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

Tracking Information

First Received Date ^ICMJE

January 31, 2006

Last Updated Date

January 31, 2006

Start Date ^ICMJE

March 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Alzheimer Disease

Intervention ^ICMJE

Drug: SR57667B

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

500

Completion Date

September 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00285025

Other Study ID Numbers ^ICMJE

EFC5286, SR57667B

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Sanofi

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Verification Date

January 2006

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

To Top