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

This study has been terminated.

First Received: July 12, 2004 Last Updated: July 20, 2006 History of Changes

Sponsors and Collaborators:	Astellas Pharma Inc Astellas Pharma US, Inc.
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00087724

Purpose

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 II

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Astellas Pharma Inc:

Estimated Enrollment:	510
Study Start Date:	July 2004

Eligibility

Ages Eligible for Study:	50 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00087724

Show 86 Study Locations

Sponsors and Collaborators

Astellas Pharma Inc

Astellas Pharma US, Inc.

Investigators

Study Director:

Use Central Contact

Astellas Pharma US, Inc.

More Information

No publications provided

Study ID Numbers:	03-0-189
Study First Received:	July 12, 2004
Last Updated:	July 20, 2006
ClinicalTrials.gov Identifier:	NCT00087724 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases

Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases

Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on May 07, 2009