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

Completed · Phase 2 · Has a placebo group

Conditions studied: Dementia Alzheimer's Type

In brief

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.

Key facts

Study ID

NCT01266525

Run by

Sanofi

People needed

291

Starts

2011-02-01

Expected to finish

2013-01-01

Last updated by the study team

2016-03-14

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with diagnosis of Alzheimer's Disease (AD) (Cannot be dementia from strokes or other causes).
• Patient is on stable and well-tolerated donepezil treatment at a dose of either 5 or 10 mg daily for at least 3 months prior to screening visit.

You may not qualify if…

• Age <55 years old.
• Psychotic features, agitation, or behavioral problems within the last 3 months.
• Patients unable to comply with ophthalmologic monitoring.
• Lack of consistent and reliable caregiver.
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Where it is running

• Investigational Site Number 840032 — Phoenix, Arizona, United States
• Investigational Site Number 840024 — Costa Mesa, California, United States
• Investigational Site Number 840013 — Fresno, California, United States
• Investigational Site Number 840030 — La Jolla, California, United States
• Investigational Site Number 840001 — Redlands, California, United States
• Investigational Site Number 840002 — Santa Ana, California, United States
• Investigational Site Number 840026 — Sherman Oaks, California, United States
• Investigational Site Number 840034 — Darien, Connecticut, United States
• Investigational Site Number 840003 — Delray Beach, Florida, United States
• Investigational Site Number 840015 — Hialeah, Florida, United States
• Investigational Site Number 840004 — Jacksonville, Florida, United States
• Investigational Site Number 840006 — Miami, Florida, United States
• Investigational Site Number 840012 — Orlando, Florida, United States
• Investigational Site Number 840011 — Tampa, Florida, United States
• Investigational Site Number 840005 — West Palm Beach, Florida, United States
• Investigational Site Number 840008 — Baton Rouge, Louisiana, United States
• Investigational Site Number 840025 — Quincy, Massachusetts, United States
• Investigational Site Number 840009 — Hattiesburg, Mississippi, United States
• Investigational Site Number 840040 — Eatontown, New Jersey, United States
• Investigational Site Number 840018 — Cedarhurst, New York, United States
• Investigational Site Number 840039 — Charlotte, North Carolina, United States
• Investigational Site Number 840037 — Tulsa, Oklahoma, United States
• Investigational Site Number 840014 — Franklin, Tennessee, United States
• Investigational Site Number 840038 — Austin, Texas, United States
• Investigational Site Number 840041 — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.