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

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: January 31, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted

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 Intervention Phase
Alzheimer Disease Drug: SR57667B Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

Further study details as provided by Sanofi:

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

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

Estimated Enrollment: 500
Study Start Date: March 2005
Estimated Study Completion Date: September 2005
Detailed Description:
Multinational, multicenter, randomized, parallel-group, double-blind, phase II study

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
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.
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Please refer to this study by its identifier: NCT00285025

Sponsors and Collaborators
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
  More Information

Additional Information: Identifier: NCT00285025     History of Changes
Other Study ID Numbers: EFC5286
Study First Received: January 31, 2006
Last Updated: January 31, 2006

Keywords provided by Sanofi:
Alzheimer disease
nerve growth factors
Clinical Trial

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders processed this record on June 23, 2017