Effects of ONO-2506PO in Patients With Alzheimer's Disease
Sponsor
Ono Pharma USA Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT00083421
Collaborator
(none)
647
87
37
7.4
0.2
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
647 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Official Title:
Effects of ONO-2506PO in Patients With Alzheimer's Disease
Study Start Date
:
Jun 1, 2004
Actual Study Completion Date
:
Jul 1, 2007
Outcome Measures
Primary Outcome Measures
- Cognitive Function Scale []
- Global Function Scale []
Secondary Outcome Measures
- ADL Scale []
- Psychiatric Symptom Scale []
Eligibility Criteria
Criteria
Ages Eligible for Study:
50 Years
to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kirkland Clinic | Birmingham | Alabama | United States | 35233 |
| 2 | Alzheimers Disease Research Center | Birmingham | Alabama | United States | 35294 |
| 3 | Pivotal Research Center | Mesa | Arizona | United States | 85210 |
| 4 | HOPE Research Institute | Phoenix | Arizona | United States | 85032 |
| 5 | Sun Health Research Institute | Sun City | Arizona | United States | 85351 |
| 6 | University of Arizona | Tucson | Arizona | United States | 85724 |
| 7 | Margolin Brain Institute | Fresno | California | United States | 93720 |
| 8 | UCI Medical Center Neuropsychiatric Center | Orange | California | United States | 92868 |
| 9 | Pacific Neuroscience Medical Group | Oxnard | California | United States | 93030 |
| 10 | The Southwest Institute for Clinical Research, Inc | Rancho Mirage | California | United States | 92270 |
| 11 | Hamid Rabiee, MD | Redding | California | United States | 96001 |
| 12 | Alzheimers Disease Research Center, Univ of CA, San Diego | San Diego | California | United States | 92037 |
| 13 | Pacific Research Network | San Diego | California | United States | 92103 |
| 14 | San Francisco Clinical Research Center | San Francisco | California | United States | 94109 |
| 15 | Apex Research Institute | Santa Ana | California | United States | 92705 |
| 16 | Pacific Neuroscience Medical Group | Santa Barbara | California | United States | 93101 |
| 17 | Neurological Research Institute | Santa Monica | California | United States | 90404 |
| 18 | Radiant Research | Denver | Colorado | United States | 80212 |
| 19 | Research Center for Clinical Studies, Inc. | Darien | Connecticut | United States | 06820 |
| 20 | GAP Clinical Care & Research Center | Hamden | Connecticut | United States | 06518 |
| 21 | Baumel-Eisner Neuromedical Institute | Boca Raton | Florida | United States | 33431 |
| 22 | Neurologic Consultants | Ft. Lauderdale | Florida | United States | 33308 |
| 23 | Baumel-Eisner Neuromedical Institute | Ft. Lauderdale | Florida | United States | 33321 |
| 24 | Gainsville Open MRI | Gainsville | Florida | United States | 32607 |
| 25 | Berma Research Group | Hialeah | Florida | United States | 33016 |
| 26 | Baumel-Eisner Neuromedical Institute | Miami Beach | Florida | United States | 33154 |
| 27 | Miami Jewish and Hospital for the Aged | Miami | Florida | United States | 33137 |
| 28 | Palm Beach Neurological Center | Palm Beach Gardens | Florida | United States | 33410 |
| 29 | Research Site | Port Charlotte | Florida | United States | 33952 |
| 30 | Suncoast Neuroscience Associates | St. Petersburg | Florida | United States | 33701 |
| 31 | Meridien Research | St. Petersburg | Florida | United States | 33709 |
| 32 | Axiom Clinical Research of Florida | Tampa | Florida | United States | 33609 |
| 33 | Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute | Tampa | Florida | United States | 33647 |
| 34 | Premiere Research Institute | West Palm Beach | Florida | United States | 33407 |
| 35 | DeKalb Neurology Associates | Atlanta | Georgia | United States | 30033 |
| 36 | Emory University | Atlanta | Georgia | United States | 30329 |
| 37 | Mercer University | Atlanta | Georgia | United States | 30341 |
| 38 | Rush Alzheimers Disease Center | Chicago | Illinois | United States | 60612 |
| 39 | University of Illinois at Chicago | Chicago | Illinois | United States | 60612 |
| 40 | Radiant Research | Hoffman Estates | Illinois | United States | 60194 |
| 41 | Southern Illinois School of Medicine | Springfield | Illinois | United States | 62702 |
| 42 | Fort Wayne Neurological Center | Fort Wayne | Indiana | United States | 46805 |
