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

Astellas

Status and phase

Terminated

Phase 2

Conditions

Alzheimer's Disease

Treatments

Drug: FK962

Study type

Interventional

Funder types

Industry

Identifiers

NCT00087724

03-0-189

Details and patient eligibility

About

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.

Sex

All

Ages

50 to 90 years old

Volunteers

No Healthy Volunteers

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