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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05586750




Registration number
NCT05586750
Ethics application status
Date submitted
10/10/2022
Date registered
19/10/2022

Titles & IDs
Public title
Statins in Reducing Events in the Elderly Mind (STAREE-Mind) Imaging Substudy
Scientific title
Clinical Trial to Determine the Effects of Statins on Brain Health - STAREE-Mind Imaging Substudy
Secondary ID [1] 0 0
2006611
Universal Trial Number (UTN)
Trial acronym
STAREE-Mind
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dementia, Mixed 0 0
Dementia, Vascular 0 0
Dementia of Alzheimer Type 0 0
Cognitive Decline 0 0
White Matter Hyperintensity 0 0
Aging 0 0
Neuro-Degenerative Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Dementias
Neurological 0 0 0 0
Alzheimer's disease
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Neurological 0 0 0 0
Neurodegenerative diseases
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Free water
Timepoint [1] 0 0
Change from baseline to four years
Primary outcome [2] 0 0
White matter hyperintensity volume
Timepoint [2] 0 0
Change from baseline to four years

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.
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Contraindications to have magnetic resonance neuroimaging performed.
* History of invasive brain surgery or known structural bran abnormalities.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2026
Actual
Sample size
Target
Accrual to date
Final
341
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Herston Imaging Research Facility (HIRF) - Herston
Recruitment hospital [2] 0 0
Monash Biomedical Imaging (MBI) - Clayton
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment postcode(s) [2] 0 0
3168 - Clayton

Funding & Sponsors
Primary sponsor type
Other
Name
Monash University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National Health and Medical Research Council, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sophia Zoungas, MBBS, FRACP
Address 0 0
Monash University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After publication of the trial outcomes, the de-identified data will be available to approved researchers through a secure portal.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05586750