Alzheimer Disease Clinical Trial
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
| Verified date | August 2008 |
| Source | Sanofi |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 1306 |
| Est. completion date | October 2007 |
| Est. primary completion date | October 2007 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 50 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Glenrose Rehabilitation Hospital | Edmonton, | Alberta |
| Canada | NeuroSearch Developments Inc | Greenfield Park | Quebec |
| Canada | St. Joseph's Healthcare Hamilton | Hamilton, | Ontario |
| Canada | Kingston General Hospital | Kingston | Ontario |
| Canada | Parkwood Hospital - Geriatric Medicine | London | Ontario |
| Canada | St. Joseph's Health Care | London | Ontario |
| Canada | Davidson Memory Clinic | Moncton, | New Brunswick |
| Canada | Hopital Maisonneuve-Rosemont | Montreal | Quebec |
| Canada | Sir Mortimer B. Davis Jewish General Hospital | Montreal | Quebec |
| Canada | Parkinson's & Neurodegenerative Disorders | Ottawa | Ontario |
| Canada | S.C.O. Health Centre | Ottawa, | Ontario |
| Canada | Medical Arts Health Research Group | Penticton | British Columbia |
| Canada | Centre de Hospitalier Affilie | Quebec | |
| Canada | Quebec Memory & Motor Skills Disorders | Quebec City | Quebec |
| Canada | Pasqua Hospital | Regina | Saskatchewan |
| Canada | St. Joseph's Hospital | Saint John, | New Brunswick |
| Canada | Institut Universitaire de Geriatrie de Sherbrooke | Sherbrooke | Quebec |
| Canada | University Health Network - The Toronto | Toronto | Ontario |
| Canada | Toronto Memory Program | Toronto, | Ontario |
| Canada | Douglas Hospital Research Centre | Verdun | Quebec |
| Canada | Can-Med Clinical Research Inc. | Victoria | British Columbia |
| Canada | Winnipeg Clinic | Winnipeg | Manitoba |
| Canada | Winnipeg Clinic | Winnipeg, | Manitoba |
| United States | DayStar Clinical Research, Inc. | Akron | Ohio |
| United States | Neurological Association of Albany P.C. | Albany | New York |
| United States | Lovelace Scientific Resources | Albuquerque | New Mexico |
| United States | Anaheim Research Center | Anaheim | California |
| United States | North East Ohio Health Services | Beachwood | Ohio |
| United States | The Memory Clinic | Bennington, | Vermont |
| United States | UAB Memory Disorders Clinic | Birmingham | Alabama |
| United States | Social Psychiatry Research Institute | Brooklyn, | New York |
| United States | Valley Medical Primary Care | Centerville | Ohio |
| United States | Charlottesville Medical Research | Charlottesville | Virginia |
| United States | Chicago Center for Clinical Research | Chicago | Illinois |
| United States | Coatesville VA Medical Center | Coatesville | Pennsylvania |
| United States | Remington-Davis Clinical Research | Columbus | Ohio |
| United States | University of Texas - Southwestern Medical Center at Dallas | Dallas, | Texas |
| United States | Associated Neurologist | Danbury, | Connecticut |
| United States | Atlantic Institute of Clinical Research | Daytona Beach | Florida |
| United States | Radiant Research | Denver | Colorado |
| United States | Ruan Neurology | Des Moines | Iowa |
| United States | Duke University Medical Center (DUMC) - Dept. of Psychiatry | Durham | North Carolina |
| United States | RI Mood and Memory | East Providence | Rhode Island |
| United States | Elkhart Clinic, LLC | Elkhart, | Indiana |
| United States | Radiant Research Eugene | Eugene | Oregon |
| United States | Triphase Research, Ltd. | Franklin | Ohio |
| United States | TriPhase Research | Franklin, | Ohio |
| United States | Margolin Brain Institute | Fresno | California |
| United States | Clinical Insights | Glen Burnie | Maryland |
| United States | Geriatric and Adult Psychiatry, LLC | Hamden | Connecticut |
| United States | Berma Research Group | Hialeah | Florida |
| United States | Radiant Research Center | Hoffman Estates | Illinois |
| United States | AD Research Center | Houston | Texas |
| United States | Houston Sleep Center | Houston | Texas |
| United States | Parker Jewish Institute for Healthcare and Rehabilitation | Hyde Park, | New York |
| United States | ClinSearch, Inc. | Kenilworth, | New Jersey |
| United States | Coordinated Clinical Research | La Jolla | California |
| United States | Senior Clinical Trials, Inc. | Laguna Hills | California |
| United States | Radiant Research | Las Vegas | Nevada |
| United States | Neurobehavioral Research, Inc. | Lawrence | New York |
| United States | Radiant Research | Marietta | Georgia |
| United States | Clinical Research Institute of Southern Oregon | Medford | Oregon |
| United States | CNS Healthcare | Memphis | Tennessee |
| United States | Baumel-Eisner Neuromedical Institute | Miami | Florida |
| United States | Baumel-Eisner Neuromedical Institute in Miami Beach | Miami | Florida |
| United States | Miami Research Associates | Miami | Florida |
| United States | Dean Foundation | Middleton | Wisconsin |
| United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
| United States | Minneapolis VA Medical Center | Minneapolis | Minnesota |
| United States | MedARK Clinical Research | Morganton | North Carolina |
| United States | The Neuroscience Center of Northern New Jersey | Morristown | New Jersey |
| United States | Anchor Research Center | Naples | Florida |
| United States | Vanderbilt University Medical Center - Geriatric Psychiatry | Nashville | Tennessee |
| United States | Yale University School of Medicine AD Research Unit | New Haven | Connecticut |
| United States | Louisiana Research Associates | New Orleans | Louisiana |
| United States | Behavioral Medical Research of Staten Island | New York | New York |
| United States | Eastside Comprehensive Medical Center | New York | New York |
| United States | Healthcore | Newark | Delaware |
| United States | Pharmacology Research Institute | Newport Beach | California |
| United States | Pearl Clinical Research | Norristown | Pennsylvania |
| United States | Segal Institute for Clinical Research | North Miami | Florida |
| United States | Pharmacology Research Institute | Northridge | California |
| United States | Summit Research Network Michigan, Inc. | Okemos | Michigan |
| United States | Global Research and Consulting | Olean | New York |
| United States | Clinical Neuroscience Solutions | Orlando | Florida |
| United States | Four Rivers Clinical Research | Paducah | Kentucky |
| United States | Palm Beach Neurological Center | Palm Beach Gardens, | Florida |
| United States | Memorial Hospital of Rhode Island | Pawtucket | Rhode Island |
| United States | Memory Disorders Clinic | Philadelphia | Pennsylvania |
| United States | Radiant Research | Philadelphia | Pennsylvania |
| United States | Barrow Neurology Clinics | Phoenix | Arizona |
| United States | PsyPharma Clinical Research, Inc. | Phoenix | Arizona |
| United States | Clinical Trials Research Services | Pittsburgh | Pennsylvania |
| United States | JRMC Clinical Trials Center | Pittsburgh | Pennsylvania |
| United States | Neurology Clinical Research, Inc. | Plantation | Florida |
| United States | Summit Research Network Inc | Portland | Oregon |
| United States | Princeton Medical Institute | Princeton, | New Jersey |
| United States | Neurology Group of Bergen County | Ridgewood | New Jersey |
| United States | Pharmacology Research Institute | Riverside | California |
| United States | Pivotal Research Centers, Detroit Office | Royal Oak, | Michigan |
| United States | Radiant Research SLC | Salt Lake City | Utah |
| United States | Innovative Clinical Trials | San Antonio | Texas |
| United States | Pacific Research Network | San Diego, | California |
| United States | Radiant Research | Scottsdale | Arizona |
| United States | California Neuroscience Research Medical Group | Sherman Oaks | California |
| United States | J. Gary Booker MD | Shreveport, | Louisiana |
| United States | Avera Research Institute | Sioux Falls | South Dakota |
| United States | Southeastern Geriatric Healthcare | Snellville | Georgia |
| United States | CNS Clinical Trials | St Petersburg | Florida |
| United States | Internal Medicine Northwest | Tacoma | Washington |
| United States | Baumel-Eisner Neuromedical Institute in Miami Beach | Tamarac | Florida |
| United States | Meridien Research | Tampa | Florida |
| United States | Suncoast Gerontology Center USF | Tampa | Florida |
| United States | Neurology and Neuroscience Center of Ohio | Toledo | Ohio |
| United States | Pacific Research Network | Vista, | California |
| United States | IPC Research | Waukesha | Wisconsin |
| United States | Wenatchee Valley Medical Center | Wenatchee | Washington |
| United States | North Texas Neurology Research | Wichita Falls | Texas |
| United States | Neurology Associates, PA | Wilmington | Delaware |
| United States | Piedmont Medical Research Assoc, Inc. | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Sanofi |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Alzheimer's Disease assessment scale-cognitive, clinical dementia rating sum of boxes. | |||
| Secondary | Mini-Mental State Examination, Alzheimer's Disease assessment scale-activities of daily life. |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04044495 -
Sleep, Rhythms and Risk of Alzheimer's Disease
|
N/A | |
| Completed |
NCT04079803 -
PTI-125 for Mild-to-moderate Alzheimer's Disease Patients
|
Phase 2 | |
| Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
| Recruiting |
NCT04520698 -
Utilizing Palliative Leaders In Facilities to Transform Care for Alzheimer's Disease
|
N/A | |
| Active, not recruiting |
NCT04606420 -
Can Lifestyle Changes Reverse Early-Stage Alzheimer's Disease
|
N/A | |
| Recruiting |
NCT05820919 -
Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase
|
N/A | |
| Terminated |
NCT03672474 -
REGEnLIFE RGn530 - Feasibility Pilot
|
N/A | |
| Completed |
NCT03430648 -
Is Tau Protein Linked to Mobility Function?
|
||
| Recruiting |
NCT04522739 -
Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Alzheimer's Disease
|
Phase 4 | |
| Recruiting |
NCT05288842 -
Tanycytes in Alzheimer's Disease and Frontotemporal Dementia
|
||
| Recruiting |
NCT04949750 -
Efficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease
|
N/A | |
| Recruiting |
NCT05557409 -
A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation
|
Phase 3 | |
| Completed |
NCT06194552 -
A Multiple Dose Study of the Safety and Pharmacokinetics of NTRX-07
|
Phase 1 | |
| Completed |
NCT03239561 -
Evaluation of Tau Protein in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants
|
Early Phase 1 | |
| Completed |
NCT03184467 -
Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Alzheimer Patients
|
Phase 2 | |
| Active, not recruiting |
NCT03676881 -
Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
|
||
| Terminated |
NCT03487380 -
Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease
|
N/A | |
| Completed |
NCT05538455 -
Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases
|
N/A | |
| Recruiting |
NCT05328115 -
A Study on the Safety, Tolerability and Immunogenicity of ALZ-101 in Participants With Early Alzheimer's Disease
|
Phase 1 | |
| Completed |
NCT05562583 -
SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support
|
N/A |