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CompletedPhase 2

Lipitor as a Treatment for Alzheimer's Disease

Effect of the HMG-CoA Reductase Inhibitor Atorvastatin Calcium, Lipitor, in the Treatment of Alzheimer's Disease

Asset

Atorvastatin

Listed sites

1

Recruiting sites

-

Enrollment

98

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 12-28•Study partner/caregiver required•AD symptomatic therapy: stable

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 IDIA0031
NCT IDNCT00024531

Timeline

Milestones

Study start2000-10 (month precision)
Study first posted2001-09-20estimated
Study completion2004-08 (month precision)
Last update posted2006-11-09estimated

Assets

Drug assets

Atorvastatin

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Prior to participation in this study, each prospective study individual must sign an informed consent form.
•Diagnosis of probable or possible Alzheimer's disease according to NINDS-ADRDA and DSM-IV criteria.
•Not actively participating in another clinical drug trial.
•MMSE range 12-28 at entry.
•Hachinski Modified Ischemic score < or =4.
•Accompanied by appropriate caregiver who can aid in administration of medication and make assessments.
•Good general health as evidenced by physical, neurological and clinical laboratory examination.
•Education level > or = 9th grade or equivalent.
•Fluent in the English language.
•Reliable caregiver.
•Able to complete neuropsychological tests.
•Ambulatory.
•On stable doses of medications for the treatment of non-excluded medical conditions for four weeks prior to screening.
•Able to participate in all scheduled evaluations.
•Geriatric Depression Scale < or = 20.
•Not exceeding 400 IU of Vitamin E for 30 days.
•For patients currently taking donepezil, they must remain on a stable dose for at least three months. Individuals taking stable doses of other cholinesterase inhibitors can be included, but no study subject may initiate use of any cholinesterase inhibitor after entrance to trial.
•Individuals of both sexes over 50 years of age will be eligible

Exclusion criteria

•Significant neurological or psychiatric disease other than Alzheimer's disease.
•Patients with known or suspected Parkinsons's disease or dementia with Lewy bodies.
•Significant systemic illness (including uncontrolled hypertension) or organ failure.
•History of mental illness within one year or history of significant untreated cardiac or thromboembolic vascular disease (arrythmias, unstable angina, CVA, deep venous thrombosis, or pulmonary embolus).
•Current chronic use of anti-cholinergic medications (anti-histamines, and Artane or Cogentin). Stable doses of anxiolytics, sedatives, hypnotics, antipsychotics and SSRI antidepressants are acceptable. The use of any antipsychotics or tricyclic anti-depressants must be reviewed prior to entry.
•Diagnosis of major depression according to DSM-IV criteria in the last two years.
•Allergies to atorvastatin or HMG CoA reductase inhibitors.
•Pregnant women.
•History of head injury.
•On a cholesterol lowering drug at time of enrollment.
•History of significant liver disease and or elevated transaminases.
•Cholesterol level lower than 90 mg% at initial 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.

Publications (6)

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.