Clinical trial NCT00103649: 18-Month Study of the Efficacy 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: 2005-02-14
Enrollment: 1306
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 State Examination score of 16 to 26 (inclusive)
  * Potential participant may be treated with conventional Alzheimer's disease therapy and must be on 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: Birmingham
country: United States
facility: UAB Memory Disorders Clinic
state: Alabama
city: Phoenix
country: United States
facility: Barrow Neurology Clinics
state: Arizona
city: Phoenix
country: United States
facility: PsyPharma Clinical Research, Inc.
state: Arizona
city: Scottsdale
country: United States
facility: Radiant Research
state: Arizona
city: Anaheim
country: United States
facility: Anaheim Research Center
state: California
city: Fresno
country: United States
facility: Margolin Brain Institute
state: California
city: La Jolla
country: United States
facility: Coordinated Clinical Research
state: California
city: Laguna Hills
country: United States
facility: Senior Clinical Trials, Inc.
state: California
city: Newport Beach
country: United States
facility: Pharmacology Research Institute
state: California
city: Northridge
country: United States
facility: Pharmacology Research Institute
state: California
city: Riverside
country: United States
facility: Pharmacology Research Institute
state: California
city: San Diego,
country: United States
facility: Pacific Research Network
state: California
city: Sherman Oaks
country: United States
facility: California Neuroscience Research Medical Group
state: California
city: Vista,
country: United States
facility: Pacific Research Network
state: California
city: Denver
country: United States
facility: Radiant Research
state: Colorado
city: Danbury,
country: United States
facility: Associated Neurologist
state: Connecticut
city: Hamden
country: United States
facility: Geriatric and Adult Psychiatry, LLC
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine AD Research Unit
state: Connecticut
city: Newark
country: United States
facility: Healthcore
state: Delaware
city: Wilmington
country: United States
facility: Neurology Associates, PA
state: Delaware
city: Daytona Beach
country: United States
facility: Atlantic Institute of Clinical Research
state: Florida
city: Hialeah
country: United States
facility: Berma Research Group
state: Florida
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Miami
country: United States
facility: Baumel-Eisner Neuromedical Institute in Miami Beach
state: Florida
city: Miami
country: United States
facility: Baumel-Eisner Neuromedical Institute
state: Florida
city: Naples
country: United States
facility: Anchor Research Center
state: Florida
city: North Miami
country: United States
facility: Segal Institute for Clinical Research
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions
state: Florida
city: Palm Beach Gardens,
country: United States
facility: Palm Beach Neurological Center
state: Florida
city: Plantation
country: United States
facility: Neurology Clinical Research, Inc.
state: Florida
city: St Petersburg
country: United States
facility: CNS Clinical Trials
state: Florida
city: Tamarac
country: United States
facility: Baumel-Eisner Neuromedical Institute in Miami Beach
state: Florida
city: Tampa
country: United States
facility: Meridien Research
state: Florida
city: Tampa
country: United States
facility: Suncoast Gerontology Center USF
state: Florida
city: Marietta
country: United States
facility: Radiant Research
state: Georgia
city: Snellville
country: United States
facility: Southeastern Geriatric Healthcare
state: Georgia
city: Chicago
country: United States
facility: Chicago Center for Clinical Research
state: Illinois
city: Hoffman Estates
country: United States
facility: Radiant Research Center
state: Illinois
city: Elkhart,
country: United States
facility: Elkhart Clinic, LLC
state: Indiana
city: Des Moines
country: United States
facility: Ruan Neurology
state: Iowa
city: Paducah
country: United States
facility: Four Rivers Clinical Research
state: Kentucky
city: New Orleans
country: United States
facility: Louisiana Research Associates
state: Louisiana
city: Shreveport,
country: United States
facility: J. Gary Booker MD
state: Louisiana
city: Glen Burnie
country: United States
facility: Clinical Insights
state: Maryland
city: Okemos
country: United States
facility: Summit Research Network Michigan, Inc.
state: Michigan
city: Royal Oak,
country: United States
facility: Pivotal Research Centers, Detroit Office
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis VA Medical Center
state: Minnesota
city: Las Vegas
country: United States
facility: Radiant Research
state: Nevada
city: Kenilworth,
country: United States
facility: ClinSearch, Inc.
state: New Jersey
city: Morristown
country: United States
facility: The Neuroscience Center of Northern New Jersey
state: New Jersey
city: Princeton,
country: United States
facility: Princeton Medical Institute
state: New Jersey
city: Ridgewood
country: United States
facility: Neurology Group of Bergen County
state: New Jersey
city: Albuquerque
country: United States
facility: Lovelace Scientific Resources
state: New Mexico
city: Albany
country: United States
facility: Neurological Association of Albany P.C.
state: New York
city: Brooklyn,
country: United States
facility: Social Psychiatry Research Institute
state: New York
city: Hyde Park,
country: United States
facility: Parker Jewish Institute for Healthcare and Rehabilitation
state: New York
city: Lawrence
country: United States
facility: Neurobehavioral Research, Inc.
