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PIT-ROAD

TerminatedPhase NAResults posted

The Clinical Study of Pitavastatin Treatment for Group of Mild to Moderate Alzheimer's Disease

Lead sponsor

Osaka University

Asset

Pitavastatin

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE ≤23

Primary endpoint

•Alzheimer's Disease Assessment Scale-cognitive Component-Japanese

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

NCT IDNCT00548145

Org study IDOSK-07098

Timeline

Milestones

Study first posted2007-10-23estimated

Study start2007-11 (month precision)

Primary completion2011-10actual (month precision)

Study completion2012-03actual (month precision)

Last update posted2012-06-14estimated

Results first posted2012-06-14estimated

Assets

Drug assets

Pitavastatin

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age20 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Alzheimer's Disease patients (15 ≤ MMSE total score ≤ 23, CDR "1" or "2")

•Patients with hypercholesterolemia

•Patients who have taken donepezil more than 3 months stably

•Both patients and care-givers must be more than 20 years old

Exclusion criteria

•Women with pregnancy or breast-feeding

•Malignant tumor

•Cerebrovascular disorder or myocardial infarction prior to 12 weeks

•Heart failure [New York Heart Association (NYHA) class III or IV]

•Hepatic or renal dysfunction

•Severe hypertension

•Hypothyroidism, hereditary muscular disease, history of drug-induced myopathy

•Current involvement in another investigational drug study

•Alcoholism, drug abuse

Endpoints (4)

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

Memory

Global cognition

2 endpoints

Secondary/protocol endpoint

MMSE, Neuropsychiatric Inventory, GDS-15, Zarit Burden Scale, Physical Self-Maintenance Scale, IADL, Everyday Memory Checklist, TC, HDL-C, Non HDL-C*, Apo A1, Apo B, Apo E *: Non HDL-C = (TC) - (HDL-C)

Time frame:baseline and 12 months

Mini-Mental State Examination (MMSE)

descriptive

Secondary/registry result

Time frame:baseline and 12 months

Mini-Mental State Examination (MMSE)

descriptive

Memory

2 endpoints

Primary/protocol endpoint

Alzheimer's Disease Assessment Scale-cognitive Component-Japanese Version(ADAS-Jcog)

Time frame:baseline and 12 months

descriptive

Primary/registry result

Alzheimer's Disease Assessment Scale-cognitive Component-Japanese Version(ADAS-Jcog)

Time frame:baseline and 12 months

descriptive

Posted result

Group	Value (mean), scores on a scale	Standard deviation
Pitavastatinbaselinen=17 Participants	18.59	6.13
12monthn=17 Participants	20.20	9.31
Cholesterol-lowering Medicine Other Than Statinbaselinen=16 Participants	19.50	5.61
12monthn=16 Participants	20.59	7.91

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.