AzTrials
AzTrials

Alzheimer's DiseasePhase 2NCT00083421

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

A Phase 2 study testing ONO-2506PO in people with Alzheimer's Disease, run by Ono Pharma USA Inc at 87 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 90 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
ONO-2506PO
How many people
647 participants
Where
87 sitesin 2 countries
Study dates
Jun 2004to Jul 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

87 sites in 2 countries.

87 sites in 2 countries

United States79 sites

  • Upstate Clinical Reserach, LLC

    Albany, New York, 12205

  • Upstate Neurology Consults, LLP

    Albany, New York, 12205

  • Neurological Associates of Albany

    Albany, New York, 12208

  • Innovative Clinical Research Center

    Alexandria, Virginia, 22304

  • DeKalb Neurology Associates

    Atlanta, Georgia, 30033

  • Emory University

    Atlanta, Georgia, 30329

  • Mercer University

    Atlanta, Georgia, 30341

  • Claghorn Lesem Research Clinic

    Bellaire, Texas, 77401

  • Neurological Consultants, PC

    Bennington, Vermont, 05201

  • Kirkland Clinic

    Birmingham, Alabama, 35233

  • Alzheimers Disease Research Center

    Birmingham, Alabama, 35294

  • Baumel-Eisner Neuromedical Institute

    Boca Raton, Florida, 33431

  • Rush Alzheimers Disease Center

    Chicago, Illinois, 60612

  • University of Illinois at Chicago

    Chicago, Illinois, 60612

  • Metrohealth Medical Center

    Cleveland, Ohio, 44109

  • Ohio State University Hospital

    Columbus, Ohio, 43210

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

    Dallas, Texas, 75390

  • Research Center for Clinical Studies, Inc.

    Darien, Connecticut, 06820

  • Radiant Research

    Denver, Colorado, 80212

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Neurologic Consultants

    Fort Lauderdale, Florida, 33308

  • Baumel-Eisner Neuromedical Institute

    Fort Lauderdale, Florida, 33321

  • Fort Wayne Neurological Center

    Fort Wayne, Indiana, 46805

  • Margolin Brain Institute

    Fresno, California, 93720

  • Gainsville Open MRI

    Gainsville, Florida, 32607

  • Westmoreland Neurology Associates, Inc.

    Greensburg, Pennsylvania, 15601

  • GAP Clinical Care & Research Center

    Hamden, Connecticut, 06518

  • Berma Research Group

    Hialeah, Florida, 33016

  • Radiant Research

    Hoffman Estates, Illinois, 60194

  • Center for Alzheimers Disease and Related Disorders

    Indianapolis, Indiana, 46202

  • Agewell

    Indianapolis, Indiana, 46260

  • University of Nevada

    Las Vegas, Nevada, 89102

  • Neurobehavioral Research Inc.

    Lawrence, New York, 11559

  • Medford Neurological and Spine Clinic

    Medford, Oregon, 97504

  • Pivotal Research Center

    Mesa, Arizona, 85210

  • Miami Jewish and Hospital for the Aged

    Miami, Florida, 33137

  • Baumel-Eisner Neuromedical Institute

    Miami Beach, Florida, 33154

  • Medical College of Wisconsin, Department of Neurology

    Milwaukee, Wisconsin, 53226

  • Louisiana State University Health Sciences Cntr - Dept of Psychiatry

    New Orleans, Louisiana, 70112

  • Eastside Comprehensive Medical Services

    New York, New York, 10021

  • Medical University of South Carolina, Alzheimers Research and Clinical Programs

    North Charleston, South Carolina, 29406

  • Mid Atlantic Geriatric Association

    Ocean Township, New Jersey, 07712

  • Infinity Research Group, LLC

    Oklahoma City, Oklahoma, 73103

  • Global Reserach & Consulting

    Olean, New York, 14760

  • UCI Medical Center Neuropsychiatric Center

    Orange, California, 92868

  • Pacific Neuroscience Medical Group

    Oxnard, California, 93030

  • Palm Beach Neurological Center

    Palm Beach Gardens, Florida, 33410

  • Meridian Institue for Aging

    Paterson, New Jersey, 08759

  • University of PA, Section Geriatric Psychiatry

    Philadelphia, Pennsylvania, 19104

  • HOPE Research Institute

    Phoenix, Arizona, 85032

  • Alzheimer Disease Research Center, Univ of Pittsburg

    Pittsburgh, Pennsylvania, 15213

  • Research Site

    Port Charlotte, Florida, 33952

  • Summit Research Network

    Portland, Oregon, 97223

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Miriam Hospital

    Providence, Rhode Island, 02906

  • The Southwest Institute for Clinical Research, Inc

    Rancho Mirage, California, 92270

  • Hamid Rabiee, MD

    Redding, California, 96001

  • Monroe Community Hospital

    Rochester, New York, 14620

  • Radiant Research San Antonio

    San Antonio, Texas, 78229

  • Alzheimers Disease Research Center, Univ of CA, San Diego

    San Diego, California, 92037

  • Pacific Research Network

    San Diego, California, 92103

  • San Francisco Clinical Research Center

    San Francisco, California, 94109

  • Apex Research Institute

    Santa Ana, California, 92705

  • Pacific Neuroscience Medical Group

    Santa Barbara, California, 93101

  • Neurological Research Institute

    Santa Monica, California, 90404

  • J. Gary Booker, M.D., APMC

    Shreveport, Louisiana, 71101

  • Southern Illinois School of Medicine

    Springfield, Illinois, 62702

  • St. Louis University Medical Center

    St Louis, Missouri, 63104

  • Suncoast Neuroscience Associates

    St. Petersburg, Florida, 33701

  • Meridien Research

    St. Petersburg, Florida, 33709

  • Behavioral Medical Research

    Staten Island, New York, 10305

  • Sun Health Research Institute

    Sun City, Arizona, 85351

  • Axiom Clinical Research of Florida

    Tampa, Florida, 33609

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

    Tampa, Florida, 33647

  • St. Francis Medical Center

    Trenton, New Jersey, 08629

  • University of Arizona

    Tucson, Arizona, 85724

  • Clinical Pharmaceutical Trials

    Tulsa, Oklahoma, 74104

  • Independent Psychiatric Consultants

    Waukesha, Wisconsin, 53188

  • Premiere Research Institute

    West Palm Beach, Florida, 33407

Other trials in United States

Canada8 sites

  • Inova Health Research, Inc.

    Kelowna, British Columbia, V1W 4V5

  • Parkwood Hospital, Geriatric Medicine

    London, Ontario, N6C 5J1

  • Davidson Memory Clinic

    Moncton, New Brunswick, E1C 4B7

  • Hopital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

  • SCO Health Centre

    Ottawa, Ontario, KIN 5C8

  • Pasqua Hospital

    Regina, Saskatchewan, S4T 1A5

  • Toronto Memory Program

    Toronto, Ontario, M3B 2W7

  • University of British Columbia Hospital

    Vancouver, British Columbia, V6T 2B5

Other trials in Canada

About this study

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.

Being tested
ONO-2506PO
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ONO-2506PODrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognitive Function Scale

  2. Global Function Scale

Secondary outcomes (2)

  1. ADL Scale

  2. Psychiatric Symptom Scale

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2004 (estimated)
  2. Study startJun 2004
  3. Study completionJul 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
647 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00083421
Sponsor's protocol ID
ONO-2506POU010
Status last verified
Jun 2012
First submitted
24 May 2004
Last updated
13 Jun 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ONO-2506PO in people with Alzheimer's Disease, run by Ono Pharma USA Inc at 87 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive Function Scale. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00083421.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2012.

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