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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05586750
Registration number
NCT05586750
Ethics application status
Date submitted
10/10/2022
Date registered
19/10/2022
Date last updated
27/07/2023
Titles & IDs
Public title
Statins in Reducing Events in the Elderly Mind (STAREE-Mind) Imaging Substudy
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Scientific title
Clinical Trial to Determine the Effects of Statins on Brain Health - STAREE-Mind Imaging Substudy
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Secondary ID [1]
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2006611
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Universal Trial Number (UTN)
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Trial acronym
STAREE-Mind
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Dementia, Mixed
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Dementia, Vascular
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Dementia of Alzheimer Type
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Cognitive Decline
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White Matter Hyperintensity
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Aging
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Neuro-Degenerative Disease
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Condition category
Condition code
Neurological
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0
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Dementias
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Neurological
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0
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Alzheimer's disease
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Cardiovascular
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Neurological
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0
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Neurodegenerative diseases
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Mental Health
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0
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Atorvastatin 40 Mg Oral Tablet
Treatment: Drugs - Placebo
Experimental: STAREE Statin group -
Placebo Comparator: STAREE Placebo group -
Treatment: Drugs: Atorvastatin 40 Mg Oral Tablet
40 mg atorvastatin (2 x 20 mg atorvastatin daily), taken orally
Treatment: Drugs: Placebo
2 x 20mg placebo (daily), taken orally. Identical appearance to study drug
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Free water
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Assessment method [1]
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Multi-compartment free water quantitation from brain diffusion-weighted MRI
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Timepoint [1]
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Change from baseline to four years
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Primary outcome [2]
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White matter hyperintensity volume
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Assessment method [2]
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From brain FLAIR MRI
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Timepoint [2]
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Change from baseline to four years
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Eligibility
Key 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.
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Minimum age
70
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Contraindications to have magnetic resonance neuroimaging performed.
- History of invasive brain surgery or known structural bran abnormalities.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/09/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/09/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
341
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Herston Imaging Research Facility (HIRF) - Herston
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Recruitment hospital [2]
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Monash Biomedical Imaging (MBI) - Clayton
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Recruitment postcode(s) [1]
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4029 - Herston
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Recruitment postcode(s) [2]
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3168 - Clayton
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Funding & Sponsors
Primary sponsor type
Other
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Name
Monash University
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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National Health and Medical Research Council, Australia
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05586750
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Sophia Zoungas, MBBS, FRACP
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Address
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Monash University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05586750
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