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

Stopped early · Phase 2

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT00087724

Run by

Astellas Pharma Inc

People needed

510

Starts

2004-07-01

Expected to finish

2006-09-01

Last updated by the study team

2012-06-07

Who can join

Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Investigational Site — Phoenix, Arizona, United States
• Study site — Sun City, Arizona, United States
• Investigational Site — Tucson, Arizona, United States
• Investigational Site — Little Rock, Arkansas, United States
• Investigational Site — Little Rock, Arkansas, United States
• Investigational Site — Fresno, California, United States
• Investigational Site — Irvine, California, United States
• Investigational Site — Orange, California, United States
• Investigational Site — San Francisco, California, United States
• Investigational Site — Sherman Oaks, California, United States
• Investigational Site — Torrance, California, United States
• Investigative Site — Denver, Colorado, United States
• Investigational Site — Denver, Colorado, United States
• Investigational Site — Darien, Connecticut, United States
• Investigational Site — Hamden, Connecticut, United States
• Study site — Hamden, Connecticut, United States
• Investigational Site — Stamford, Connecticut, United States
• Investigational Site — Fort Myers, Florida, United States
• Investigational Site — Hialeah, Florida, United States
• Investigational Site — Hollywood, Florida, United States
• Investigational Site — Miami, Florida, United States
• Investigational Site — North Miami, Florida, United States
• Investigational Site — Ocala, Florida, United States
• Investigational Site — Port Charlotte, Florida, United States
• Investigational Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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