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

Primary Purpose

Alzheimer's Disease

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
SSR180711C
donepezil
placebo
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer, cognitive

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

1

2

3

4

5

Arm Description

dose 1

dose 2

dose 3

Outcomes

Primary Outcome Measures

Change in cognitive performance

Secondary Outcome Measures

Cognitive, global, functional and behaviorial assessments

Full Information

First Posted
January 16, 2008
Last Updated
July 17, 2009
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00602680
Brief Title
Effect on Cognitive Performance and Safety/Tolerability of SSR180711C in Mild Alzheimer's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Terminated
Why Stopped
Insufficient expected benefit risk
Study Start Date
January 2008 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer, cognitive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
dose 1
Arm Title
2
Arm Type
Experimental
Arm Description
dose 2
Arm Title
3
Arm Type
Experimental
Arm Description
dose 3
Arm Title
4
Arm Type
Placebo Comparator
Arm Title
5
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
SSR180711C
Intervention Description
duration of treatment: 4 weeks
Intervention Type
Drug
Intervention Name(s)
donepezil
Intervention Description
duration of treatment: 4 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
duration of treatment: 4 weeks
Primary Outcome Measure Information:
Title
Change in cognitive performance
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Cognitive, global, functional and behaviorial assessments
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno DUBOIS, MD
Organizational Affiliation
Scientific Advisory Committee
Official's Role
Study Chair
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Paris
Country
France

12. IPD Sharing Statement

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

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