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

NCT ID: NCT00087724

Last Updated: 2012-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

510 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2006-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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FK962

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma US, Inc.

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Principal Investigators

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Use Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma US, Inc.

Locations

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Investigational Site

Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Sun City, Arizona, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Little Rock, Arkansas, United States

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Fresno, California, United States

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Irvine, California, United States

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Orange, California, United States

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San Francisco, California, United States

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Sherman Oaks, California, United States

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Torrance, California, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Darien, Connecticut, United States

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Hamden, Connecticut, United States

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Hamden, Connecticut, United States

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Stamford, Connecticut, United States

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Fort Myers, Florida, United States

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Hialeah, Florida, United States

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Hollywood, Florida, United States

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Miami, Florida, United States

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North Miami, Florida, United States

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Ocala, Florida, United States

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Port Charlotte, Florida, United States

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Sarasota, Florida, United States

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Sebring, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

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Snellville, Georgia, United States

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Snellville, Georgia, United States

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Elk Grove, Illinois, United States

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Wichita, Kansas, United States

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New Orleans, Louisiana, United States

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Baltimore, Maryland, United States

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Newton, Massachusetts, United States

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Livonia, Michigan, United States

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Hattiesburg, Mississippi, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Long Branch, New Jersey, United States

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Paterson, New Jersey, United States

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Piscataway, New Jersey, United States

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Albuquerque, New Mexico, United States

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Albany, New York, United States

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Buffalo, New York, United States

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Lawrence, New York, United States

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New York, New York, United States

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White Plains, New York, United States

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Charlotte, North Carolina, United States

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Centerville, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Dayton, Ohio, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Eugene, Oregon, United States

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Medford, Oregon, United States

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Bala-Cynwyd, Pennsylvania, United States

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Jenkintown, Pennsylvania, United States

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Pawtucket, Rhode Island, United States

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Johnson City, Tennessee, United States

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Nashville, Tennessee, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Wichita Falls, Texas, United States

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Salt Lake City, Utah, United States

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Bennington, Vermont, United States

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Burlington, Vermont, United States

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Norfolk, Virginia, United States

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Milwaukee, Wisconsin, United States

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Kelowna, British Columbia, Canada

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Penticton, British Columbia, Canada

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Victoria, British Columbia, Canada

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Sydney, Nova Scotia, Canada

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Barrie, Ontario, Canada

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Greater Sudbury, Ontario, Canada

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North York, Ontario, Canada

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North York, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Willowdale, Ontario, Canada

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Regina, Saskatchewan, Canada

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Countries

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United States Canada

Other Identifiers

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03-0-189

Identifier Type: -

Identifier Source: org_study_id

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