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

Phase 4

Active, not recruiting

• Conditions: Dementia, Mixed; Dementia, Vascular; Dementia of Alzheimer Type; Cognitive Decline; White Matter Hyperintensity; Neuro-Degenerative Disease; Aging
• Interventions: Drug: Atorvastatin 40 Mg Oral Tablet; Drug: Placebo

• Registration Number: NCT05586750
• Lead Sponsor: Monash University

Brief Summary

The STAREE-Mind imaging sub-study will examine the effect of statin treatment over a 4-year period, compared with placebo, on markers of brain health.

Detailed Description

STAREE-Mind imaging is a sub-study nested in the Statins in Reducing Events in the Elderly (STAREE) double blind randomised placebo-controlled trial. STAREE is investigating whether statins can prolong good health and maintain independence amongst older people and is enrolling. STAREE-Mind imaging aims to recruit a sub-group of 340 participants, and will involve an additional suite of brain imaging in these participants, at recruitment (before medication is commenced) and at 4 years follow-up. It will provide crucial information about the clinical effects of statins on brain health in older individuals.

Study Timeline

• Study Start: 2019-09-19
• Study First Submitted: 2022-10-10
• Study First Submitted QC: 2022-10-15
• Study First Posted: 2022-10-19
• Status Verified: 2024-11
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 341

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STAREE Statin group	Atorvastatin 40 Mg Oral Tablet	-
STAREE Placebo group	Placebo	-

Primary Outcome Measures

Name	Time	Method
Free water	Change from baseline to four years	Multi-compartment free water quantitation from brain diffusion-weighted MRI
White matter hyperintensity volume	Change from baseline to four years	From brain FLAIR MRI

Trial Locations

Locations (2)

Monash Biomedical Imaging (MBI); 🇦🇺 Clayton, Victoria, Australia

Herston Imaging Research Facility (HIRF); 🇦🇺 Herston, Queensland, Australia