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Completed Phase 2 Interventional

Effect of Different Doses of SAR110894 on Cognition in Patients With Mild to Moderate Alzheimer's Disease on Donepezil

ClinicalTrials.gov ID: NCT01266525

Public ClinicalTrials.gov record NCT01266525. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 30, 2026, 10:42 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multinational, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Effect on Cognitive Performance, Safety, and Tolerability of SAR110894D at the Doses of 0.5 mg, 2 mg, and 5 mg/Day for 24 Weeks in Patients With Mild to Moderate Alzheimer's Disease on Stable Donepezil Therapy

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01266525
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Sanofi
Industry
Enrollment
291 participants

Conditions and interventions

Eligibility (public fields only)

Age range
55 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 2011 (Type not available)
Primary completion
Jan 2013 (Actual)
Completion
Jan 2013 (Actual)
Last update posted
Mar 14, 2016

2011 – 2013

United States locations

U.S. sites
27
U.S. states
15
U.S. cities
27
Facility City State ZIP Site status
Investigational Site Number 840041 Gilbert Arizona 85234 —
Investigational Site Number 840032 Phoenix Arizona 85060 —
Investigational Site Number 840024 Costa Mesa California 92626 —
Investigational Site Number 840013 Fresno California 93720 —
Investigational Site Number 840030 La Jolla California 92037 —
Investigational Site Number 840001 Redlands California 92374 —
Investigational Site Number 840002 Santa Ana California 92705 —
Investigational Site Number 840026 Sherman Oaks California 91403 —
Investigational Site Number 840034 Darien Connecticut 06820 —
Investigational Site Number 840003 Delray Beach Florida 33445 —
Investigational Site Number 840015 Hialeah Florida 33016 —
Investigational Site Number 840004 Jacksonville Florida 32216 —
Investigational Site Number 840006 Miami Florida 33155 —
Investigational Site Number 840012 Orlando Florida 32806 —
Investigational Site Number 840011 Tampa Florida 33609-4052 —
Investigational Site Number 840005 West Palm Beach Florida 33407 —
Investigational Site Number 840008 Baton Rouge Louisiana 70808 —
Investigational Site Number 840025 Quincy Massachusetts 02169 —
Investigational Site Number 840009 Hattiesburg Mississippi 39401 —
Investigational Site Number 840040 Eatontown New Jersey 07724 —
Investigational Site Number 840018 Cedarhurst New York 11516 —
Investigational Site Number 840039 Charlotte North Carolina 28204 —
Investigational Site Number 840037 Tulsa Oklahoma 74104 —
Investigational Site Number 840014 Franklin Tennessee 37067 —
Investigational Site Number 840038 Austin Texas 78757 —
Investigational Site Number 840021 Bennington Vermont 05201 —
Investigational Site Number 840031 Williamsburg Virginia 23185 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 55 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01266525, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 14, 2016 · Synced Oct 30, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01266525 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →