NCT00083421

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
647

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2004

Typical duration for phase_2

Geographic Reach
2 countries

87 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2004

Completed
8 days until next milestone

Study Start

First participant enrolled

June 1, 2004

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 18, 2004

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

June 13, 2012

Status Verified

June 1, 2012

First QC Date

May 24, 2004

Last Update Submit

June 12, 2012

Conditions

Outcome Measures

Primary Outcomes (2)

  • Cognitive Function Scale

  • Global Function Scale

Secondary Outcomes (2)

  • ADL Scale

  • Psychiatric Symptom Scale

Interventions

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Serious systemic disease that may preclude survival to study completion
  • Other illnesses that may include dementive features

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (87)

Kirkland Clinic

Birmingham, Alabama, 35233, United States

Location

Alzheimers Disease Research Center

Birmingham, Alabama, 35294, United States

Location

Pivotal Research Center

Mesa, Arizona, 85210, United States

Location

HOPE Research Institute

Phoenix, Arizona, 85032, United States

Location

Sun Health Research Institute

Sun City, Arizona, 85351, United States

Location

University of Arizona

Tucson, Arizona, 85724, United States

Location

Margolin Brain Institute

Fresno, California, 93720, United States

Location

UCI Medical Center Neuropsychiatric Center

Orange, California, 92868, United States

Location

Pacific Neuroscience Medical Group

Oxnard, California, 93030, United States

Location

The Southwest Institute for Clinical Research, Inc

Rancho Mirage, California, 92270, United States

Location

Hamid Rabiee, MD

Redding, California, 96001, United States

Location

Alzheimers Disease Research Center, Univ of CA, San Diego

San Diego, California, 92037, United States

Location

Pacific Research Network

San Diego, California, 92103, United States

Location

San Francisco Clinical Research Center

San Francisco, California, 94109, United States

Location

Apex Research Institute

Santa Ana, California, 92705, United States

Location

Pacific Neuroscience Medical Group

Santa Barbara, California, 93101, United States

Location

Neurological Research Institute

Santa Monica, California, 90404, United States

Location

Radiant Research

Denver, Colorado, 80212, United States

Location

Research Center for Clinical Studies, Inc.

