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

Clinical Trial to Determine the Effects of Statins on Brain Health - 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aging; Dementia, Vascular; Cognitive Decline; Dementia, Mixed; Neuro-Degenerative Disease; Dementia of Alzheimer Type; White Matter Hyperintensity
• Intervention / Treatment: Drug: Atorvastatin 40 Mg Oral Tablet; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 341
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Joanne Ryan, PhD; Phone Number: +61 399030200; Email: joanne.ryan@monash.edu
• Study Contact Backup: Name: Ian Harding, PhD; Phone Number: +61 3 9905 9283; Email: ian.harding@monash.edu

Study Locations

• Australia
  • Queensland
    • Herston, Queensland, Australia, 4029
      • Herston Imaging Research Facility (HIRF)
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Biomedical Imaging (MBI)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 68 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STAREE Statin group	Drug: Atorvastatin 40 Mg Oral Tablet; 40 mg atorvastatin (2 x 20 mg atorvastatin daily), taken orally
Placebo Comparator: STAREE Placebo group	Drug: Placebo; 2 x 20mg placebo (daily), taken orally. Identical appearance to study drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peri-vascular space volume	From brain T1-weighted MRI	Change from baseline to four years
Cortical thickness	Cortical thickness as measured by T1-weighted structural MRI.	Change from baseline to four years
Hippocampal volume		Change from baseline to four years
Microbleeds and lacunae		Change from baseline to four years
Prefrontal cortex cerebral perfusion	Prefrontal cortex cerebral perfusion as measured by pseudo-continuous arterial spin labelling (pCASL) MRI.	Change from baseline to four years
Whole-brain white matter fractional anisotropy	Whole-brain white matter fractional anisotropy as measured by diffusion-weighted imaging (DWI) MRI.	Change from baseline to four years

Collaborators and Investigators

• Sponsor: Monash University
• Collaborators: National Health and Medical Research Council, Australia
• Investigators: Principal Investigator: Sophia Zoungas, MBBS, FRACP, Monash University

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2019
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: October 10, 2022
• First Submitted That Met QC Criteria: October 15, 2022
• First Posted (Actual): October 19, 2022

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: White matter mean diffusivity; Perivascular space; Free water; White matter hyperintensity
• Additional Relevant MeSH Terms: Mental Disorders; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Neurocognitive Disorders; Tauopathies; Cognition Disorders; Intracranial Arterial Diseases; Intracranial Arteriosclerosis; Leukoencephalopathies; Dementia; Alzheimer Disease; Cognitive Dysfunction; Neurodegenerative Diseases; Dementia, Vascular; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin
• Other Study ID Numbers: 2006611

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After publication of the trial outcomes, the de-identified data will be available to approved researchers through a secure portal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No