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

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Donepezil

Criteria

Inclusion criteria:

• 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.

Exclusion criteria:

• 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.