Long-Term Safety Extension With SR57667B in Patients With Alzheimer's Disease

NCT ID: NCT00285077

Last Updated: 2008-12-23

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

390 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2006-11-30

Brief Summary

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The primary objective is to assess the long term safety/tolerability of 4 mg/day of SR57667B in comparison to placebo in patients with mild-to-moderate Alzheimer's Disease (AD).

A secondary objective is to describe the long term progression of Alzheimer's symptoms in patients treated by 4 mg/day of SR57667B.

Detailed Description

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Multinational, multicenter, randomized, parallel-group, double-blind, phase II study

Conditions

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Alzheimer Disease

Keywords

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Alzheimer disease nerve growth factors Clinical Trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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SR57667B

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who have participated in Study EFC5286 and completed the study.
* Patient, identified caregiver and, if applicable, patient surrogate (primary relative, legal guardian, medical proxy) have given their informed written consent and are capable of following study procedures specifically for this LTS5283 extension.

Exclusion Criteria

* Females who are pregnant or breast-feeding.
* Females of child bearing potential (premenopausal female biologically capable of becoming pregnant) must have a confirmed negative serum b-HCG pregnancy test at the screening visit,and must use an acceptable method of birth control.
Minimum Eligible Age

50 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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Serge GAUTHIER, MD

Role: STUDY_CHAIR

Scientific Advisory Committee

Jean-Marc ORGOGOZO, MD

Role: STUDY_CHAIR

Scientific Advisory Committee

Philip SCHELTENS, MD

Role: STUDY_CHAIR

Scientific Advisory Committee

Bengt WINBLAD, MD

Role: STUDY_CHAIR

Scientific Advisory Committee

Locations

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Sanofi-Aventis Administrative Office

Laval, , Canada

Site Status

Sanofi-Aventis Administrative Office

Horslholm, , Denmark

Site Status

Sanofi-Aventis Administrative Office

Helsinki, , Finland

Site Status

Sanofi-Aventis Administrative Office

Paris, , France

Site Status

Sanofi-Aventis Administrative Office

Berlin, , Germany

Site Status

Sanofi-Aventis Administrative Office

Midrand, , South Africa

Site Status

Sanofi-Aventis Administrative Office

Bromma, , Sweden

Site Status

Countries

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Canada Denmark Finland France Germany South Africa Sweden

Related Links

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Other Identifiers

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LTS5283

Identifier Type: -

Identifier Source: org_study_id