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

NCT ID: NCT00602680

Last Updated: 2009-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-07-31

Brief Summary

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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

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

dose 1

Group Type EXPERIMENTAL

SSR180711C

Intervention Type DRUG

duration of treatment: 4 weeks

2

dose 2

Group Type EXPERIMENTAL

SSR180711C

Intervention Type DRUG

duration of treatment: 4 weeks

3

dose 3

Group Type EXPERIMENTAL

SSR180711C

Intervention Type DRUG

duration of treatment: 4 weeks

4

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

duration of treatment: 4 weeks

5

Group Type ACTIVE_COMPARATOR

donepezil

Intervention Type DRUG

duration of treatment: 4 weeks

Interventions

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SSR180711C

duration of treatment: 4 weeks

Intervention Type DRUG

donepezil

duration of treatment: 4 weeks

Intervention Type DRUG

placebo

duration of treatment: 4 weeks

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis

Principal Investigators

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Bruno DUBOIS, MD

Role: STUDY_CHAIR

Scientific Advisory Committee

Locations

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Sanofi-Aventis Administrative Office

Paris, , France

Site Status

Countries

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France

Other Identifiers

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SSR180711

Identifier Type: -

Identifier Source: secondary_id

EudraCT 2007-001639-80

Identifier Type: -

Identifier Source: secondary_id

PDY10400

Identifier Type: -

Identifier Source: org_study_id

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