Effect on Cognitive Performance and Safety/Tolerability of SSR180711C in Mild Alzheimer's Disease

Phase 2

Terminated

• Conditions: Alzheimer's Disease
• Interventions: Drug: SSR180711C; Drug: placebo; Drug: donepezil

• Registration Number: NCT00602680
• Lead Sponsor: Sanofi

Brief Summary

The primary objective of the study is to assess the effect of 3 doses of SSR180711C on cognitive performance in patients with mild Alzheimer's Disease (AD). Other objectives are to assess the safety/tolerability of SSR180711C in patients with mild AD.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-01-16
• Study First Submitted QC: 2008-01-16
• Study First Posted: 2008-01-28
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-17
• Last Update Posted: 2009-07-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Outpatients with diagnosis of mild AD

Exclusion Criteria

• Concomitant or previous treatment by acetylcholinesterase inhibitors and/or memantine
• Medical condition which may interfere with the study
• History of epileptic seizures
• Lens opacity
• Lack of reliable caregiver

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	SSR180711C	dose 1
2	SSR180711C	dose 2
3	SSR180711C	dose 3
4	placebo	-
5	donepezil	-

Primary Outcome Measures

Name	Time	Method
Change in cognitive performance	4 weeks

Secondary Outcome Measures

Name	Time	Method
Cognitive, global, functional and behaviorial assessments	4 weeks

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇫🇷 Paris, France