Clinical trial

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

Name

2006611

Description

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.

Trial arms

Trial start

2019-09-19

Estimated PCD

2026-09-01

Trial end

2026-09-01

Status

Active (not recruiting)

Phase

Early phase I

Treatment

Atorvastatin 40 Mg Oral Tablet

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

Arms:

STAREE Statin group

Placebo

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

Arms:

STAREE Placebo group

Size

341

Primary endpoint

Free water

Change from baseline to four years

White matter hyperintensity volume

Change from baseline to four years

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 341, 'type': 'ACTUAL'}}

Updated at

2023-07-27

1 organization

1 product

1 drug

8 indications

Organization

Monash University

Product

Atorvastatin

Indication

Dementia