Effects of ONO-2506PO in Patients With Alzheimer's Disease

NCT ID: NCT00083421

Last Updated: 2012-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

647 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2007-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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ONO-2506PO

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ono Pharma USA Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kirkland Clinic

Birmingham, Alabama, United States

Site Status

Alzheimers Disease Research Center

Birmingham, Alabama, United States

Site Status

Pivotal Research Center

Mesa, Arizona, United States

Site Status

HOPE Research Institute

Phoenix, Arizona, United States

Site Status

Sun Health Research Institute

Sun City, Arizona, United States

Site Status

University of Arizona

Tucson, Arizona, United States

Site Status

Margolin Brain Institute

Fresno, California, United States

Site Status

UCI Medical Center Neuropsychiatric Center

Orange, California, United States

Site Status

Pacific Neuroscience Medical Group

Oxnard, California, United States

Site Status

The Southwest Institute for Clinical Research, Inc

Rancho Mirage, California, United States

Site Status

Hamid Rabiee, MD

Redding, California, United States

Site Status

Alzheimers Disease Research Center, Univ of CA, San Diego

San Diego, California, United States

Site Status

Pacific Research Network

San Diego, California, United States

Site Status

San Francisco Clinical Research Center

San Francisco, California, United States

Site Status

Apex Research Institute

Santa Ana, California, United States

Site Status

Pacific Neuroscience Medical Group

Santa Barbara, California, United States

Site Status

Neurological Research Institute

Santa Monica, California, United States

Site Status

Radiant Research

Denver, Colorado, United States

Site Status

Research Center for Clinical Studies, Inc.

Darien, Connecticut, United States

Site Status

GAP Clinical Care & Research Center

Hamden, Connecticut, United States

Site Status

Baumel-Eisner Neuromedical Institute

Boca Raton, Florida, United States

Site Status

Neurologic Consultants

Fort Lauderdale, Florida, United States

Site Status

Baumel-Eisner Neuromedical Institute

Fort Lauderdale, Florida, United States

Site Status

Gainsville Open MRI

Gainsville, Florida, United States

Site Status

Berma Research Group

Hialeah, Florida, United States

Site Status

Miami Jewish and Hospital for the Aged

Miami, Florida, United States

Site Status

Baumel-Eisner Neuromedical Institute

Miami Beach, Florida, United States

Site Status

Palm Beach Neurological Center

Palm Beach Gardens, Florida, United States

Site Status

Research Site

Port Charlotte, Florida, United States

Site Status

Suncoast Neuroscience Associates

St. Petersburg, Florida, United States

Site Status

Meridien Research

St. Petersburg, Florida, United States

Site Status

Axiom Clinical Research of Florida

Tampa, Florida, United States

Site Status

Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute

Tampa, Florida, United States

Site Status

Premiere Research Institute

West Palm Beach, Florida, United States

Site Status

DeKalb Neurology Associates

Atlanta, Georgia, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Mercer University

Atlanta, Georgia, United States

Site Status

Rush Alzheimers Disease Center

Chicago, Illinois, United States

Site Status

University of Illinois at Chicago

Chicago, Illinois, United States

Site Status

Radiant Research

Hoffman Estates, Illinois, United States

Site Status

Southern Illinois School of Medicine

Springfield, Illinois, United States

Site Status

Fort Wayne Neurological Center

Fort Wayne, Indiana, United States

Site Status

Center for Alzheimers Disease and Related Disorders

Indianapolis, Indiana, United States

Site Status

Agewell

Indianapolis, Indiana, United States

Site Status

Louisiana State University Health Sciences Cntr - Dept of Psychiatry

New Orleans, Louisiana, United States

Site Status

J. Gary Booker, M.D., APMC

Shreveport, Louisiana, United States

Site Status

St. Louis University Medical Center

St Louis, Missouri, United States

Site Status

University of Nevada

Las Vegas, Nevada, United States

Site Status

Mid Atlantic Geriatric Association

Ocean Township, New Jersey, United States

Site Status

Meridian Institue for Aging

Paterson, New Jersey, United States

Site Status

St. Francis Medical Center

Trenton, New Jersey, United States

Site Status

Upstate Clinical Reserach, LLC

Albany, New York, United States

Site Status

Upstate Neurology Consults, LLP

Albany, New York, United States

Site Status

Neurological Associates of Albany

Albany, New York, United States

Site Status

Neurobehavioral Research Inc.

Lawrence, New York, United States

Site Status

Eastside Comprehensive Medical Services

New York, New York, United States

Site Status

Global Reserach & Consulting

Olean, New York, United States

Site Status

Monroe Community Hospital

Rochester, New York, United States

Site Status

Behavioral Medical Research

Staten Island, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Metrohealth Medical Center

Cleveland, Ohio, United States

Site Status

Ohio State University Hospital

Columbus, Ohio, United States

Site Status

Infinity Research Group, LLC

Oklahoma City, Oklahoma, United States

Site Status

Clinical Pharmaceutical Trials

Tulsa, Oklahoma, United States

Site Status

Medford Neurological and Spine Clinic

Medford, Oregon, United States

Site Status

Summit Research Network

Portland, Oregon, United States

Site Status

Oregon Health and Science University

Portland, Oregon, United States

Site Status

Westmoreland Neurology Associates, Inc.

Greensburg, Pennsylvania, United States

Site Status

University of PA, Section Geriatric Psychiatry

Philadelphia, Pennsylvania, United States

Site Status

Alzheimer Disease Research Center, Univ of Pittsburg

Pittsburgh, Pennsylvania, United States

Site Status

Miriam Hospital

Providence, Rhode Island, United States

Site Status

Medical University of South Carolina, Alzheimers Research and Clinical Programs

North Charleston, South Carolina, United States

Site Status

Claghorn Lesem Research Clinic

Bellaire, Texas, United States

Site Status

Memory Research Unit, Univ of Texas Southwest Med Ctr at Dallas

Dallas, Texas, United States

Site Status

Radiant Research San Antonio

San Antonio, Texas, United States

Site Status

Neurological Consultants, PC

Bennington, Vermont, United States

Site Status

Innovative Clinical Research Center

Alexandria, Virginia, United States

Site Status

Medical College of Wisconsin, Department of Neurology

Milwaukee, Wisconsin, United States

Site Status

Independent Psychiatric Consultants

Waukesha, Wisconsin, United States

Site Status

Inova Health Research, Inc.

Kelowna, British Columbia, Canada

Site Status

University of British Columbia Hospital

Vancouver, British Columbia, Canada

Site Status

Davidson Memory Clinic

Moncton, New Brunswick, Canada

Site Status

Parkwood Hospital, Geriatric Medicine

London, Ontario, Canada

Site Status

SCO Health Centre

Ottawa, Ontario, Canada

Site Status

Toronto Memory Program

Toronto, Ontario, Canada

Site Status

Hopital Maisonneuve-Rosemont

Montreal, Quebec, Canada

Site Status

Pasqua Hospital

Regina, Saskatchewan, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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ONO-2506POU010

Identifier Type: -

Identifier Source: org_study_id

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