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

Monash University

Status and phase: Active, not recruiting; Phase 4

Conditions: Neuro-Degenerative Disease; Aging; Dementia of Alzheimer Type; Cognitive Decline; Dementia, Vascular; Dementia, Mixed; White Matter Hyperintensity

Treatments: Drug: Placebo; Drug: Atorvastatin 40 Mg Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT05586750

2006611

Details and patient eligibility

About

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.

Full 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.

Enrollment: 341 patients

Sex: All

Ages: 70+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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341 participants in 2 patient groups, including a placebo group

STAREE Statin group

Experimental group

Treatment:

Drug: Atorvastatin 40 Mg Oral Tablet

STAREE Placebo group

Placebo Comparator group

Treatment:

Drug: Placebo