Long-Term Safety Extension With SR57667B in Patients With Alzheimer's Disease

Alzheimer Disease Clinical Trial

Official title:

Long-Term Safety Extension of Phase II Study EFC5286 of SR57667B in Patients With Mild-to-Moderate Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00285077
• Other study ID #: LTS5283
• Status: Completed
• Phase: Phase 2
• First received: January 31, 2006
• Last updated: December 22, 2008
• Start date: March 2004
• Est. completion date: November 2006

Study information

• Verified date: December 2008
• 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: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

The primary objective is to assess the long term safety/tolerability of 4 mg/day of SR57667B in comparison to placebo in patients with mild-to-moderate Alzheimer's Disease (AD).

A secondary objective is to describe the long term progression of Alzheimer's symptoms in patients treated by 4 mg/day of SR57667B.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 390
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Patients who have participated in Study EFC5286 and completed the study.

• 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 specifically for this LTS5283 extension.

Exclusion Criteria:

• 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.

Study Design

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• SR57667B

Locations

Country	Name	City	State
Canada	Sanofi-Aventis Administrative Office	Laval
Denmark	Sanofi-Aventis Administrative Office	Horslholm
Finland	Sanofi-Aventis Administrative Office	Helsinki
France	Sanofi-Aventis Administrative Office	Paris
Germany	Sanofi-Aventis Administrative Office	Berlin
South Africa	Sanofi-Aventis Administrative Office	Midrand
Sweden	Sanofi-Aventis Administrative Office	Bromma

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Canada,  Denmark,  Finland,  France,  Germany,  South Africa,  Sweden, 

Outcome

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

External Links

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