NCT05586750

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
341

participants targeted

Target at P75+ for phase_4

Timeline
4mo left

Started Sep 2019

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Sep 2019Sep 2026

Study Start

First participant enrolled

September 19, 2019

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 19, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

May 22, 2025

Status Verified

November 1, 2024

Enrollment Period

7 years

First QC Date

October 10, 2022

Last Update Submit

May 19, 2025

Conditions

Dementia, MixedDementia, VascularDementia of Alzheimer TypeCognitive DeclineWhite Matter HyperintensityAgingNeuro-Degenerative Disease

Keywords

White matter mean diffusivityPerivascular spaceFree waterWhite matter hyperintensity

Outcome Measures

Primary Outcomes (2)

  • Free water

    Multi-compartment free water quantitation from brain diffusion-weighted MRI

    Change from baseline to four years

  • White matter hyperintensity volume

    From brain FLAIR MRI

    Change from baseline to four years

Other Outcomes (6)

  • Cortical thickness

    Change from baseline to four years

  • Hippocampal volume

    Change from baseline to four years

  • Microbleeds and lacunae

    Change from baseline to four years

  • +3 more other outcomes

Study Arms (2)

STAREE Statin group

EXPERIMENTAL
Drug: Atorvastatin 40 Mg Oral Tablet

STAREE Placebo group

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Atorvastatin 40 Mg Oral TabletDRUG

40 mg atorvastatin (2 x 20 mg atorvastatin daily), taken orally

STAREE Statin group
PlaceboDRUG

2 x 20mg placebo (daily), taken orally. Identical appearance to study drug

STAREE Placebo group

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Herston Imaging Research Facility (HIRF)

Herston, Queensland, 4029, Australia

Location

Monash Biomedical Imaging (MBI)

Clayton, Victoria, 3168, Australia

Location

Related Publications (1)

  • Harding IH, Ryan J, Heritier S, Spark S, Flanagan Z, McIntyre R, Anderson CS, Naismith SL, Chong TT, O'Sullivan M, Egan G, Law M, Zoungas S. STAREE-Mind Imaging Study: a randomised placebo-controlled trial of atorvastatin for prevention of cerebrovascular decline and neurodegeneration in older individuals. BMJ Neurol Open. 2023 Oct 31;5(2):e000541. doi: 10.1136/bmjno-2023-000541. eCollection 2023.

    PMID: 37920607DERIVED

MeSH Terms

Conditions

Mixed DementiasDementia, VascularCognitive Dysfunction

Interventions

AtorvastatinTablets

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersCerebrovascular DisordersIntracranial ArteriosclerosisIntracranial Arterial DiseasesLeukoencephalopathiesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesCognition Disorders

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsDosage FormsPharmaceutical Preparations

Study Officials

  • Sophia Zoungas, MBBS, FRACP

    Monash University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 10, 2022

First Posted

October 19, 2022

Study Start

September 19, 2019

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

May 22, 2025

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will share

After publication of the trial outcomes, the de-identified data will be available to approved researchers through a secure portal.

Shared Documents
STUDY PROTOCOL, SAP

Locations

AU(2)