TerminatedPhase 2

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

Lead sponsor

Astellas Pharma Inc

Asset

FK962

Listed sites

Recruiting sites

Enrollment

510

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoint

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID03-0-189

NCT IDNCT00087724

Timeline

Milestones

Study start2004-07 (month precision)

Study first posted2004-07-14estimated

Study completion2006-09actual (month precision)

Last update posted2012-06-07estimated

Assets

Drug assets

FK962

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (0)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

No endpoints recorded for this trial.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.