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NCT Number: NCT05586750

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Dementia, Mixed Aging Arterial Occlusive Diseases Arteriosclerosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognition Disorders Cognitive Decline Cognitive Dysfunction Dementia Dementia of Alzheimer Type Dementia, Vascular Intracranial Arterial Diseases Intracranial Arteriosclerosis Leukoencephalopathies Mental Disorders Mixed Dementias Nervous System Diseases Neuro-Degenerative Disease Neurocognitive Disorders Vascular Diseases White Matter Hyperintensity

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Herston Imaging Research Facility (HIRF), Herston, Queensland, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Atorvastatin 40 Mg Oral Tablet

Drug

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

Placebo

Drug

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

Primary outcomes

  1. Free water

    Time frame: Change from baseline to four years

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

  2. White matter hyperintensity volume

    Time frame: Change from baseline to four years

    From brain FLAIR MRI

Other outcomes

  1. Cortical thickness

    Time frame: Change from baseline to four years

    Cortical thickness as measured by T1-weighted structural MRI.

  2. Hippocampal volume

    Time frame: Change from baseline to four years

  3. Microbleeds and lacunae

    Time frame: Change from baseline to four years

  4. Prefrontal cortex cerebral perfusion

    Time frame: Change from baseline to four years

    Prefrontal cortex cerebral perfusion as measured by pseudo-continuous arterial spin labelling (pCASL) MRI.

  5. Whole-brain white matter fractional anisotropy

    Time frame: Change from baseline to four years

    Whole-brain white matter fractional anisotropy as measured by diffusion-weighted imaging (DWI) MRI.

  6. Peri-vascular space volume

    Time frame: Change from baseline to four years

    From brain T1-weighted MRI

Sponsors and collaborators

Lead sponsor

Monash University

Other

Collaborators

  • National Health and Medical Research Council, Australia

Registry information

Official study title

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

Acronym: STAREE-Mind

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Oct 19, 2022
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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