state: New York
city: New York
country: United States
facility: Eastside Comprehensive Medical Center
state: New York
city: New York
country: United States
facility: Behavioral Medical Research of Staten Island
state: New York
city: Olean
country: United States
facility: Global Research and Consulting
state: New York
city: Durham
country: United States
facility: Duke University Medical Center (DUMC) - Dept. of Psychiatry
state: North Carolina
city: Morganton
country: United States
facility: MedARK Clinical Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Medical Research Assoc, Inc.
state: North Carolina
city: Akron
country: United States
facility: DayStar Clinical Research, Inc.
state: Ohio
city: Beachwood
country: United States
facility: North East Ohio Health Services
state: Ohio
city: Centerville
country: United States
facility: Valley Medical Primary Care
state: Ohio
city: Columbus
country: United States
facility: Remington-Davis Clinical Research
state: Ohio
city: Franklin,
country: United States
facility: TriPhase Research
state: Ohio
city: Franklin
country: United States
facility: Triphase Research, Ltd.
state: Ohio
city: Toledo
country: United States
facility: Neurology and Neuroscience Center of Ohio
state: Ohio
city: Eugene
country: United States
facility: Radiant Research Eugene
state: Oregon
city: Medford
country: United States
facility: Clinical Research Institute of Southern Oregon
state: Oregon
city: Portland
country: United States
facility: Summit Research Network Inc
state: Oregon
city: Coatesville
country: United States
facility: Coatesville VA Medical Center
state: Pennsylvania
city: Norristown
country: United States
facility: Pearl Clinical Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: Memory Disorders Clinic
state: Pennsylvania
city: Philadelphia
country: United States
facility: Radiant Research
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Clinical Trials Research Services
state: Pennsylvania
city: Pittsburgh
country: United States
facility: JRMC Clinical Trials Center
state: Pennsylvania
city: East Providence
country: United States
facility: RI Mood and Memory
state: Rhode Island
city: Pawtucket
country: United States
facility: Memorial Hospital of Rhode Island
state: Rhode Island
city: Sioux Falls
country: United States
facility: Avera Research Institute
state: South Dakota
city: Memphis
country: United States
facility: CNS Healthcare
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center - Geriatric Psychiatry
state: Tennessee
city: Dallas,
country: United States
facility: University of Texas - Southwestern Medical Center at Dallas
state: Texas
city: Houston
country: United States
facility: Houston Sleep Center
state: Texas
city: Houston
country: United States
facility: AD Research Center
state: Texas
city: San Antonio
country: United States
facility: Innovative Clinical Trials
state: Texas
city: Wichita Falls
country: United States
facility: North Texas Neurology Research
state: Texas
city: Salt Lake City
country: United States
facility: Radiant Research SLC
state: Utah
city: Bennington,
country: United States
facility: The Memory Clinic
state: Vermont
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Tacoma
country: United States
facility: Internal Medicine Northwest
state: Washington
city: Wenatchee
country: United States
facility: Wenatchee Valley Medical Center
state: Washington
city: Middleton
country: United States
facility: Dean Foundation
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Waukesha
country: United States
facility: IPC Research
state: Wisconsin
city: Edmonton,
country: Canada
facility: Glenrose Rehabilitation Hospital
state: Alberta
city: Kelowna
country: Canada
state: British Columbia
city: Penticton
country: Canada
facility: Medical Arts Health Research Group
state: British Columbia
city: Victoria
country: Canada
facility: Can-Med Clinical Research Inc.
state: British Columbia
city: Winnipeg,
country: Canada
facility: Winnipeg Clinic
state: Manitoba
city: Winnipeg
country: Canada
facility: Winnipeg Clinic
state: Manitoba
city: Moncton,
country: Canada
facility: Davidson Memory Clinic
state: New Brunswick
city: Saint John,
country: Canada
facility: St. Joseph's Hospital
state: New Brunswick
city: Hamilton,
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: London
country: Canada
facility: St. Joseph's Health Care
state: Ontario
city: London
country: Canada
facility: Parkwood Hospital - Geriatric Medicine
state: Ontario
city: Ottawa,
country: Canada
facility: S.C.O. Health Centre
state: Ontario
city: Ottawa
country: Canada
facility: Parkinson's & Neurodegenerative Disorders
state: Ontario
city: Toronto,
country: Canada
facility: Toronto Memory Program
state: Ontario
city: Toronto
country: Canada
facility: University Health Network - The Toronto
state: Ontario
city: Greenfield Park
country: Canada
facility: NeuroSearch Developments Inc
state: Quebec
city: Montreal
country: Canada
facility: Hopital Maisonneuve-Rosemont
state: Quebec
city: Montreal
country: Canada
facility: Sir Mortimer B. Davis Jewish General Hospital
state: Quebec
city: Quebec City
country: Canada
facility: Quebec Memory & Motor Skills Disorders
state: Quebec
city: Sherbrooke
country: Canada
facility: Institut Universitaire de Geriatrie de Sherbrooke
state: Quebec
city: Verdun
country: Canada
facility: Douglas Hospital Research Centre
state: Quebec
city: Regina
country: Canada
facility: Pasqua Hospital
state: Saskatchewan
city: Quebec
country: Canada
facility: Centre de Hospitalier Affilie
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References: