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

June 12, 2012 updated by: Ono Pharma USA Inc
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

647

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada, V1W 4V5
        • Inova Health Research, Inc.
      • Vancouver, British Columbia, Canada, V6T 2B5
        • University of British Columbia Hospital
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 4B7
        • Davidson Memory Clinic
    • Ontario
      • London, Ontario, Canada, N6C 5J1
        • Parkwood Hospital, Geriatric Medicine
      • Ottawa, Ontario, Canada, KIN 5C8
        • SCO Health Centre
      • Toronto, Ontario, Canada, M3B 2W7
        • Toronto Memory Program
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Hôpital Maisonneuve-Rosemont
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T 1A5
        • Pasqua Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Kirkland Clinic
      • Birmingham, Alabama, United States, 35294
        • Alzheimers Disease Research Center
    • Arizona
      • Mesa, Arizona, United States, 85210
        • Pivotal Research Center
      • Phoenix, Arizona, United States, 85032
        • Hope Research Institute
      • Sun City, Arizona, United States, 85351
        • Sun Health Research Institute
      • Tucson, Arizona, United States, 85724
        • University of Arizona
    • California
      • Fresno, California, United States, 93720
        • Margolin Brain Institute
      • Orange, California, United States, 92868
        • UCI Medical Center Neuropsychiatric Center
      • Oxnard, California, United States, 93030
        • Pacific Neuroscience Medical Group
      • Rancho Mirage, California, United States, 92270
        • The Southwest Institute for Clinical Research, Inc
      • Redding, California, United States, 96001
        • Hamid Rabiee, MD
      • San Diego, California, United States, 92103
        • Pacific Research Network
      • San Diego, California, United States, 92037
        • Alzheimers Disease Research Center, Univ of CA, San Diego
      • San Francisco, California, United States, 94109
        • San Francisco Clinical Research Center
      • Santa Ana, California, United States, 92705
        • Apex Research Institute
      • Santa Barbara, California, United States, 93101
        • Pacific Neuroscience Medical Group
      • Santa Monica, California, United States, 90404
        • Neurological Research Institute
    • Colorado
      • Denver, Colorado, United States, 80212
        • Radiant Research
    • Connecticut
      • Darien, Connecticut, United States, 06820
        • Research Center for Clinical Studies, Inc.
      • Hamden, Connecticut, United States, 06518
        • GAP Clinical Care & Research Center
    • Florida
      • Boca Raton, Florida, United States, 33431
        • Baumel-Eisner Neuromedical Institute
      • Ft. Lauderdale, Florida, United States, 33321
        • Baumel-Eisner Neuromedical Institute
      • Ft. Lauderdale, Florida, United States, 33308
        • Neurologic Consultants
      • Gainsville, Florida, United States, 32607
        • Gainsville Open MRI
      • Hialeah, Florida, United States, 33016
        • Berma Research Group
      • Miami, Florida, United States, 33137
        • Miami Jewish and Hospital for the Aged
      • Miami Beach, Florida, United States, 33154
        • Baumel-Eisner Neuromedical Institute
      • Palm Beach Gardens, Florida, United States, 33410
        • Palm Beach Neurological Center
      • Port Charlotte, Florida, United States, 33952
        • Research Site
      • St. Petersburg, Florida, United States, 33709
        • Meridien Research
      • St. Petersburg, Florida, United States, 33701
        • Suncoast Neuroscience Associates
      • Tampa, Florida, United States, 33609
        • Axiom Clinical Research of Florida
      • Tampa, Florida, United States, 33647
        • Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute
      • West Palm Beach, Florida, United States, 33407
        • Premiere Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Emory University
      • Atlanta, Georgia, United States, 30033
        • DeKalb Neurology Associates
      • Atlanta, Georgia, United States, 30341
        • Mercer University
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago
      • Chicago, Illinois, United States, 60612
        • Rush Alzheimers Disease Center
      • Hoffman Estates, Illinois, United States, 60194
        • Radiant Research
      • Springfield, Illinois, United States, 62702
        • Southern Illinois School of Medicine
    • Indiana
      • Fort Wayne, Indiana, United States, 46805
        • Fort Wayne Neurological Center
      • Indianapolis, Indiana, United States, 46260
        • Agewell
      • Indianapolis, Indiana, United States, 46202
        • Center for Alzheimers Disease and Related Disorders
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Louisiana State University Health Sciences Cntr - Dept of Psychiatry
      • Shreveport, Louisiana, United States, 71101
        • J. Gary Booker, M.D., APMC
    • Missouri
      • St. Louis, Missouri, United States, 63104
        • St. Louis University Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • University of Nevada
    • New Jersey
      • Manchester, New Jersey, United States, 08759
        • Meridian Institue for Aging
      • Ocean Township, New Jersey, United States, 07712
        • Mid Atlantic Geriatric Association
      • Trenton, New Jersey, United States, 08629
        • St. Francis Medical Center
    • New York
      • Albany, New York, United States, 12208
        • Neurological Associates of Albany
      • Albany, New York, United States, 12205
        • Upstate Clinical Reserach, LLC
      • Albany, New York, United States, 12205
        • Upstate Neurology Consults, LLP
      • Lawrence, New York, United States, 11559
        • Neurobehavioral Research Inc.
      • New York, New York, United States, 10021
        • Eastside Comprehensive Medical Services
      • Olean, New York, United States, 14760
        • Global Reserach & Consulting
      • Rochester, New York, United States, 14620
        • Monroe Community Hospital
      • Staten Island, New York, United States, 10305
        • Behavioral Medical Research
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
      • Columbus, Ohio, United States, 43210
        • Ohio State University Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Infinity Research Group, LLC
      • Tulsa, Oklahoma, United States, 74104
        • Clinical Pharmaceutical Trials
    • Oregon
      • Medford, Oregon, United States, 97504
        • Medford Neurological and Spine Clinic
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
      • Portland, Oregon, United States, 97223
        • Summit Research Network
    • Pennsylvania
      • Greensburg, Pennsylvania, United States, 15601
        • Westmoreland Neurology Associates, Inc.
      • Philadelphia, Pennsylvania, United States, 19104
        • University of PA, Section Geriatric Psychiatry
      • Pittsburg, Pennsylvania, United States, 15213
        • Alzheimer Disease Research Center, Univ of Pittsburg
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Miriam Hospital
    • South Carolina
      • North Charleston, South Carolina, United States, 29406
        • Medical University of South Carolina, Alzheimers Research and Clinical Programs
    • Texas
      • Bellaire, Texas, United States, 77401
        • Claghorn Lesem Research Clinic
      • Dallas, Texas, United States, 75390
        • Memory Research Unit, Univ of Texas Southwest Med Ctr at Dallas
      • San Antonio, Texas, United States, 78229
        • Radiant Research San Antonio
    • Vermont
      • Bennington, Vermont, United States, 05201
        • Neurological Consultants, PC
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • Innovative Clinical Research Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin, Department of Neurology
      • Waukesha, Wisconsin, United States, 53188
        • Independent Psychiatric Consultants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Cognitive Function Scale
Global Function Scale

Secondary Outcome Measures

Outcome Measure
ADL Scale
Psychiatric Symptom Scale

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ono Pharma USA Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Study Completion (ACTUAL)

July 1, 2007

Study Registration Dates

First Submitted

May 24, 2004

First Submitted That Met QC Criteria

June 17, 2004

First Posted (ESTIMATE)

June 18, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

June 13, 2012

Last Update Submitted That Met QC Criteria

June 12, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONO-2506POU010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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