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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
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

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   (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
  Contacts and Locations
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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 Identifier: NCT00087724     History of Changes
Other Study ID Numbers: 03-0-189
Study First Received: July 12, 2004
Last Updated: June 6, 2012

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders processed this record on September 21, 2017