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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

341 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-19

Study Completion Date

2026-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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STAREE Statin group

Group Type EXPERIMENTAL

Atorvastatin 40 Mg Oral Tablet

Intervention Type DRUG

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

STAREE Placebo group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Atorvastatin 40 Mg Oral Tablet

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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.