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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ONO-2506PO
Sponsored by
Ono Pharma USA Inc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kirkland Clinic
  • Alzheimers Disease Research Center
  • Pivotal Research Center
  • HOPE Research Institute
  • Sun Health Research Institute
  • University of Arizona
  • Margolin Brain Institute
  • UCI Medical Center Neuropsychiatric Center
  • Pacific Neuroscience Medical Group
  • The Southwest Institute for Clinical Research, Inc
  • Hamid Rabiee, MD
  • Alzheimers Disease Research Center, Univ of CA, San Diego
  • Pacific Research Network
  • San Francisco Clinical Research Center
  • Apex Research Institute
  • Pacific Neuroscience Medical Group
  • Neurological Research Institute
  • Radiant Research
  • Research Center for Clinical Studies, Inc.
  • GAP Clinical Care & Research Center
  • Baumel-Eisner Neuromedical Institute
  • Neurologic Consultants
  • Baumel-Eisner Neuromedical Institute
  • Gainsville Open MRI
  • Berma Research Group
  • Baumel-Eisner Neuromedical Institute
  • Miami Jewish and Hospital for the Aged
  • Palm Beach Neurological Center
  • Research Site
  • Suncoast Neuroscience Associates
  • Meridien Research
  • Axiom Clinical Research of Florida
  • Johnnie B. Byrd Sr. Alzheimer's Center and Research Institute
  • Premiere Research Institute
  • DeKalb Neurology Associates
  • Emory University
  • Mercer University
  • Rush Alzheimers Disease Center
  • University of Illinois at Chicago
  • Radiant Research
  • Southern Illinois School of Medicine
  • Fort Wayne Neurological Center
  • Center for Alzheimers Disease and Related Disorders
  • Agewell
  • Louisiana State University Health Sciences Cntr - Dept of Psychiatry
  • J. Gary Booker, M.D., APMC
  • St. Louis University Medical Center
  • University of Nevada
  • Meridian Institue for Aging
  • Mid Atlantic Geriatric Association
  • St. Francis Medical Center
  • Upstate Clinical Reserach, LLC
  • Upstate Neurology Consults, LLP
  • Neurological Associates of Albany
  • Neurobehavioral Research Inc.
  • Eastside Comprehensive Medical Services
  • Global Reserach & Consulting
  • Monroe Community Hospital
  • Behavioral Medical Research
  • Duke University Medical Center
  • Metrohealth Medical Center
  • Ohio State University Hospital
  • Infinity Research Group, LLC
  • Clinical Pharmaceutical Trials
  • Medford Neurological and Spine Clinic
  • Summit Research Network
  • Oregon Health and Science University
  • Westmoreland Neurology Associates, Inc.
  • University of PA, Section Geriatric Psychiatry
  • Alzheimer Disease Research Center, Univ of Pittsburg
  • Miriam Hospital
  • Medical University of South Carolina, Alzheimers Research and Clinical Programs
  • Claghorn Lesem Research Clinic
  • Memory Research Unit, Univ of Texas Southwest Med Ctr at Dallas
  • Radiant Research San Antonio
  • Neurological Consultants, PC
  • Innovative Clinical Research Center
  • Medical College of Wisconsin, Department of Neurology
  • Independent Psychiatric Consultants
  • Inova Health Research, Inc.
  • University of British Columbia Hospital
  • Davidson Memory Clinic
  • Parkwood Hospital, Geriatric Medicine
  • SCO Health Centre
  • Toronto Memory Program
  • Hopital Maisonneuve-Rosemont
  • Pasqua Hospital

Outcomes

Primary Outcome Measures

Cognitive Function Scale
Global Function Scale

Secondary Outcome Measures

ADL Scale
Psychiatric Symptom Scale

Full Information

First Posted
May 24, 2004
Last Updated
June 12, 2012
Sponsor
Ono Pharma USA Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00083421
Brief Title
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

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ono Pharma USA Inc

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
647 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ONO-2506PO
Primary Outcome Measure Information:
Title
Cognitive Function Scale
Title
Global Function Scale
Secondary Outcome Measure Information:
Title
ADL Scale
Title
Psychiatric Symptom Scale

10. Eligibility

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

12. IPD Sharing Statement

Learn more about this trial

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

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