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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
  Purpose

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 Intervention Phase
Alzheimer Disease
Drug: SR57667B
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • ADAS-cog, CDR measured at baseline and at 2, 6, 9 and 12 months.

Secondary Outcome Measures:
  • MMSE, CGIC, ADCS-ADL, NPI measured at baseline and at 2, 6, 9 and 12 months.

Estimated Enrollment: 500
Study Start Date: March 2005
Estimated Study Completion Date: September 2005
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00285025

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:
No publications provided

ClinicalTrials.gov Identifier: NCT00285025     History of Changes
Other Study ID Numbers: EFC5286, SR57667B
Study First Received: January 31, 2006
Last Updated: January 31, 2006
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Sanofi:
Alzheimer disease
nerve growth factors
Clinical Trial

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 23, 2014