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

NCT00285025 | Completed Phase 2

• 2 other identifiers: EFC5286SR57667B
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Alzheimer Disease

Keywords

Alzheimer disease; nerve growth factors; Clinical Trial

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

SR57667B DRUG

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Related Links

• Related Info

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 31, 2006
• First Posted: February 1, 2006
• Study Start: March 1, 2005
• Study Completion: September 1, 2005
• Last Updated: February 1, 2006

Record last verified: 2006-01