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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00087724

Enrollment

510

Registered

2004-07-14

Start date

2004-07-31

Completion date

2006-09-30

Last updated

2012-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

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 every six weeks with limited efficacy measurements at week 6 and 18.

Interventions

DRUGFK962

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

50 Years to 90 Years

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

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026