CompletedPhase 3

Cholesterol Lowering Agent to Slow Progression (CLASP) of Alzheimer's Disease Study

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial of Simvastatin to Slow the Progression of Alzheimer's Disease

Lead sponsor

National Institute on Aging (NIA)

Asset

Simvastatin

Listed sites

Recruiting sites

Enrollment

400

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 12-26

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

SecondaryADC-015-LL

Org study IDIA0038

NCT IDNCT00053599

Timeline

Milestones

Study start2002-12 (month precision)

Study first posted2003-02-04estimated

Primary completion2007-10actual (month precision)

Study completion2007-10actual (month precision)

Last update posted2009-07-28estimated

Assets

Drug assets

Simvastatin

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Mild to moderate patients with AD who are free of life-threatening disease and who do not require lipid-lowering treatment according to current guidelines.

•NINCDS/ADRDA criteria for probable AD.

•Mini-Mental-State-Exam (MMSE) score between 12 and 26.

•Stable medical condition for 3 months prior to the screening visit.

•Age greater than or equal to 50 years, and no upper age limit.

•Lives in a community dwelling, not in a nursing home.

•Stable doses of (non-excluded) medications with central nervous system activity for 4 weeks prior to the screening visit.

•Physical condition acceptable for the study as confirmed by medical history, physical exam, neurologic exam and clinical laboratory tests.

•Informant/study partner available and willing to accompany participant to all scheduled visits and complete informant-based assessments and to supervise administration of study medications.

•Fluent in English or Spanish.

•Modified Hachinski is less than or equal to 4

Exclusion criteria

•Coronary heart disease (CHD) including angina, or peripheral vascular disease including symptomatic carotid artery disease, or stroke or TIA, as these individuals are likely to require treatment with lipid-lowering drugs.

•Serious renal disease.

•Uncontrolled diabetes.

•Triglycerides are greater than 500 mg/dL.

•LDL-Cholesterol below 80 mg/dL

•Upper limit for the National Cholesterol Education Program (NCEP) guidelines for LDL-Cholesterol is 130-190 mg/dL, depending on age and other cardiovascular risk factors.

•Other indication for the need to treat with lipid-lowering drug.

•Active liver disease or persistent elevation in serum transaminase.

•Active neoplastic disease (skin tumors other than melanoma are not exclusionary; subjects with stable prostate cancer may be included at the discretion of the Project Director).

•Use of another investigational agent within 2 months of the screening visit.

•History of clinically significant stroke.

•Current evidence or history in the past 2 years of seizures, head injury with loss of consciousness and/or immediate confusion after the injury.

•Current DSM-IV criteria based diagnosis for major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse.

•Blindness, deafness, language difficulties or any other disability which may prevent the subject from participating or cooperating in the protocol.

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.

Publications (3)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.