← Trials/Trial dossier/NCT00486044

ESPRIT

CompletedPhase 2Results posted

Evaluating Simvastatin's Potential Role in Therapy

Effect of Statins on Pathobiology of Alzheimer's Disease

Lead sponsor

University of Wisconsin, Madison

Asset

Simvastatin

Listed sites

Recruiting sites

Enrollment

103

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Age 35-69•MRI contraindications excluded

Primary endpoint

•Cerebrospinal Fluid (CSF) Beta-amyloid-42

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

Nih1K23AG026752-01

Org study IDIA0116

NCT IDNCT00486044

Timeline

Milestones

Study start2005-02 (month precision)

Study first posted2007-06-13estimated

Primary completion2009-06actual (month precision)

Study completion2009-06actual (month precision)

Results first posted2015-11-05estimated

Last update posted2019-03-05actual

Assets

Drug assets

Simvastatin

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age35 Years

Maximum age69 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Age 35 to 69

•Parent with Alzheimer's disease

Exclusion criteria

•Current use of cholesterol-lowering medication

•Active liver disease

•History of adverse reaction to statins

•Contraindication to lumbar puncture

•Elevated lab values (creatine kinase and creatinine)

•Use of medications known to interact with statins

•History of dementia

•Currently pregnant or planning to become pregnant

•Use of large quantities of grapefruit juice (more than 1 quart per day)

•Current involvement in another investigational drug study

•Contraindications to MRI (for MRI sub-study)

•Ethical contraindication to placebo (persons with high vascular risk)

Endpoints (8)

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

Global cognition

Amyloid biomarkers

Neuroimaging

Other (unclassified)

Global cognition

2 endpoints

Secondary/protocol endpoint

Changes in Cognitive Performance

Time frame:Baseline and 9 months

change from baseline, improvement

Secondary/registry result

Changes in Cognitive Performance

Time frame:Baseline and 9 months

change from baseline, improvement

Posted result

Group	Value (mean), adjusted words recalled	Standard deviation
Simvastatinn=48 Participants	0.40	1.38
Placebon=46 Participants	0.26	1.54

p0.210Kruskal-Wallis

Amyloid biomarkers

2 endpoints

Primary/protocol endpoint

Change in Cerebrospinal Fluid (CSF) Beta-amyloid-42

Time frame:baseline and 9 months

change from baseline, improvement

Primary/registry result

Change in Cerebrospinal Fluid (CSF) Beta-amyloid-42

Time frame:baseline and 9 months

change from baseline, improvement

Posted result

Group	Value (mean), ng/L	Standard deviation
Simvastatinn=48 Participants	-5.2	44.1
Placebon=45 Participants	-3.1	38.2

p0.966Kruskal-Wallis

Neuroimaging

2 endpoints

Secondary/protocol endpoint

Changes in Regional Cerebral Blood Flow on MRI

Time frame:baseline and 9 months

descriptive

Secondary/registry result

Changes in Regional Cerebral Blood Flow on MRI

Time frame:baseline and 9 months

descriptive

Posted result

Group	Value (mean), mL/100 g/min	Standard deviation
Simvastatinn=24 Participants	4.09	6.69
Placebon=17 Participants	-5.08	8.28

p0.015ANCOVA

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Change in Inflammatory Markers

Time frame:baseline and 9 months

change from baseline, improvement

Secondary/registry result/low confidence

Change in Inflammatory Markers

Time frame:baseline and 9 months

change from baseline, improvement

Posted result

Group	Value (mean), mg/L	Standard deviation
Simvastatinn=47 Participants	-1.16	3.55
Placebon=43 Participants	-0.31	1.83

p0.113Kruskal-Wallis

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 tableClinicalTrials.gov results section

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.