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

Aging Clinical Trial

— STAREE-Mind  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05586750
• Other study ID #: 2006611
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: September 19, 2019
• Est. completion date: September 2026

Study information

• Verified date: July 2023
• Source: Monash University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 341
• Est. completion date: September 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 70 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Atorvastatin 40 Mg Oral Tablet
40 mg atorvastatin (2 x 20 mg atorvastatin daily), taken orally
• Placebo
2 x 20mg placebo (daily), taken orally. Identical appearance to study drug

Locations

Country	Name	City	State
Australia	Monash Biomedical Imaging (MBI)	Clayton	Victoria
Australia	Herston Imaging Research Facility (HIRF)	Herston	Queensland

Sponsors (2)

Lead Sponsor	Collaborator
Monash University	National Health and Medical Research Council, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cortical thickness	Cortical thickness as measured by T1-weighted structural MRI.	Change from baseline to four years
Other	Hippocampal volume		Change from baseline to four years
Other	Microbleeds and lacunae		Change from baseline to four years
Other	Prefrontal cortex cerebral perfusion	Prefrontal cortex cerebral perfusion as measured by pseudo-continuous arterial spin labelling (pCASL) MRI.	Change from baseline to four years
Other	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
Other	Peri-vascular space volume	From brain T1-weighted MRI	Change from baseline to four years
Primary	Free water	Multi-compartment free water quantitation from brain diffusion-weighted MRI	Change from baseline to four years
Primary	White matter hyperintensity volume	From brain FLAIR MRI	Change from baseline to four years