Clinical trial NCT00104013: Study of Xaliproden (SR57746A) in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type
Official title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled, 18-Month Study of the Efficacy of Xaliproden in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer Disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-02-21
Enrollment: 1455
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess xaliproden's potential capacity of slowing the deterioration of cognitive and global functions in patients with mild to moderate Alzheimer's disease. The patients participating in this study will take orally once daily xaliproden or placebo (inactive substance pill).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of probable Alzheimer's disease using NINCDS-ADRDA criteria

  * Mild to moderate degree of severity of dementia as assessed by the Mini-Mental Status Examination score of 16 to 26 (inclusive)
  * Potential participant may be treated with conventional Alzheimer's disease therapy and must be on a stable dose for at least 6 months prior to the randomization and during the entire study period
  * Potential participant must have a reliable caregiver and must be living in a community or in an assisted living facility
  * Mother tongue is English, Spanish or French (oral and written fluency)
  * Signed informed consent from potential participant or legal representative and identified caregiver

Exclusion Criteria:

* Potential participant with any other cause of dementia.
* Potential participant with serious health problems other than Alzheimer's disease
* Use of an investigational drug within two months prior to randomization or during this study

Primary outcomes:
measure: Alzheimer's Disease assessment scale-cognitive, clinical dementia rating sum of boxes.
Secondary outcomes:
measure: Mini-Mental State Examination, Alzheimer's Disease assessment scale-activities of daily life.
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Neurological Physicians of Arizona, Inc.
state: Arizona
city: Mesa
country: United States
facility: Pivotal Research Centers
state: Arizona
city: Peoria
country: United States
facility: Pivotal Research Centers
state: Arizona
city: Tucson
country: United States
facility: Northwest NeuroSpecialists
state: Arizona
city: Oceanside
country: United States
facility: Optimum Health Services
state: California
city: Redlands
country: United States
facility: Anderson Clinical Research
state: California
city: Farmington
country: United States
facility: Univ. of CT Health Center
state: Connecticut
city: Jacksonville
country: United States
facility: CNS Healthcare
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Pompano Beach
country: United States
facility: Memory Disorder Center
state: Florida
city: Fort Wayne
country: United States
facility: Neurological Center
state: Indiana
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research
state: Kansas
city: Florence
country: United States
facility: Hartford Research Group
state: Kentucky
city: Lexington
country: United States
facility: Lexington Clinic
state: Kentucky
city: New Orleans
country: United States
facility: LSUHSC Geriatric Psychiatry
state: Louisiana
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Saginaw
country: United States
facility: Synergy Medical
state: Michigan
city: Jackson
country: United States
facility: University Medical Center, Dept. of Psychiatry Clinical Trials
state: Mississippi
city: St. Louis
country: United States
facility: Radiant Research, Inc.
state: Missouri
city: Moorestown
country: United States
facility: Center For Emotional Fitness
state: New Jersey
city: Piscataway
country: United States
facility: Ubhc/Umdnj667
state: New Jersey
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Jenkintown
country: United States
facility: The Clinical Trial Center
state: Pennsylvania
city: Greer
country: United States
facility: Radiant Research
state: South Carolina
city: North Charleston
country: United States
facility: Alzheimer's Research & Clinical Programs
state: South Carolina
city: Johnson City
country: United States
facility: Harmony Research, Inc
state: Tennessee
city: Lake Jackson
country: United States
facility: R/D Clinical Research, Inc.
state: Texas
city: Wichita Falls
country: United States
facility: Grayline Clinical Drug Trial
state: Texas
city: Alexandria
country: United States
facility: The Innovative Clinical Research Center
state: Virginia
city: Norfolk
country: United States
facility: Eastern Virginia Medical School - The Glennan Center For Geriatrics "Gerontology"
state: Virginia
city: Richmond
country: United States
facility: National Clinical Research, Inc
state: Virginia
city: Macquarie Park, New South Wales
country: Australia
facility: sanofi-aventis Australia & New Zealand administrative office
city: Paris
country: France
facility: Sanofi-Aventis Administrative Office
city: Causeway Bay
country: Hong Kong
facility: Sanofi-Aventis Administrative Office
city: Milano
country: Italy
facility: Sanfoi-Aventis Administrative Office
city: Gouda
country: Netherlands
facility: Sanofi-Aventis Administrative Office
city: Singapore
country: Singapore
facility: Sanofi-Aventis Administrative Office
city: Midrand
country: South Africa
facility: Sanofi-Aventis Administrative Office
city: Barcelona
country: Spain
facility: Sanofi-Aventis Administrative Office
city: Taipei
country: Taiwan
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References: