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Alzheimer DiseasePhase 3NCT00103649

18-Month Study of the Efficacy of Xaliproden (SR57746A) in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type

A Phase 3 study testing xaliproden (SR57746A) in people with Alzheimer Disease, run by Sanofi at 121 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Alzheimer Disease
What is being tested?
xaliproden (SR57746A)
How many people
1,306 participants
Where
121 sitesin 2 countries
Study dates
Nov 2003to Oct 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

121 sites in 2 countries.

121 sites in 2 countries

United States97 sites

  • DayStar Clinical Research, Inc.

    Akron, Ohio, 44313

  • Neurological Association of Albany P.C.

    Albany, New York, 12208

  • Lovelace Scientific Resources

    Albuquerque, New Mexico, 87108

  • Anaheim Research Center

    Anaheim, California, 92801

  • North East Ohio Health Services

    Beachwood, Ohio, 44122

  • The Memory Clinic

    Bennington, Vermont, 05201

  • UAB Memory Disorders Clinic

    Birmingham, Alabama, 35294-0017

  • Social Psychiatry Research Institute

    Brooklyn, New York, 11235

  • Valley Medical Primary Care

    Centerville, Ohio, 45459

  • Charlottesville Medical Research

    Charlottesville, Virginia, 22911

  • Chicago Center for Clinical Research

    Chicago, Illinois, 60610

  • Coatesville VA Medical Center

    Coatesville, Pennsylvania, 19320

  • Remington-Davis Clinical Research

    Columbus, Ohio, 43215

  • University of Texas - Southwestern Medical Center at Dallas

    Dallas, Texas, 75390-9129

  • Associated Neurologist

    Danbury, Connecticut, 06810

  • Atlantic Institute of Clinical Research

    Daytona Beach, Florida, 32114

  • Radiant Research

    Denver, Colorado, 80212

  • Ruan Neurology

    Des Moines, Iowa, 50314

  • Duke University Medical Center (DUMC) - Dept. of Psychiatry

    Durham, North Carolina, 27710

  • RI Mood and Memory

    East Providence, Rhode Island, 02914

  • Elkhart Clinic, LLC

    Elkhart, Indiana, 46514

  • Radiant Research Eugene

    Eugene, Oregon, 97455

  • Triphase Research, Ltd.

    Franklin, Ohio, 45005

  • TriPhase Research

    Franklin, Ohio, 45005

  • Margolin Brain Institute

    Fresno, California, 93720

  • Clinical Insights

    Glen Burnie, Maryland, 21061

  • Geriatric and Adult Psychiatry, LLC

    Hamden, Connecticut, 06518

  • Berma Research Group

    Hialeah, Florida, 33016

  • Radiant Research Center

    Hoffman Estates, Illinois, 60194

  • Houston Sleep Center

    Houston, Texas, 77024

  • AD Research Center

    Houston, Texas, 77030

  • Parker Jewish Institute for Healthcare and Rehabilitation

    Hyde Park, New York, 11021

  • ClinSearch, Inc.

    Kenilworth, New Jersey, 07033

  • Coordinated Clinical Research

    La Jolla, California, 92037

  • Senior Clinical Trials, Inc.

    Laguna Hills, California, 92653

  • Radiant Research

    Las Vegas, Nevada, 89146

  • Neurobehavioral Research, Inc.

    Lawrence, New York, 11559

  • Radiant Research

    Marietta, Georgia, 30060

  • Clinical Research Institute of Southern Oregon

    Medford, Oregon, 97504

  • CNS Healthcare

    Memphis, Tennessee, 38119

  • Miami Research Associates

    Miami, Florida, 33173

  • Baumel-Eisner Neuromedical Institute in Miami Beach

    Miami, Florida

  • Baumel-Eisner Neuromedical Institute

    Miami, Florida

  • Dean Foundation

    Middleton, Wisconsin, 53562

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Minneapolis VA Medical Center

    Minneapolis, Minnesota, 55417

  • MedARK Clinical Research

    Morganton, North Carolina, 28655

  • The Neuroscience Center of Northern New Jersey

    Morristown, New Jersey, 07960

  • Anchor Research Center

    Naples, Florida, 34102

  • Vanderbilt University Medical Center - Geriatric Psychiatry

    Nashville, Tennessee, 37212

  • Yale University School of Medicine AD Research Unit

    New Haven, Connecticut, 06510

  • Louisiana Research Associates

    New Orleans, Louisiana, 70114

  • Eastside Comprehensive Medical Center

    New York, New York, 10021

  • Behavioral Medical Research of Staten Island

    New York, New York, 10305

  • Healthcore

    Newark, Delaware, 19713-2094

  • Pharmacology Research Institute

    Newport Beach, California, 92660

  • Pearl Clinical Research

    Norristown, Pennsylvania, 19401

  • Segal Institute for Clinical Research

    North Miami, Florida, 33161

  • Pharmacology Research Institute

    Northridge, California, 91324

  • Summit Research Network Michigan, Inc.

    Okemos, Michigan, 48864

  • Global Research and Consulting

    Olean, New York, 14760

  • Clinical Neuroscience Solutions

    Orlando, Florida, 32806

  • Four Rivers Clinical Research

    Paducah, Kentucky, 42003

  • Palm Beach Neurological Center

    Palm Beach Gardens, Florida, 33410

  • Memorial Hospital of Rhode Island

    Pawtucket, Rhode Island, 02860

  • Memory Disorders Clinic

    Philadelphia, Pennsylvania, 19104

  • Radiant Research

    Philadelphia, Pennsylvania, 19115

  • Barrow Neurology Clinics

    Phoenix, Arizona, 85013

  • PsyPharma Clinical Research, Inc.

