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

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SR57667B
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer disease, nerve growth factors, Clinical Trial

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    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.

    Full Information

    First Posted
    January 31, 2006
    Last Updated
    January 31, 2006
    Sponsor
    Sanofi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00285025
    Brief Title
    Study of the Effect of SR57667B in Patients With Alzheimer's Disease
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2006
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2005 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Sanofi

    4. Oversight

    5. 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.
    Detailed Description
    Multinational, multicenter, randomized, parallel-group, double-blind, phase II study

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alzheimer Disease
    Keywords
    Alzheimer disease, nerve growth factors, Clinical Trial

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    500 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    SR57667B
    Primary Outcome Measure Information:
    Title
    ADAS-cog, CDR measured at baseline and at 2, 6, 9 and 12 months.
    Secondary Outcome Measure Information:
    Title
    MMSE, CGIC, ADCS-ADL, NPI measured at baseline and at 2, 6, 9 and 12 months.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Serge GAUTHIER, MD
    Organizational Affiliation
    Scientific Advisory Committee
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Jean-Marc ORGOGOZO, MD
    Organizational Affiliation
    Scientific Advisory Committee
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Philip SCHELTENS, MD
    Organizational Affiliation
    Scientific Advisory Committee
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Bengt WINBLAD, MD
    Organizational Affiliation
    Scientific Advisory Committee
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Links:
    URL
    http://www.sanofi-aventis.com
    Description
    Related Info

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

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