Darien, Connecticut, 06820, United States

Location

GAP Clinical Care & Research Center

Hamden, Connecticut, 06518, United States

Location

Baumel-Eisner Neuromedical Institute

Boca Raton, Florida, 33431, United States

Location

Neurologic Consultants

Fort Lauderdale, Florida, 33308, United States

Location

Baumel-Eisner Neuromedical Institute

Fort Lauderdale, Florida, 33321, United States

Location

Gainsville Open MRI

Gainsville, Florida, 32607, United States

Location

Berma Research Group

Hialeah, Florida, 33016, United States

Location

Miami Jewish and Hospital for the Aged

Miami, Florida, 33137, United States

Location

Baumel-Eisner Neuromedical Institute

Miami Beach, Florida, 33154, United States

Location

Palm Beach Neurological Center

Palm Beach Gardens, Florida, 33410, United States

Location

Research Site

Port Charlotte, Florida, 33952, United States

Location

Suncoast Neuroscience Associates

St. Petersburg, Florida, 33701, United States

Location

Meridien Research

St. Petersburg, Florida, 33709, United States

Location

Axiom Clinical Research of Florida

Tampa, Florida, 33609, United States

Location

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

Tampa, Florida, 33647, United States

Location

Premiere Research Institute

West Palm Beach, Florida, 33407, United States

Location

DeKalb Neurology Associates

Atlanta, Georgia, 30033, United States

Location

Emory University

Atlanta, Georgia, 30329, United States

Location

Mercer University

Atlanta, Georgia, 30341, United States

Location

Rush Alzheimers Disease Center

Chicago, Illinois, 60612, United States

Location

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Radiant Research

Hoffman Estates, Illinois, 60194, United States

Location

Southern Illinois School of Medicine

Springfield, Illinois, 62702, United States

Location

Fort Wayne Neurological Center

Fort Wayne, Indiana, 46805, United States

Location

Center for Alzheimers Disease and Related Disorders

Indianapolis, Indiana, 46202, United States

Location

Agewell

Indianapolis, Indiana, 46260, United States

Location

Louisiana State University Health Sciences Cntr - Dept of Psychiatry

New Orleans, Louisiana, 70112, United States

Location

J. Gary Booker, M.D., APMC

Shreveport, Louisiana, 71101, United States

Location

St. Louis University Medical Center

St Louis, Missouri, 63104, United States

Location

University of Nevada

Las Vegas, Nevada, 89102, United States

Location

Mid Atlantic Geriatric Association

Ocean Township, New Jersey, 07712, United States

Location

Meridian Institue for Aging

Paterson, New Jersey, 08759, United States

Location

St. Francis Medical Center

Trenton, New Jersey, 08629, United States

Location

Upstate Clinical Reserach, LLC

Albany, New York, 12205, United States

Location

Upstate Neurology Consults, LLP

Albany, New York, 12205, United States

Location

Neurological Associates of Albany

Albany, New York, 12208, United States

Location

Neurobehavioral Research Inc.

Lawrence, New York, 11559, United States

Location

Eastside Comprehensive Medical Services

New York, New York, 10021, United States

Location

Global Reserach & Consulting

Olean, New York, 14760, United States

Location

Monroe Community Hospital

Rochester, New York, 14620, United States

Location

Behavioral Medical Research

Staten Island, New York, 10305, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Metrohealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Ohio State University Hospital

Columbus, Ohio, 43210, United States

Location

Infinity Research Group, LLC

Oklahoma City, Oklahoma, 73103, United States

Location

Clinical Pharmaceutical Trials

Tulsa, Oklahoma, 74104, United States

Location

Medford Neurological and Spine Clinic

Medford, Oregon, 97504, United States

Location

Summit Research Network

Portland, Oregon, 97223, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Westmoreland Neurology Associates, Inc.

Greensburg, Pennsylvania, 15601, United States

Location

University of PA, Section Geriatric Psychiatry

Philadelphia, Pennsylvania, 19104, United States

Location

Alzheimer Disease Research Center, Univ of Pittsburg

Pittsburgh, Pennsylvania, 15213, United States

Location

Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Medical University of South Carolina, Alzheimers Research and Clinical Programs

North Charleston, South Carolina, 29406, United States

Location

Claghorn Lesem Research Clinic

Bellaire, Texas, 77401, United States

Location

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

Dallas, Texas, 75390, United States

Location

Radiant Research San Antonio

San Antonio, Texas, 78229, United States

Location

Neurological Consultants, PC

Bennington, Vermont, 05201, United States

Location

Innovative Clinical Research Center

Alexandria, Virginia, 22304, United States

Location

Medical College of Wisconsin, Department of Neurology

Milwaukee, Wisconsin, 53226, United States

Location

Independent Psychiatric Consultants

Waukesha, Wisconsin, 53188, United States

Location

Inova Health Research, Inc.

Kelowna, British Columbia, V1W 4V5, Canada

Location

University of British Columbia Hospital

Vancouver, British Columbia, V6T 2B5, Canada

Location

Davidson Memory Clinic

Moncton, New Brunswick, E1C 4B7, Canada

Location

Parkwood Hospital, Geriatric Medicine

London, Ontario, N6C 5J1, Canada

Location

SCO Health Centre

Ottawa, Ontario, KIN 5C8, Canada

Location

Toronto Memory Program

Toronto, Ontario, M3B 2W7, Canada

Location

Hopital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

Pasqua Hospital

Regina, Saskatchewan, S4T 1A5, Canada

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2004

First Posted

June 18, 2004

Study Start

June 1, 2004

Study Completion

July 1, 2007

Last Updated

June 13, 2012

Record last verified: 2012-06

Locations