Dementia, MixedPhase 4STAREE-MindNCT05586750
Statins in Reducing Events in the Elderly Mind (STAREE-Mind) Imaging Substudy
A Phase 4 study testing Atorvastatin 40 Mg Oral Tablet in people with Dementia, Mixed and Dementia, Vascular, run by Monash University at 2 sites in Australia.
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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Mixed, Dementia, Vascular, Dementia of Alzheimer Type
- What is being tested?
- Atorvastatin 40 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 341 participants
- Where
- 2 sitesAustralia
- Study dates
- 19 Sep 2019to Sep 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- Contraindications to have magnetic resonance neuroimaging performed.
- History of invasive brain surgery or known structural bran abnormalities.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Monash Biomedical Imaging (MBI)
Clayton, Victoria, 3168
Herston Imaging Research Facility (HIRF)
Herston, Queensland, 4029
About this study
Official title: Clinical Trial to Determine the Effects of Statins on Brain Health - STAREE-Mind Imaging Substudy
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.
Read the 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.
- Conditions
- Dementia, Mixed, Dementia, Vascular, Dementia of Alzheimer Type, Cognitive Decline, White Matter Hyperintensity, Aging
- Being tested
- Atorvastatin 40 Mg Oral Tablet, Placebo
- Keywords
- White matter mean diffusivity, Perivascular space, Free water, White matter hyperintensity
- Medical subject headings
- Mixed Dementias, Dementia, Vascular, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin 40 Mg Oral TabletDrug
40 mg atorvastatin (2 x 20 mg atorvastatin daily), taken orally
PlaceboDrug
2 x 20mg placebo (daily), taken orally. Identical appearance to study drug
| Study group | Role | What they receive |
|---|---|---|
| STAREE Statin group | Experimental | Not described Receives: Drug: Atorvastatin 40 Mg Oral Tablet |
| STAREE Placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Free water
Multi-compartment free water quantitation from brain diffusion-weighted MRI
Measured: Change from baseline to four years
White matter hyperintensity volume
From brain FLAIR MRI
Measured: Change from baseline to four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start19 Sep 2019
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dementia, MixedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 341 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Responsible party
- Principal investigator, Joanne Ryan, Monash University
- Investigators
- Sophia Zoungas, MBBS, FRACP, Principal investigator, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586750
- Sponsor's protocol ID
- 2006611
- Acronym
- STAREE-Mind
- Status last verified
- Nov 2024
- First submitted
- 10 Oct 2022
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After publication of the trial outcomes, the de-identified data will be available to approved researchers through a secure portal.
Publications
Harding IH, Ryan J, Heritier S, Spark S, Flanagan Z, McIntyre R, Anderson CS, Naismith SL, Chong TT, O'Sullivan M, Egan G, Law M, Zoungas S. STAREE-Mind Imaging Study: a randomised placebo-controlled trial of atorvastatin for prevention of cerebrovascular decline and neurodegeneration in older individuals. BMJ Neurol Open. 2023 Oct 31;5(2):e000541. doi: 10.1136/bmjno-2023-000541. eCollection 2023.
PubMed 37920607
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Determine the Effects of Statins on Brain Health - STAREE-Mind Imaging Substudy
- ClinicalTrials.gov ID
- NCT05586750
- Acronym / sponsor ID
- STAREE-Mind / 2006611
- Conditions
- Dementia, Mixed, Dementia, Vascular, Dementia of Alzheimer Type, Cognitive Decline, White Matter Hyperintensity, Aging
- Keywords
- White matter mean diffusivity, Perivascular space, Free water, White matter hyperintensity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 341 participants (actual)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Study start
- 19 Sep 2019 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 19 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STAREE Statin group | Experimental | Drug: Atorvastatin 40 Mg Oral Tablet |
| STAREE Placebo group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Contraindications to have magnetic resonance neuroimaging performed.
- History of invasive brain surgery or known structural bran abnormalities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin 40 Mg Oral Tablet40 mg atorvastatin (2 x 20 mg atorvastatin daily), taken orally | Drug | STAREE Statin group |
| Placebo2 x 20mg placebo (daily), taken orally. Identical appearance to study drug | Drug | STAREE Placebo group |
Primary outcome
Free water
Time frame: Change from baseline to four years
Multi-compartment free water quantitation from brain diffusion-weighted MRI
White matter hyperintensity volume
Time frame: Change from baseline to four years
From brain FLAIR MRI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Derived from this study: PubMed 37920607Harding IH, Ryan J, Heritier S, Spark S, Flanagan Z, McIntyre R, Anderson CS, Naismith SL, Chong TT, O'Sullivan M, Egan G, Law M, Zoungas S. STAREE-Mind Imaging Study: a randomised placebo-controlled trial of atorvastatin for prevention of cerebrovascular decline and neurodegeneration in older individuals. BMJ Neurol Open. 2023 Oct 31;5(2):e000541. doi: 10.1136/bmjno-2023-000541. eCollection 2023.
- Individual participant dataSharing planned: Yes. After publication of the trial outcomes, the de-identified data will be available to approved researchers through a secure portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophia Zoungas, MBBS, FRACP principal investigator
Monash University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atorvastatin 40 Mg Oral Tablet in people with Dementia, Mixed and Dementia, Vascular, run by Monash University at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Free water (time frame: Change from baseline to four years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05586750, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.