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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00285025
Recruitment Status : Completed
First Posted : February 1, 2006
Last Update Posted : February 1, 2006
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Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: SR57667B Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase II, Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled, Efficacy, Safety and Tolerability Study of SR57667B in Patients With Mild-to-Moderate Alzheimer's Disease
Study Start Date : March 2005
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. ADAS-cog, CDR measured at baseline and at 2, 6, 9 and 12 months.

Secondary Outcome Measures :
  1. MMSE, CGIC, ADCS-ADL, NPI measured at baseline and at 2, 6, 9 and 12 months.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00285025

Sponsors and Collaborators
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Study Chair: Serge GAUTHIER, MD Scientific Advisory Committee
Study Chair: Jean-Marc ORGOGOZO, MD Scientific Advisory Committee
Study Chair: Philip SCHELTENS, MD Scientific Advisory Committee
Study Chair: Bengt WINBLAD, MD Scientific Advisory Committee
Additional Information:
Layout table for additonal information Identifier: NCT00285025    
Other Study ID Numbers: EFC5286
First Posted: February 1, 2006    Key Record Dates
Last Update Posted: February 1, 2006
Last Verified: January 2006
Keywords provided by Sanofi:
Alzheimer disease
nerve growth factors
Clinical Trial
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders