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Delfa

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CompletedPhase 4

Do HMG CoA Reductase Inhibitors Affect Abeta Levels?

Assets

pravastatin / Simvastatin

Listed sites

1

Recruiting sites

-

Enrollment

35

actual

Study population

Alzheimer’s disease

Key I/E criterion

Age 18-90

Primary endpoint

CSF abeta levels

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 ID21974
NCT IDNCT00303277

Timeline

Milestones

Study start2002-08 (month precision)
Primary completion2005-04actual (month precision)
Study completion2005-04actual (month precision)
Study first posted2006-03-16estimated
Last update posted2010-04-13estimated

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years
Maximum age90 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Total cholesterol > 200, and/or LDL > 130
No cognitive impairment
Statin-naive for at least one year
Women must not be pregnant, nursing, or planning to become pregnant

Exclusion criteria

Back ailments which would hinder LP procedure
Neurological disease, including stroke, Parkinson's disease, Multiple Sclerosis, uncontrolled epilepsy, history of severe head trauma
Hepatic disease
Renal insufficiency
Unstable medical disease
Severe pulmonary disease
Severe cardiac disease
Uncontrolled hypertension (greater than 160/90)
Uncontrolled hyper/hypothyroidism
History of blood clotting abnormalities or platelet abnormalities
History of chronic major psychiatric disorders or presence of current major depressive disorder (by DSM-IV criteria)
History of substance abuse within the past year
Taking exclusionary medications

Endpoints (2)

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.

Coverage by outcome category

Amyloid biomarkers
1
Fluid / digital biomarkers
1

Amyloid biomarkers

1 endpoint
Primary/protocol endpoint

CSF abeta levels

Time frame:baseline and 12 weeks

descriptive

Fluid / digital biomarkers

1 endpoint
Secondary/protocol endpoint

CSF biomarkers

Time frame:baseline and 12 weeks

descriptive

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.

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.