Clinical trial NCT05586750: Statins in Reducing Events in the Elderly Mind (STAREE-Mind) Imaging Substudy
Official title: Clinical Trial to Determine the Effects of Statins on Brain Health - STAREE-Mind Imaging Substudy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Dementia, Mixed
Dementia, Vascular
Dementia of Alzheimer Type
Cognitive Decline
White Matter Hyperintensity
Aging
Neuro-Degenerative Disease
Keywords: White matter mean diffusivity
Perivascular space
Free water
White matter hyperintensity
Lead sponsor: Monash University
Sponsor class: OTHER
Collaborators: name: National Health and Medical Research Council, Australia
First posted: 2022-10-19
Enrollment: 341
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Free water
timeFrame: Change from baseline to four years
measure: White matter hyperintensity volume
timeFrame: Change from baseline to four years
Secondary outcomes:
Other outcomes:
measure: Cortical thickness
timeFrame: Change from baseline to four years
measure: Hippocampal volume
timeFrame: Change from baseline to four years
measure: Microbleeds and lacunae
timeFrame: Change from baseline to four years
measure: Prefrontal cortex cerebral perfusion
timeFrame: Change from baseline to four years
measure: Whole-brain white matter fractional anisotropy
timeFrame: Change from baseline to four years
measure: Peri-vascular space volume
timeFrame: Change from baseline to four years
Locations:
city: Herston
country: Australia
facility: Herston Imaging Research Facility (HIRF)
state: Queensland
city: Clayton
country: Australia
facility: Monash Biomedical Imaging (MBI)
state: Victoria
Study officials:
affiliation: Monash University
name: Sophia Zoungas, MBBS, FRACP
role: PRINCIPAL_INVESTIGATOR
References: