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

This study has been terminated.
Astellas Pharma US, Inc.
Information provided by:
Astellas Pharma Inc Identifier:
First received: July 12, 2004
Last updated: June 6, 2012
Last verified: June 2012

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 Intervention Phase
Alzheimer's Disease
Drug: FK962
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Estimated Enrollment: 510
Study Start Date: July 2004
Study Completion Date: September 2006

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00087724

  Show 84 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma US, Inc.
Study Director: Use Central Contact Astellas Pharma US, Inc.
  More Information

No publications provided Identifier: NCT00087724     History of Changes
Other Study ID Numbers: 03-0-189
Study First Received: July 12, 2004
Last Updated: June 6, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies processed this record on November 25, 2014