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Study of the Effect of SR57667B in Patients With Alzheimer's Disease

NCT ID: NCT00285025

Last Updated: 2006-02-01

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

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2005-09-30

Brief Summary

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The primary objective is to demonstrate that SR57667B at the dose of 4 mg/day, in comparison to placebo, decreases the decline in cognitive performance and the global clinical decline over 1 year in patients with mild to moderate AD.

Secondary objectives are to assess the effect of SR57667B on functional decline and its safety/tolerability in patients with mild to moderate AD, and to document plasma concentrations of SR57667 in patients with mild to moderate AD.

Detailed Description

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

Conditions

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Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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SR57667B

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male / female outpatients.
* Age \> 50 years at screening.
* Dementia of Alzheimer's Type (DSM-IV 290.0) according to DSM-IV criteria, Probable AD according to NINCDS-ADRDA criteria, Mini-Mental State Examination score \> 12 and \< 26.
* Untreated or treated for a minimum of 6 months before randomization with a stable dose of the cholinesterase inhibitors
* Generally healthy and ambulatory or ambulatory-aided (i.e., walker or cane).
* Presence of a reliable caregiver.
* 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

Exclusion Criteria

* Any cause of dementia not due to Alzheimer's disease, Delusions, delirium, psychosis, depression, or other significant psychiatric disorder.
* Treatment with any registered or putative cognitive enhancer or disease modifier other than donepezil, rivastigmine or galantamine.
* 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.
* Severe or unstable cardiovascular, respiratory, renal, hematological, endocrinological, neurological or other somatic disease.
* Use of CYP3A4 strong inhibitors
* Evidence (detected by history, physical examination and / or laboratory / ECG tests) of any clinically significant or unstable medical disorder that could interfere with the subject's participation in the clinical trial; interfere with the absorption, metabolism or excretion of the study medication; or interfere with the evaluation of the study drug. Alterations of laboratory tests or ECG findings of potential clinical significance.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

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

Related Links

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http://www.sanofi-aventis.com

Related Info

Other Identifiers

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SR57667B

Identifier Type: -

Identifier Source: secondary_id

EFC5286

Identifier Type: -

Identifier Source: org_study_id