    Phoenix, Arizona, 85050

  • Clinical Trials Research Services

    Pittsburgh, Pennsylvania, 15206

  • JRMC Clinical Trials Center

    Pittsburgh, Pennsylvania, 15236

  • Neurology Clinical Research, Inc.

    Plantation, Florida, 33324

  • Summit Research Network Inc

    Portland, Oregon, 97210

  • Princeton Medical Institute

    Princeton, New Jersey, 08540

  • Neurology Group of Bergen County

    Ridgewood, New Jersey, 07450

  • Pharmacology Research Institute

    Riverside, California, 92506

  • Pivotal Research Centers, Detroit Office

    Royal Oak, Michigan, 48073

  • Radiant Research SLC

    Salt Lake City, Utah, 84107

  • Innovative Clinical Trials

    San Antonio, Texas, 78229

  • Pacific Research Network

    San Diego, California, 92103

  • Radiant Research

    Scottsdale, Arizona, 85251

  • California Neuroscience Research Medical Group

    Sherman Oaks, California, 91403

  • J. Gary Booker MD

    Shreveport, Louisiana, 71101

  • Avera Research Institute

    Sioux Falls, South Dakota, 57105

  • Southeastern Geriatric Healthcare

    Snellville, Georgia, 30078

  • CNS Clinical Trials

    St. Petersburg, Florida, 33702

  • Internal Medicine Northwest

    Tacoma, Washington, 98405

  • Baumel-Eisner Neuromedical Institute in Miami Beach

    Tamarac, Florida

  • Meridien Research

    Tampa, Florida, 33609

  • Suncoast Gerontology Center USF

    Tampa, Florida, 33617

  • Neurology and Neuroscience Center of Ohio

    Toledo, Ohio, 43623

  • Pacific Research Network

    Vista, California, 92083

  • IPC Research

    Waukesha, Wisconsin, 53188

  • Wenatchee Valley Medical Center

    Wenatchee, Washington, 98801

  • North Texas Neurology Research

    Wichita Falls, Texas, 76301

  • Neurology Associates, PA

    Wilmington, Delaware, 19806

  • Piedmont Medical Research Assoc, Inc.

    Winston-Salem, North Carolina, 27103

Other trials in United States

Canada24 sites

  • Glenrose Rehabilitation Hospital

    Edmonton, Alberta, T5G 0B7

  • NeuroSearch Developments Inc

    Greenfield Park, Quebec, J4V 2J2

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8G 5E4

  • Study site

    Kelowna, British Columbia, V1Y 3G8

  • Kingston General Hospital

    Kingston, Ontario, K7L 2V7

  • St. Joseph's Health Care

    London, Ontario, N6A 4V2

  • Parkwood Hospital - Geriatric Medicine

    London, Ontario, N6C 5J1

  • Davidson Memory Clinic

    Moncton, New Brunswick, E1C 4B7

  • Hopital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2H4

  • Sir Mortimer B. Davis Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Parkinson's & Neurodegenerative Disorders

    Ottawa, Ontario, K1G 4G3

  • S.C.O. Health Centre

    Ottawa, Ontario, K1N 5C8

  • Medical Arts Health Research Group

    Penticton, British Columbia, V2A 5C8

  • Centre de Hospitalier Affilie

    Québec, Quebec, G1J 1Z4

  • Quebec Memory & Motor Skills Disorders

    Québec, Quebec, G1R 3X5

  • Pasqua Hospital

    Regina, Saskatchewan, S4T 1A5

  • St. Joseph's Hospital

    Saint John, New Brunswick, E2L 3L6

  • Institut Universitaire de Geriatrie de Sherbrooke

    Sherbrooke, Quebec, J1J 3H5

  • Toronto Memory Program

    Toronto, Ontario, M3B 2W7

  • University Health Network - The Toronto

    Toronto, Ontario, M5T 2S8

  • Douglas Hospital Research Centre

    Verdun, Quebec, H4H 1R3

  • Can-Med Clinical Research Inc.

    Victoria, British Columbia, V8T 5G1

  • Winnipeg Clinic

    Winnipeg, Manitoba, H1T 2H4

  • Winnipeg Clinic

    Winnipeg, Manitoba, R3C 0N2

Other trials in Canada

About this study

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

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).

Being tested
xaliproden (SR57746A)
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • xaliproden (SR57746A)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Alzheimer's Disease assessment scale-cognitive, clinical dementia rating sum of boxes.

Secondary outcomes (1)

  1. Mini-Mental State Examination, Alzheimer's Disease assessment scale-activities of daily life.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2005 (estimated)
  2. Study startNov 2003
  3. Primary completionOct 2007
  4. Study completionOct 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
1,306 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00103649
Sponsor's protocol ID
EFC2946
Other IDs
SR57746
Status last verified
Aug 2008
First submitted
11 Feb 2005
Last updated
21 Aug 2008
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing xaliproden (SR57746A) in people with Alzheimer Disease, run by Sanofi at 121 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 121 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Alzheimer's Disease assessment scale-cognitive, clinical dementia rating sum of boxes.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00103649.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2008.

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