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STAREE-Mind

Active not recruitingPhase 4

Statins in Reducing Events in the Elderly Mind (STAREE-Mind) Imaging Substudy

Clinical Trial to Determine the Effects of Statins on Brain Health - STAREE-Mind Imaging Substudy

Lead sponsor

Monash University

Asset

Atorvastatin

Listed sites

2

Recruiting sites

-

Enrollment

341

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age ≥70

Primary endpoints

•Free water•White matter hyperintensity volume

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 ID2006611
NCT IDNCT05586750

Timeline

Milestones

Study start2019-09-19actual
Study first posted2022-10-19actual
Last update posted2025-05-22actual
Primary completion2026-09estimated (month precision)
Study completion2026-09estimated (month precision)

Assets

Drug assets

Atorvastatin

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age70 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Participants in the STAREE RCT and eligible for randomisation to study medication.
•Men and women
•Aged ≥70 years
•Living independently in the community
•Willing and able to provide informed consent and agree to participate in brain neuroimaging.
•Able to attend one of the 2 sites (in Melbourne and Brisbane) where the imaging will take place

Exclusion criteria

•Contraindications to have magnetic resonance neuroimaging performed.
•History of invasive brain surgery or known structural bran abnormalities.

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

Neuroimaging
7
Other (unclassified)
1

Neuroimaging

7 endpoints
Primary/protocol endpoint

Free water

Time frame:Change from baseline to four years

descriptive

Primary/protocol endpoint

White matter hyperintensity volume

Time frame:Change from baseline to four years

descriptive

Other/protocol endpoint

Cortical thickness

Time frame:Change from baseline to four years

descriptive

Other/protocol endpoint

Hippocampal volume

Time frame:Change from baseline to four years

descriptive

Other/protocol endpoint

Prefrontal cortex cerebral perfusion

Time frame:Change from baseline to four years

descriptive

Other/protocol endpoint

Whole-brain white matter fractional anisotropy

Time frame:Change from baseline to four years

descriptive

Other/protocol endpoint

Peri-vascular space volume

Time frame:Change from baseline to four years

descriptive

Other (unclassified)

1 endpoint
Other/protocol endpoint/low confidence

Microbleeds and lacunae

Time frame:Change from baseline to four years

descriptive

Publications (1)

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.