| 43 | Center for Alzheimers Disease and Related Disorders | Indianapolis | Indiana | United States | 46202 |
| 44 | Agewell | Indianapolis | Indiana | United States | 46260 |
| 45 | Louisiana State University Health Sciences Cntr - Dept of Psychiatry | New Orleans | Louisiana | United States | 70112 |
| 46 | J. Gary Booker, M.D., APMC | Shreveport | Louisiana | United States | 71101 |
| 47 | St. Louis University Medical Center | St. Louis | Missouri | United States | 63104 |
| 48 | University of Nevada | Las Vegas | Nevada | United States | 89102 |
| 49 | Meridian Institue for Aging | Manchester | New Jersey | United States | 08759 |
| 50 | Mid Atlantic Geriatric Association | Ocean Township | New Jersey | United States | 07712 |
| 51 | St. Francis Medical Center | Trenton | New Jersey | United States | 08629 |
| 52 | Upstate Clinical Reserach, LLC | Albany | New York | United States | 12205 |
| 53 | Upstate Neurology Consults, LLP | Albany | New York | United States | 12205 |
| 54 | Neurological Associates of Albany | Albany | New York | United States | 12208 |
| 55 | Neurobehavioral Research Inc. | Lawrence | New York | United States | 11559 |
| 56 | Eastside Comprehensive Medical Services | New York | New York | United States | 10021 |
| 57 | Global Reserach & Consulting | Olean | New York | United States | 14760 |
| 58 | Monroe Community Hospital | Rochester | New York | United States | 14620 |
| 59 | Behavioral Medical Research | Staten Island | New York | United States | 10305 |
| 60 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 61 | Metrohealth Medical Center | Cleveland | Ohio | United States | 44109 |
| 62 | Ohio State University Hospital | Columbus | Ohio | United States | 43210 |
| 63 | Infinity Research Group, LLC | Oklahoma City | Oklahoma | United States | 73103 |
| 64 | Clinical Pharmaceutical Trials | Tulsa | Oklahoma | United States | 74104 |
| 65 | Medford Neurological and Spine Clinic | Medford | Oregon | United States | 97504 |
| 66 | Summit Research Network | Portland | Oregon | United States | 97223 |
| 67 | Oregon Health and Science University | Portland | Oregon | United States | 97239 |
| 68 | Westmoreland Neurology Associates, Inc. | Greensburg | Pennsylvania | United States | 15601 |
| 69 | University of PA, Section Geriatric Psychiatry | Philadelphia | Pennsylvania | United States | 19104 |
| 70 | Alzheimer Disease Research Center, Univ of Pittsburg | Pittsburg | Pennsylvania | United States | 15213 |
| 71 | Miriam Hospital | Providence | Rhode Island | United States | 02906 |
| 72 | Medical University of South Carolina, Alzheimers Research and Clinical Programs | North Charleston | South Carolina | United States | 29406 |
| 73 | Claghorn Lesem Research Clinic | Bellaire | Texas | United States | 77401 |
| 74 | Memory Research Unit, Univ of Texas Southwest Med Ctr at Dallas | Dallas | Texas | United States | 75390 |
| 75 | Radiant Research San Antonio | San Antonio | Texas | United States | 78229 |
| 76 | Neurological Consultants, PC | Bennington | Vermont | United States | 05201 |
| 77 | Innovative Clinical Research Center | Alexandria | Virginia | United States | 22304 |
| 78 | Medical College of Wisconsin, Department of Neurology | Milwaukee | Wisconsin | United States | 53226 |
| 79 | Independent Psychiatric Consultants | Waukesha | Wisconsin | United States | 53188 |
| 80 | Inova Health Research, Inc. | Kelowna | British Columbia | Canada | V1W 4V5 |
| 81 | University of British Columbia Hospital | Vancouver | British Columbia | Canada | V6T 2B5 |
| 82 | Davidson Memory Clinic | Moncton | New Brunswick | Canada | E1C 4B7 |
| 83 | Parkwood Hospital, Geriatric Medicine | London | Ontario | Canada | N6C 5J1 |
| 84 | SCO Health Centre | Ottawa | Ontario | Canada | KIN 5C8 |
| 85 | Toronto Memory Program | Toronto | Ontario | Canada | M3B 2W7 |
| 86 | Hopital Maisonneuve-Rosemont | Montreal | Quebec | Canada | H1T 2M4 |
| 87 | Pasqua Hospital | Regina | Saskatchewan | Canada | S4T 1A5 |
Sponsors and Collaborators
- Ono Pharma USA Inc
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Ono Pharma USA Inc
ClinicalTrials.gov Identifier:
NCT00083421
Other Study ID Numbers:
- ONO-2506POU010
First Posted:
Jun 18, 2004
Last Update Posted:
Jun 13, 2012
Last Verified:
Jun 1, 2012
Additional relevant MeSH terms: