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

Alzheimer's Disease Clinical Trial

Official title:

A Multicenter, Double-blind, Parallel-group, Placebo-controlled Study of the Effect on Cognitive Performance and Safety/Tolerability of SSR180711C for 4 Weeks, Using Donepezil as Calibrator, in Patients With Mild Alzheimer's Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00602680
• Other study ID #: PDY10400
• Secondary ID: SSR180711EudraCT
• Status: Terminated
• Phase: Phase 2
• First received: January 16, 2008
• Last updated: July 17, 2009
• Start date: January 2008
• Est. completion date: July 2008

Study information

• Verified date: July 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• SSR180711C
duration of treatment: 4 weeks
• donepezil
duration of treatment: 4 weeks
• placebo
duration of treatment: 4 weeks

Locations

Country	Name	City	State
France	Sanofi-Aventis Administrative Office	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cognitive performance		4 weeks	No
Secondary	Cognitive, global, functional and behaviorial assessments		4 weeks	No