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

• ClinicalTrials.gov Identifier: NCT00285025
• Recruitment Status: Completed
• First Posted: February 1, 2006
• Last Update Posted: February 1, 2006
• Sponsor: Sanofi
• Information provided by: Sanofi

Study Description

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

Study Design

• 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

Arms and Interventions

Outcome Measures

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.

Eligibility Criteria

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

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.

Contacts and Locations

Sponsors and Collaborators

Sanofi

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

More Information

Additional Information:

Related Info 

• ClinicalTrials.gov Identifier: NCT00285025
• Other Study ID Numbers: EFC5286; SR57667B
• First Posted: February 1, 2006
• 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:

Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders