Alzheimer's Disease Clinical Trial
Official title:
Effects of ONO-2506PO in Patients With Alzheimer's Disease
The purpose of this study is to establish the presence of an effect of treatment with ONO-2506PO in patients with Alzheimer's Disease, based upon cognitive and global scales.
| Status | Completed |
| Enrollment | 647 |
| Est. completion date | July 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 50 Years to 90 Years |
| Eligibility |
Inclusion Criteria: - Diagnosis of probable Alzheimer's Disease using NINCDS/ADRDA criteria - Standardized MMSE Score of 13 to 24 points (inclusive) - Modified Hachinski score equal or less than 4 Exclusion Criteria: - Serious systemic disease that may preclude survival to study completion - Other illnesses that may include dementive features |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Inova Health Research, Inc. | Kelowna | British Columbia |
| Canada | Parkwood Hospital, Geriatric Medicine | London | Ontario |
| Canada | Davidson Memory Clinic | Moncton | New Brunswick |
| Canada | Hopital Maisonneuve-Rosemont | Montreal | Quebec |
| Canada | SCO Health Centre | Ottawa | Ontario |
| Canada | Pasqua Hospital | Regina | Saskatchewan |
| Canada | Toronto Memory Program | Toronto | Ontario |
| Canada | University of British Columbia Hospital | Vancouver | British Columbia |
| United States | Neurological Associates of Albany | Albany | New York |
| United States | Upstate Clinical Reserach, LLC | Albany | New York |
| United States | Upstate Neurology Consults, LLP | Albany | New York |
| United States | Innovative Clinical Research Center | Alexandria | Virginia |
| United States | DeKalb Neurology Associates | Atlanta | Georgia |
| United States | Emory University | Atlanta | Georgia |
| United States | Mercer University | Atlanta | Georgia |
| United States | Claghorn Lesem Research Clinic | Bellaire | Texas |
| United States | Neurological Consultants, PC | Bennington | Vermont |
| United States | Alzheimers Disease Research Center | Birmingham | Alabama |
| United States | Kirkland Clinic | Birmingham | Alabama |
| United States | Baumel-Eisner Neuromedical Institute | Boca Raton | Florida |
| United States | Rush Alzheimers Disease Center | Chicago | Illinois |
| United States | University of Illinois at Chicago | Chicago | Illinois |
| United States | Metrohealth Medical Center | Cleveland | Ohio |
| United States | Ohio State University Hospital | Columbus | Ohio |
| United States | Memory Research Unit, Univ of Texas Southwest Med Ctr at Dallas | Dallas | Texas |
| United States | Research Center for Clinical Studies, Inc. | Darien | Connecticut |
| United States | Radiant Research | Denver | Colorado |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | Fort Wayne Neurological Center | Fort Wayne | Indiana |
| United States | Margolin Brain Institute | Fresno | California |
| United States | Baumel-Eisner Neuromedical Institute | Ft. Lauderdale | Florida |
| United States | Neurologic Consultants | Ft. Lauderdale | Florida |
| United States | Gainsville Open MRI | Gainsville | Florida |
| United States | Westmoreland Neurology Associates, Inc. | Greensburg | Pennsylvania |
| United States | GAP Clinical Care & Research Center | Hamden | Connecticut |
| United States | Berma Research Group | Hialeah | Florida |
| United States | Radiant Research | Hoffman Estates | Illinois |
| United States | Agewell | Indianapolis | Indiana |
| United States | Center for Alzheimers Disease and Related Disorders | Indianapolis | Indiana |
| United States | University of Nevada | Las Vegas | Nevada |
| United States | Neurobehavioral Research Inc. | Lawrence | New York |
| United States | Meridian Institue for Aging | Manchester | New Jersey |
| United States | Medford Neurological and Spine Clinic | Medford | Oregon |
| United States | Pivotal Research Center | Mesa | Arizona |
| United States | Miami Jewish and Hospital for the Aged | Miami | Florida |
| United States | Baumel-Eisner Neuromedical Institute | Miami Beach | Florida |
| United States | Medical College of Wisconsin, Department of Neurology | Milwaukee | Wisconsin |
| United States | Louisiana State University Health Sciences Cntr - Dept of Psychiatry | New Orleans | Louisiana |
| United States | Eastside Comprehensive Medical Services | New York | New York |
| United States | Medical University of South Carolina, Alzheimers Research and Clinical Programs | North Charleston | South Carolina |
| United States | Mid Atlantic Geriatric Association | Ocean Township | New Jersey |
| United States | Infinity Research Group, LLC | Oklahoma City | Oklahoma |
| United States | Global Reserach & Consulting | Olean | New York |
| United States | UCI Medical Center Neuropsychiatric Center | Orange | California |
| United States | Pacific Neuroscience Medical Group | Oxnard | California |
| United States | Palm Beach Neurological Center | Palm Beach Gardens | Florida |
| United States | University of PA, Section Geriatric Psychiatry | Philadelphia | Pennsylvania |
| United States | HOPE Research Institute | Phoenix | Arizona |
| United States | Alzheimer Disease Research Center, Univ of Pittsburg | Pittsburg | Pennsylvania |
| United States | Research Site | Port Charlotte | Florida |
| United States | Oregon Health and Science University | Portland | Oregon |
| United States | Summit Research Network | Portland | Oregon |
| United States | Miriam Hospital | Providence | Rhode Island |
| United States | The Southwest Institute for Clinical Research, Inc | Rancho Mirage | California |
| United States | Hamid Rabiee, MD | Redding | California |
| United States | Monroe Community Hospital | Rochester | New York |
| United States | Radiant Research San Antonio | San Antonio | Texas |
| United States | Alzheimers Disease Research Center, Univ of CA, San Diego | San Diego | California |
| United States | Pacific Research Network | San Diego | California |
| United States | San Francisco Clinical Research Center | San Francisco | California |
| United States | Apex Research Institute | Santa Ana | California |
| United States | Pacific Neuroscience Medical Group | Santa Barbara | California |
| United States | Neurological Research Institute | Santa Monica | California |
| United States | J. Gary Booker, M.D., APMC | Shreveport | Louisiana |
| United States | Southern Illinois School of Medicine | Springfield | Illinois |
| United States | St. Louis University Medical Center | St. Louis | Missouri |
| United States | Meridien Research | St. Petersburg | Florida |
| United States | Suncoast Neuroscience Associates | St. Petersburg | Florida |
| United States | Behavioral Medical Research | Staten Island | New York |
| United States | Sun Health Research Institute | Sun City | Arizona |
| United States | Axiom Clinical Research of Florida | Tampa | Florida |
| United States | Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute | Tampa | Florida |
| United States | St. Francis Medical Center | Trenton | New Jersey |
| United States | University of Arizona | Tucson | Arizona |
| United States | Clinical Pharmaceutical Trials | Tulsa | Oklahoma |
| United States | Independent Psychiatric Consultants | Waukesha | Wisconsin |
| United States | Premiere Research Institute | West Palm Beach | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Ono Pharma USA Inc |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cognitive Function Scale | |||
| Primary | Global Function Scale | |||
| Secondary | ADL Scale | |||
| Secondary | Psychiatric Symptom Scale |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05040048 -
Taxonomy of Neurodegenerative Diseases : Observational Study in Alzheimer's Disease and Parkinson's Disease
|
||
| Withdrawn |
NCT03316898 -
A FDG-PET Study of AGN-242071 Added to Standard-of-Care (Donepezil ± Memantine) for the Treatment of Participants With Mild to Moderate Alzheimer's Disease
|
Phase 1 | |
| Withdrawn |
NCT02860065 -
CPC-201 Alzheimer's Disease Type Dementia: PET Study
|
Phase 2 | |
| Completed |
NCT01315639 -
New Biomarker for Alzheimer's Disease Diagnostic
|
N/A | |
| Not yet recruiting |
NCT03740178 -
Multiple Dose Trial of MK-4334 in Participants With Alzheimer's Clinical Syndrome (MK-4334-005)
|
Phase 1 | |
| Recruiting |
NCT05607615 -
A 6-Month Study to Evaluate the Safety & Potential Efficacy of Trappsol Cyclo in Patients With Early Alzheimer's Disease
|
Phase 2 | |
| Terminated |
NCT03307993 -
Positron Emission Tomography (PET) Study in Patients With Alzheimer's Disease
|
Phase 1 | |
| Recruiting |
NCT02912936 -
A Medium Chain Triglyceride Intervention for Patients With Alzheimer Disease
|
N/A | |
| Active, not recruiting |
NCT02899091 -
Evaluation of the Safety and Potential Therapeutic Effects of CB-AC-02 in Patients With Alzheimer's Disease
|
Phase 1/Phase 2 | |
| Completed |
NCT02907567 -
Clinical Trial of CT1812 in Mild to Moderate Alzheimer's Disease
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT02868905 -
Identification of Epigenetic Markers Common to Obesity and Alzheimer's Disease in Women
|
N/A | |
| Completed |
NCT02580305 -
SUVN-502 With Donepezil and Memantine for the Treatment of Moderate Alzheimer's Disease- Phase 2a Study
|
Phase 2 | |
| Terminated |
NCT02521558 -
Effectiveness of Home-based Electronic Cognitive Therapy in Alzheimer's Disease
|
N/A | |
| Completed |
NCT02516046 -
18F-AV-1451 Autopsy Study
|
Phase 3 | |
| Recruiting |
NCT02247180 -
Cognitive Rehabilitation in Alzheimer`s Disease
|
N/A | |
| Completed |
NCT02317523 -
Alzheimer's Caregiver Coping: Mental and Physical Health
|
N/A | |
| Completed |
NCT02260167 -
Treatment of Alzheimer's and Dementia With the Metabolism, Infections, Nutrition, Drug Elimination (MIND) Protocol
|
N/A | |
| Terminated |
NCT02220738 -
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABT-957 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors
|
Phase 1 | |
| Completed |
NCT02256306 -
The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study
|
N/A | |
| Withdrawn |
NCT01636596 -
Efficacy of Pulsatile IV Insulin on Cognition and Amyloid Burden in Patients With Alzheimer's Disease
|
N/A |