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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00087724
Recruitment Status : Terminated
First Posted : July 14, 2004
Last Update Posted : June 7, 2012
Astellas Pharma US, Inc.
Information provided by:
Astellas Pharma Inc

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: FK962 Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 510 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : July 2004
Actual Study Completion Date : September 2006

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00087724

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Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma US, Inc.
Study Director: Use Central Contact Astellas Pharma US, Inc. Identifier: NCT00087724     History of Changes
Other Study ID Numbers: 03-0-189
First Posted: July 14, 2004    Key Record Dates
Last Update Posted: June 7, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders