A Randomized Study to Evaluate FK962 in Subjects With Mild to Moderate Alzheimer's Disease

June 6, 2012 updated by: Astellas Pharma Inc

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 2 Study to Evaluate the Safety and Efficacy of FK962 in Subjects With Mild to Moderate Alzheimer's Disease

The purpose of this study is to evaluate the safety and efficacy of five fixed dosage levels of FK962 or placebo for 24 weeks in subjects with mild to moderate Alzheimer's disease. Patient visits are every six weeks with limited efficacy measurements at week 6 and 18.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

510

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, V1Y3G8
        • Investigational Site
      • Penticton, British Columbia, Canada, V2A5C8
        • Investigational Site
      • Victoria, British Columbia, Canada, V8T5G1
        • Investigational Site
    • Nova Scotia
      • Sydney, Nova Scotia, Canada, B1P1C6
        • Investigational Site
    • Ontario
      • Barrie, Ontario, Canada, L4M4S5
        • Investigational Site
      • North York, Ontario, Canada, M2J5A3
        • Investigational Site
      • North York, Ontario, Canada, M6M3C5
        • Investigational Site
      • Ottawa, Ontario, Canada, K1G 4C3
        • Investigational Site
      • Sudbury, Ontario, Canada, P3E6B4
        • Investigational Site
      • Toronto, Ontario, Canada, M6M3Z5
        • Investigational Site
      • Willowdale, Ontario, Canada, M2K2Z3
        • Investigational Site
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4T1A5
        • Investigational Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Investigational Site
      • Phoenix, Arizona, United States, 85013
        • Investigational Site
      • Sun City, Arizona, United States, 85351
      • Tucson, Arizona, United States, 85724
        • Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Investigational Site
      • Little Rock, Arkansas, United States, 72205
        • Investigational Site
    • California
      • Fresno, California, United States, 93720
        • Investigational Site
      • Irvine, California, United States, 92618
        • Investigational Site
      • Orange, California, United States, 92656
        • Investigational Site
      • San Francisco, California, United States, 94115
        • Investigational Site
      • Sherman Oaks, California, United States, 91403
        • Investigational Site
      • Torrance, California, United States, 90505
        • Investigational Site
    • Colorado
      • Denver, Colorado, United States, 80249
        • Investigative Site
      • Denver, Colorado, United States, 80262
        • Investigational Site
    • Connecticut
      • Darien, Connecticut, United States, 06820
        • Investigational Site
      • Hamden, Connecticut, United States, 06518
      • Hamden, Connecticut, United States, 06518
        • Investigational Site
      • Stamford, Connecticut, United States, 06902
        • Investigational Site
    • Florida
      • Fort Myers, Florida, United States, 33912
        • Investigational Site
      • Hialeah, Florida, United States, 33016
        • Investigational Site
      • Hollywood, Florida, United States, 33021
        • Investigational Site
      • Miami, Florida, United States, 33176
        • Investigational Site
      • North Miami, Florida, United States, 33161
        • Investigational Site
      • Ocala, Florida, United States, 34471
        • Investigational Site
      • Port Charlotte, Florida, United States, 33952
        • Investigational Site
      • Sarasota, Florida, United States, 34243
        • Investigational Site
      • Sebring, Florida, United States, 33872
        • Investigational Site
      • Tampa, Florida, United States, 33613
        • Investigational Site
      • West Palm Beach, Florida, United States, 33407
    • Georgia
      • Snellville, Georgia, United States, 30078
      • Snellville, Georgia, United States, 30078
        • Investigational Site
    • Illinois
      • Elk Grove, Illinois, United States, 60007
        • Investigational Site
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21208
    • Massachusetts
      • Newton, Massachusetts, United States, 02459
        • Investigational Site
    • Michigan
      • Livonia, Michigan, United States, 48152
    • Mississippi
      • Hattiesburg, Mississippi, United States, 32401
    • Missouri
      • St. Louis, Missouri, United States, 63128
        • Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • Investigational Site
    • New Jersey
      • Long Branch, New Jersey, United States, 07740
        • Investigational Site
      • Manchester, New Jersey, United States, 08759
        • Investigational Site
      • Piscataway, New Jersey, United States, 08855
        • Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Investigational Site
    • New York
      • Albany, New York, United States, 12208
        • Investigational Site
      • Buffalo, New York, United States, 14221
        • Investigational Site
      • Lawrence, New York, United States, 11559
        • Investigational Site
      • New York, New York, United States, 10021
        • Investigational Site
      • White Plains, New York, United States, 10605
        • Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
    • Ohio
      • Centerville, Ohio, United States, 45459
        • Investigational Site
      • Columbus, Ohio, United States, 43210
        • Investigational Site
      • Dayton, Ohio, United States, 45408
      • Dayton, Ohio, United States, 45415
        • Investigational Site
      • Toledo, Ohio, United States, 43623
        • Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Investigational Site
      • Tulsa, Oklahoma, United States, 74104
        • Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Investigational Site
      • Medford, Oregon, United States, 97504
        • Investigational Site
    • Pennsylvania
      • Bala Cynwyd, Pennsylvania, United States, 19004
        • Investigational Site
      • Jenkintown, Pennsylvania, United States, 19046
        • Investigational Site
    • Rhode Island
      • Pawtucket, Rhode Island, United States, 02860
        • Investigational Site
    • Tennessee
      • Johnson City, Tennessee, United States, 37601
        • Investigational Site
      • Nashville, Tennessee, United States, 37203
        • Investigational Site
    • Texas
      • Houston, Texas, United States, 77063
        • Investigational Site
      • San Antonio, Texas, United States, 78229
        • Investigational Site
      • Wichita Falls, Texas, United States, 76309
        • Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84121
        • Investigational Site
    • Vermont
      • Bennington, Vermont, United States, 05201
        • Investigational Site
      • Burlington, Vermont, United States, 05401
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53227
        • Investigational Site

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:

  • Subject satisfies the criteria for the clinical diagnosis of probable AD
  • Subject has a score =< 4 on the Modified Hachinski Ischemia Scale at the screening visit

Exclusion Criteria:

  • Subject has history or evidence of significant neurologic disease other than AD
  • Subject has a history of stroke
  • Subject has been treated for schizophrenia or recurrent mood disorder within the previous three years
  • Subject has a hematologic or solid malignancy diagnosed within five years prior to study entry
  • Subject has medically unstable COPD or asthma
  • Subject has end stage CHF (NYHA Class III or IV) or unstable angina
  • Subject has evidence of significant renal insufficiency
  • Subject has insulin-dependent diabetes mellitus or HbA1C>8.5% at screening

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 Assignment
  • Masking: Double

Collaborators and Investigators

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

Sponsor

Astellas Pharma Inc

Collaborators

Astellas Pharma US, 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

July 1, 2004

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

July 12, 2004

First Submitted That Met QC Criteria

July 13, 2004

First Posted (Estimate)

July 14, 2004

Study Record Updates

Last Update Posted (Estimate)

June 7, 2012

Last Update Submitted That Met QC Criteria

June 6, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-0-189

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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