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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

January 31, 2006

Last Updated Date

January 31, 2006

Start Date ^†

March 2005

Current Primary Outcome Measures ^†

ADAS-cog, CDR measured at baseline and at 2, 6, 9 and 12 months.

Original Primary Outcome Measures ^†

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^†

MMSE, CGIC, ADCS-ADL, NPI measured at baseline and at 2, 6, 9 and 12 months.

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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

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.

Detailed Description

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

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^†

Alzheimer Disease

Intervention ^†

Drug: SR57667B

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

500

Completion Date

September 2005

Primary Completion Date

Eligibility Criteria ^†

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.

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00285025

Responsible Party

Secondary IDs ^††

SR57667B

Study Sponsor ^†

Sanofi-Aventis

Collaborators ^††

Investigators ^†

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

Information Provided By

Sanofi-Aventis

Verification Date

January 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.