type that has completed, run by Sanofi. The registered enrollment target is 291 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (119% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01266525, a Phase 2 study of Dementia Alzheimer's Type, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 291 participants
- Enrollment target
- 20
- Study locations
Study Summary
Primary Objective: \- To demonstrate the efficacy of at least one dose of SAR110894 (H3 receptor antagonist) in comparison to placebo on cognitive performance in patients with mild to moderate Alzheimer's disease (AD) while on stable donepezil therapy Secondary Objectives: * To explore the effect of SAR110894 on functional impairment, global clinical status and behavioral disturbances; * To assess the safety/tolerability of SAR110894; * To assess pharmacokinetic (PK) of SAR110894 and concentrations of donepezil; * To explore caregiver time consumption and distress changes.
Conditions Studied
Interventions
- DRUG Donepezil
- DRUG SAR110894
- DRUG placebo (for SAR110894)
Study Locations (20)
Florida
- Investigational Site Number 840003 - Delray Beach
- Investigational Site Number 840015 - Hialeah
- Investigational Site Number 840004 - Jacksonville
- Investigational Site Number 840006 - Miami
- Investigational Site Number 840012 - Orlando
- Investigational Site Number 840011 - Tampa
- Investigational Site Number 840005 - West Palm Beach
California
- Investigational Site Number 840024 - Costa Mesa
- Investigational Site Number 840013 - Fresno
- Investigational Site Number 840030 - La Jolla
- Investigational Site Number 840001 - Redlands
- Investigational Site Number 840002 - Santa Ana
- Investigational Site Number 840026 - Sherman Oaks
Arizona
- Investigational Site Number 840041 - Gilbert
- Investigational Site Number 840032 - Phoenix
Connecticut
- Investigational Site Number 840034 - Darien
Louisiana
- Investigational Site Number 840008 - Baton Rouge
Massachusetts
- Investigational Site Number 840025 - Quincy
Mississippi
- Investigational Site Number 840009 - Hattiesburg
New Jersey
- Investigational Site Number 840040 - Eatontown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 291 participants |
| Start Date | 2011-02 |
| Est. Completion | 2013-01 |
| Phase | Phase 2 |
What the finished NCT01266525 record still lists
NCT01266525 is an interventional study that assigns participants to a tested intervention. The registered 291 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 (119% higher).
The record links to 1 condition, with Dementia Alzheimer's Type appearing as the primary indexed condition, and to 3 interventions - of which Donepezil is the first listed.
NCT01266525 names 20 study sites across 8 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT01266525 about?
NCT01266525 is a clinical study titled "Effect of Different Doses of SAR110894 on Cognition in Patients With Mild to Moderate Alzheimer's Disease on Donepezil". Primary Objective: \- To demonstrate the efficacy of at least one dose of SAR110894 (H3 receptor antagonist) in comparison to placebo on cognitive performance in patients with mild to moderate Alzheimer's disease (AD) while on stable donepezil therapy Secondary Objectives: * To explore the effect...
What is the current status of trial NCT01266525?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 291 participants. The study started on 2011-02. Estimated completion is 2013-01.
What conditions does trial NCT01266525 study?
This clinical trial studies the following conditions: Dementia Alzheimer's Type.
What interventions are being tested in trial NCT01266525?
The interventions under investigation include: Donepezil (DRUG), SAR110894 (DRUG), placebo (for SAR110894) (DRUG).
Who is sponsoring clinical trial NCT01266525?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01266525 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01266525's enrollment target sits among peer trials
291 191st of 2000 higher than 1,810 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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