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

Alzheimer Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00285025
• Other study ID #: EFC5286
• Secondary ID: SR57667B
• Status: Completed
• Phase: Phase 2
• First received: January 31, 2006
• Last updated: January 31, 2006
• Start date: March 2005
• Est. completion date: September 2005

Study information

• Verified date: January 2006
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Canada: Health CanadaGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• SR57667B

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ADAS-cog, CDR measured at baseline and at 2, 6, 9 and 12 months.
Secondary	MMSE, CGIC, ADCS-ADL, NPI measured at baseline and at 2, 6, 9 and 12 months.

External Links

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