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

Primary Purpose

Dementia, Mixed, Dementia, Vascular, Dementia of Alzheimer Type

Status

Active

Phase

Phase 4

Locations

Australia

Study Type

Interventional

Intervention

Atorvastatin 40 Mg Oral Tablet

Placebo

About this trial

This is an interventional prevention trial for Dementia, Mixed focused on measuring White matter mean diffusivity, Perivascular space, Free water, White matter hyperintensity

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesAccepts 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.

Sites / Locations

Herston Imaging Research Facility (HIRF)
Monash Biomedical Imaging (MBI)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

STAREE Statin group

STAREE Placebo group

Arm Description

Outcomes

Primary Outcome Measures

Free water

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

White matter hyperintensity volume

From brain FLAIR MRI

Secondary Outcome Measures

Full Information

NCT ID

NCT05586750

First Posted

October 10, 2022

Last Updated

July 24, 2023

Sponsor

Monash University

Collaborators

National Health and Medical Research Council, Australia

1. Study Identification

Unique Protocol Identification Number

NCT05586750

Brief Title

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

Acronym

STAREE-Mind

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 19, 2019 (Actual)

Primary Completion Date

September 2026 (Anticipated)

Study Completion Date

September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Monash University

Collaborators

National Health and Medical Research Council, Australia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

341 (Actual)

8. Arms, Groups, and Interventions

Arm Title

STAREE Statin group

Arm Type

Experimental

Arm Title

STAREE Placebo group

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Atorvastatin 40 Mg Oral Tablet

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Free water

Description

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

Time Frame

Change from baseline to four years

Title

White matter hyperintensity volume

Description

From brain FLAIR MRI

Time Frame

Change from baseline to four years

Other Pre-specified Outcome Measures:

Title

Cortical thickness

Description

Cortical thickness as measured by T1-weighted structural MRI.

Time Frame

Change from baseline to four years

Title

Hippocampal volume

Time Frame

Change from baseline to four years

Title

Microbleeds and lacunae

Time Frame

Change from baseline to four years

Title

Prefrontal cortex cerebral perfusion

Description

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

Time Frame

Change from baseline to four years

Title

Whole-brain white matter fractional anisotropy

Description

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

Time Frame

Change from baseline to four years

Title

Peri-vascular space volume

Description

From brain T1-weighted MRI

Time Frame

Change from baseline to four years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sophia Zoungas, MBBS, FRACP

Organizational Affiliation

Monash University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Herston Imaging Research Facility (HIRF)

City

Herston

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

Monash Biomedical Imaging (MBI)

City

Clayton

State/Province

Victoria

ZIP/Postal Code

3168

Country

Australia

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

After publication of the trial outcomes, the de-identified data will be available to approved researchers through a secure portal.

Learn more about this trial

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

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