Effect of Different Doses of SAR110894D on Cognition in Patients With Mild to Moderate Alzheimer's Disease on Donepezil

• Conditions: Dementia Alzheimer's type; MedDRA version: 14.1Level: PTClassification code 10012271Term: Dementia Alzheimer's typeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2010-022596-64-DE
• Lead Sponsor: sanofi-aventis recherche & développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-28
• Last Update Posted: 4 November 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 280

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 fixed dose of 5 or
10 mg daily for at least 3 months prior to screening visit.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 27
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 253

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified