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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00285025
First received: January 31, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted

January 31, 2006
January 31, 2006
March 2005
Not Provided
ADAS-cog, CDR measured at baseline and at 2, 6, 9 and 12 months.
Same as current
No Changes Posted
MMSE, CGIC, ADCS-ADL, NPI measured at baseline and at 2, 6, 9 and 12 months.
Same as current
Not Provided
Not Provided
 
Study of the Effect of SR57667B in Patients With Alzheimer's Disease
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

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.

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Alzheimer Disease
Drug: SR57667B
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
September 2005
Not Provided

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.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00285025
EFC5286, SR57667B
Not Provided
Not Provided
Sanofi
Not Provided
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
Sanofi
January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP