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

Sponsor

Monash University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05586750

Collaborator

National Health and Medical Research Council, Australia (Other)

330

Enrollment

Locations

Arms

83.4

Anticipated Duration (Months)

82.5

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dementia, Mixed Dementia, Vascular Dementia of Alzheimer Type Cognitive Decline White Matter Hyperintensity Aging Neuro-Degenerative Disease	Drug: Atorvastatin 40 Mg Oral Tablet Drug: Placebo	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

330 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 19, 2019

Anticipated Primary Completion Date :

Sep 1, 2026

Anticipated Study Completion Date :

Sep 1, 2026

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Free water [Change from baseline to four years]
Multi-compartment free water quantitation from brain diffusion-weighted MRI
Peri-vascular space volume [Change from baseline to four years]
From brain T1-weighted MRI
White matter hyperintensity volume [Change from baseline to four years]
From brain FLAIR MRI

Other Outcome Measures

Cortical thickness [Change from baseline to four years]
Cortical thickness as measured by T1-weighted structural MRI.
Hippocampal volume [Change from baseline to four years]
Microbleeds and lacunae [Change from baseline to four years]
Prefrontal cortex cerebral perfusion [Change from baseline to four years]
Prefrontal cortex cerebral perfusion as measured by pseudo-continuous arterial spin labelling (pCASL) MRI.
Whole-brain white matter fractional anisotropy [Change from baseline to four years]
Whole-brain white matter fractional anisotropy as measured by diffusion-weighted imaging (DWI) MRI.

Eligibility Criteria

Criteria

Ages Eligible for Study:

70 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Herston Imaging Research Facility (HIRF)	Herston	Queensland	Australia	4029
2	Herston Imaging Research Facility (HIRF)	Herston	Queensland	Australia	4029
3	Monash Biomedical Imaging (MBI)	Clayton	Victoria	Australia	3168
4	Monash Biomedical Imaging (MBI)	Clayton	Victoria	Australia	3168