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SimBio

CompletedPhase 4Results posted

Effects of Simvastatin on Biomarkers

Effects of Simvastatin on CSF AD Biomarkers in Cognitively Normal Subjects

Lead sponsor

University of Washington

Asset

Simvastatin

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•MMSE ≥26

Primary endpoints

•Aβ42 in Cerebrospinal Fluid (CSF)•CSF Total Tau•Phosphorylated tau 181 (p-tau181)

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

Secondary ID00183VA Puget Sound Health System MIRB#

Org study ID37373

NCT IDNCT01142336

Timeline

Milestones

Study start2010-06 (month precision)

Study first posted2010-06-11estimated

Primary completion2015-10actual (month precision)

Study completion2015-10actual (month precision)

Last update posted2017-07-28actual

Results first posted2017-07-28actual

Assets

Drug assets

Simvastatin

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age45 Years

Maximum age64 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

(participants must meet the following criteria)

•If female of childbearing potential, must have negative pregnancy test at baseline, and all subsequent visits.

•Age 45 to 64 years inclusive.

•Considered cognitively normal with no evidence of memory or other cognitive impairments (MMSE >26, Logical Memory delayed recall > 6, CDR score of 0).

•Normal or only mildly elevated cholesterol which does not require drug therapy based on National Cholesterol Education Program Adult Treatment Panel III (NCEP/ATP-III) guidelines.

•An LDL level above 70mg/dL.

•Hamilton Depression Scale (HAM-D) score < 12.

•BMI between 18 - 34 (or exception made by MD).

•In good recent general health (i.e., no trauma or infection in the 4 weeks before LP).

•On stable dose of non-exclusionary medications for the 4 weeks preceding the LP.

•Platelet count >100,000

Exclusion criteria

(participants must NOT satisfy any of the following conditions)

•Any contraindications to LP, such as spinal deformity, severe disease or infection in the LP region, bleeding tendency, anticoagulant or blood-thinning medications.

•Taken a statin medication in the past 12 months.

•Any clinically significant laboratory abnormalities.

•Any neurological disorders: multiple sclerosis, epilepsy, stroke, Parkinson's, other degenerative CNS disorders, or neuropathy with radicular involvement.

•Acute or chronic major psychiatric disorders: schizophrenia, affective disorders, or severe anxiety disorders. (Dysthymia allowed, history of MDD allowed if currently in remission)

•Unstable or poorly controlled medical problems such as: heart failure, diabetes (poorly controlled or insulin dependent), hypertension (BP >160/100), pulmonary disease with hypoxia or hypercapnia, significant liver disease or known hepatitis C seropositivity, renal failure, treatment for cancer in the past 2 years (other than non-melanoma skin cancer) or known HIV positive status.

•Use of illegal drugs or alcohol abuse (>2 drinks/day or 10/week) within the past year.

•Concurrent participation in another investigational drug study.

•Use of any exclusionary medications in the 4 weeks prior to screening:

-Drugs which could interact with statins: itraconazole, ketoconazole, erythromycin, clarithromycin, HIV protease inhibitors, nefazodone, amiodarone, cyclosporine, isoniazid, quinidine, or large quantities of grapefruit juice (>1 quart daily)

-Central nervous system acting medications: antipsychotics, anti-Parkinson's disease medications, anti convulsants, or CNS stimulants

-Chronic use of benzodiazepines, sedating antihistamines, or other sedative-hypnotic agents (prn use is allowed as long as it is not within 72 hours of LP or cognitive testing)

-Medications affecting coagulation and/or inflammation: coumadin, potent anti-inflammatory medications (hydrocortisone, methotrexate or other potent immune-modulating medications), and anti-HIV medications (Aspirin up to 325 mg/day is allowed.)

-Lipid-lowering drugs: fibrates or niacin >500mg/day (stable dose of omega-3 is allowed)

•Does the subject's family history meet any of the following criteria?

-Both parents had/have dementia

-On one side of the family, over two consecutive generations three relatives had/have dementia?

-One parent had an onset of dementia before age 60?

•Does the subject have a major active autoimmune or immunological disorder?

Endpoints (6)

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

Tau biomarkers

Amyloid biomarkers

2 endpoints

Primary/protocol endpoint

Change From Baseline in Aβ42 in Cerebrospinal Fluid (CSF) at 1 Year

Time frame:1-year change of CSF Aβ42 from baseline

change from baseline, improvement

Primary/registry result

Change From Baseline in Aβ42 in Cerebrospinal Fluid (CSF) at 1 Year

Time frame:1-year change of CSF Aβ42 from baseline

change from baseline, improvement

Posted result

Group	Value (mean), 1-yr change, pg/ml	Standard deviation
Placebon=21 Participants	5.3	31
Simvastatinn=25 Participants	0.5	42

p0.53ANCOVA

Tau biomarkers

4 endpoints

Primary/protocol endpoint

Change From Baseline in CSF Total Tau at 1 Year

Time frame:1-yr change

change from baseline, improvement

Primary/protocol endpoint

Change From Baseline in CSF ptau181 at 1 Year

Time frame:1-year change from baseline

Phosphorylated tau 181 (p-tau181)

change from baseline, improvement

Primary/registry result

Change From Baseline in CSF Total Tau at 1 Year

Time frame:1-yr change

change from baseline, improvement

Posted result

Group	Value (mean), pg/ml	Standard deviation
Placebon=21 Participants	-0.1	3.9
Simvastatinn=25 Participants	1.6	4.7

p0.36ANCOVA

Primary/registry result

Change From Baseline in CSF ptau181 at 1 Year

Time frame:1-year change from baseline

Phosphorylated tau 181 (p-tau181)

change from baseline, improvement

Posted result

Group	Value (mean), 1-yr change (final - baseline), pg/ml	Standard deviation
Placebon=21 Participants	-2.9	12.9
Simvastatinn=25 Participants	1.7	6.3

p0.25ANCOVA

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.