Status:
TERMINATED
A Randomized Study to Evaluate FK962 in Subjects With Mild to Moderate Alzheimer's Disease
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Astellas Pharma US, Inc.
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50-90 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
510 Patients enrolled
Trial Details
Trial ID
NCT00087724
Start Date
July 1 2004
End Date
September 1 2006
Last Update
June 7 2012
Active Locations (84)
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1
Investigational Site
Phoenix, Arizona, United States, 85013
2
Investigational Site
Phoenix, Arizona, United States, 85032
3
Sun City, Arizona, United States, 85351
4
Investigational Site
Tucson, Arizona, United States, 85724