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

July 17, 2009 updated by: Sanofi

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Sanofi-Aventis Administrative Office

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 4
Drug: placebo
duration of treatment: 4 weeks
EXPERIMENTAL: 1
dose 1
Drug: SSR180711C
duration of treatment: 4 weeks
EXPERIMENTAL: 2
dose 2
Drug: SSR180711C
duration of treatment: 4 weeks
EXPERIMENTAL: 3
dose 3
Drug: SSR180711C
duration of treatment: 4 weeks
ACTIVE_COMPARATOR: 5
Drug: donepezil
duration of treatment: 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in cognitive performance
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Cognitive, global, functional and behaviorial assessments
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Chair: Bruno DUBOIS, MD, Scientific Advisory Committee

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (ACTUAL)

July 1, 2008

Study Completion (ACTUAL)

July 1, 2008

Study Registration Dates

First Submitted

January 16, 2008

First Submitted That Met QC Criteria

January 16, 2008

First Posted (ESTIMATE)

January 28, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 20, 2009

Last Update Submitted That Met QC Criteria

July 17, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDY10400
  • SSR180711
  • EudraCT 2007-001639-80

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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