Clinical trial NCT00083421: Effects of ONO-2506PO in Patients With Alzheimer's Disease
Official title: Effects of ONO-2506PO in Patients With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: Ono Pharmaceutical Co. Ltd
Sponsor class: INDUSTRY
First posted: 2004-06-18
Enrollment: 647
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
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 establish the presence of an effect of treatment with ONO-2506PO in patients with Alzheimer's Disease, based upon cognitive and global scales.


Eligibility criteria: 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

Primary outcomes:
measure: Cognitive Function Scale
measure: Global Function Scale
Secondary outcomes:
measure: ADL Scale
measure: Psychiatric Symptom Scale
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Kirkland Clinic
state: Alabama
city: Birmingham
country: United States
facility: Alzheimers Disease Research Center
state: Alabama
city: Mesa
country: United States
facility: Pivotal Research Center
state: Arizona
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Sun City
country: United States
facility: Sun Health Research Institute
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Fresno
country: United States
facility: Margolin Brain Institute
state: California
city: Orange
country: United States
facility: UCI Medical Center Neuropsychiatric Center
state: California
city: Oxnard
country: United States
facility: Pacific Neuroscience Medical Group
state: California
city: Rancho Mirage
country: United States
facility: The Southwest Institute for Clinical Research, Inc
state: California
city: Redding
country: United States
facility: Hamid Rabiee, MD
state: California
city: San Diego
country: United States
facility: Alzheimers Disease Research Center, Univ of CA, San Diego
state: California
city: San Diego
country: United States
facility: Pacific Research Network
state: California
city: San Francisco
country: United States
facility: San Francisco Clinical Research Center
state: California
city: Santa Ana
country: United States
facility: Apex Research Institute
state: California
city: Santa Barbara
country: United States
facility: Pacific Neuroscience Medical Group
state: California
city: Santa Monica
country: United States
facility: Neurological Research Institute
state: California
city: Denver
country: United States
facility: Radiant Research
state: Colorado
city: Darien
country: United States
facility: Research Center for Clinical Studies, Inc.
state: Connecticut
city: Hamden
country: United States
facility: GAP Clinical Care & Research Center
state: Connecticut
city: Boca Raton
country: United States
facility: Baumel-Eisner Neuromedical Institute
state: Florida
city: Ft. Lauderdale
country: United States
facility: Neurologic Consultants
state: Florida
city: Ft. Lauderdale
country: United States
facility: Baumel-Eisner Neuromedical Institute
state: Florida
city: Gainsville
country: United States
facility: Gainsville Open MRI
state: Florida
city: Hialeah
country: United States
facility: Berma Research Group
state: Florida
city: Miami Beach
country: United States
facility: Baumel-Eisner Neuromedical Institute
state: Florida
city: Miami
country: United States
facility: Miami Jewish and Hospital for the Aged
state: Florida
city: Palm Beach Gardens
country: United States
facility: Palm Beach Neurological Center
state: Florida
city: Port Charlotte
country: United States
facility: Research Site
state: Florida
city: St. Petersburg
country: United States
facility: Suncoast Neuroscience Associates
state: Florida
city: St. Petersburg
country: United States
facility: Meridien Research
state: Florida
city: Tampa
country: United States
facility: Axiom Clinical Research of Florida
state: Florida
city: Tampa
country: United States
facility: Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute
state: Florida
city: Atlanta
country: United States
facility: DeKalb Neurology Associates
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: Mercer University
state: Georgia
city: Chicago
country: United States
facility: Rush Alzheimers Disease Center
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Hoffman Estates
country: United States
facility: Radiant Research
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois School of Medicine
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Neurological Center
state: Indiana
city: Indianapolis
country: United States
facility: Center for Alzheimers Disease and Related Disorders
state: Indiana
city: Indianapolis
country: United States
facility: Agewell
state: Indiana
city: New Orleans
country: United States
facility: Louisiana State University Health Sciences Cntr - Dept of Psychiatry
state: Louisiana
city: Shreveport
country: United States
facility: J. Gary Booker, M.D., APMC
state: Louisiana
city: St. Louis
country: United States
facility: St. Louis University Medical Center
state: Missouri
city: Las Vegas
country: United States
facility: University of Nevada
state: Nevada
city: Manchester
country: United States
facility: Meridian Institue for Aging
state: New Jersey
city: Ocean Township
country: United States
facility: Mid Atlantic Geriatric Association
state: New Jersey
city: Trenton
country: United States
facility: St. Francis Medical Center
state: New Jersey
city: Albany
country: United States
facility: Upstate Clinical Reserach, LLC
state: New York
city: Albany
country: United States
facility: Upstate Neurology Consults, LLP
state: New York
city: Albany
country: United States
facility: Neurological Associates of Albany
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 Services
state: New York
city: Olean
country: United States
facility: Global Reserach & Consulting
state: New York
city: Rochester
country: United States
facility: Monroe Community Hospital
state: New York
city: Staten Island
country: United States
facility: Behavioral Medical Research
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Metrohealth Medical Center
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Infinity Research Group, LLC
state: Oklahoma
city: Tulsa
country: United States
facility: Clinical Pharmaceutical Trials
state: Oklahoma
city: Medford
country: United States
facility: Medford Neurological and Spine Clinic
state: Oregon
city: Portland
country: United States
facility: Summit Research Network
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Greensburg
country: United States
facility: Westmoreland Neurology Associates, Inc.
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of PA, Section Geriatric Psychiatry
state: Pennsylvania
city: Pittsburg
country: United States
facility: Alzheimer Disease Research Center, Univ of Pittsburg
state: Pennsylvania
city: Providence
country: United States
facility: Miriam Hospital
state: Rhode Island
city: North Charleston
country: United States
facility: Medical University of South Carolina, Alzheimers Research and Clinical Programs
state: South Carolina
city: Bellaire
country: United States
facility: Claghorn Lesem Research Clinic
state: Texas
city: Dallas
country: United States
facility: Memory Research Unit, Univ of Texas Southwest Med Ctr at Dallas
state: Texas
city: San Antonio
country: United States
facility: Radiant Research San Antonio
state: Texas
city: Bennington
country: United States
facility: Neurological Consultants, PC
state: Vermont
city: Alexandria
country: United States
facility: Innovative Clinical Research Center
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin, Department of Neurology
state: Wisconsin
city: Waukesha
country: United States
facility: Independent Psychiatric Consultants
state: Wisconsin
city: Kelowna
country: Canada
facility: Inova Health Research, Inc.
state: British Columbia
city: Vancouver
country: Canada
facility: University of British Columbia Hospital
state: British Columbia
city: Moncton
country: Canada
facility: Davidson Memory Clinic
state: New Brunswick
city: London
country: Canada
facility: Parkwood Hospital, Geriatric Medicine
state: Ontario
city: Ottawa
country: Canada
facility: SCO Health Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto Memory Program
state: Ontario
city: Montreal
country: Canada
facility: Hopital Maisonneuve-Rosemont
state: Quebec
city: Regina
country: Canada
facility: Pasqua Hospital
state: Saskatchewan
Study officials:
References: