Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2026-01-05 @ 6:23 PM
Study NCT ID:
NCT05586750
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-22
First Post:
2022-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Statins in Reducing Events in the Elderly Mind (STAREE-Mind) Imaging Substudy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000093902', 'term': 'Mixed Dementias'}, {'id': 'D015140', 'term': 'Dementia, Vascular'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D002537', 'term': 'Intracranial Arteriosclerosis'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D056784', 'term': 'Leukoencephalopathies'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003072', 'term': 'Cognition Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 341}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2022-10-10', 'studyFirstSubmitQcDate': '2022-10-15', 'lastUpdatePostDateStruct': {'date': '2025-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cortical thickness', 'timeFrame': 'Change from baseline to four years', 'description': 'Cortical thickness as measured by T1-weighted structural MRI.'}, {'measure': 'Hippocampal volume', 'timeFrame': 'Change from baseline to four years'}, {'measure': 'Microbleeds and lacunae', 'timeFrame': 'Change from baseline to four years'}, {'measure': 'Prefrontal cortex cerebral perfusion', 'timeFrame': 'Change from baseline to four years', 'description': 'Prefrontal cortex cerebral perfusion as measured by pseudo-continuous arterial spin labelling (pCASL) MRI.'}, {'measure': 'Whole-brain white matter fractional anisotropy', 'timeFrame': 'Change from baseline to four years', 'description': 'Whole-brain white matter fractional anisotropy as measured by diffusion-weighted imaging (DWI) MRI.'}, {'measure': 'Peri-vascular space volume', 'timeFrame': 'Change from baseline to four years', 'description': 'From brain T1-weighted MRI'}], 'primaryOutcomes': [{'measure': 'Free water', 'timeFrame': 'Change from baseline to four years', 'description': 'Multi-compartment free water quantitation from brain diffusion-weighted MRI'}, {'measure': 'White matter hyperintensity volume', 'timeFrame': 'Change from baseline to four years', 'description': 'From brain FLAIR MRI'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['White matter mean diffusivity', 'Perivascular space', 'Free water', 'White matter hyperintensity'], 'conditions': ['Dementia, Mixed', 'Dementia, Vascular', 'Dementia of Alzheimer Type', 'Cognitive Decline', 'White Matter Hyperintensity', 'Aging', 'Neuro-Degenerative Disease']}, 'referencesModule': {'references': [{'pmid': '37920607', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '70 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants in the STAREE RCT and eligible for randomisation to study medication.\n* Men and women\n* Aged ≥70 years\n* Living independently in the community\n* Willing and able to provide informed consent and agree to participate in brain neuroimaging.\n* Able to attend one of the 2 sites (in Melbourne and Brisbane) where the imaging will take place.\n\nExclusion Criteria:\n\n* Contraindications to have magnetic resonance neuroimaging performed.\n* History of invasive brain surgery or known structural bran abnormalities.'}, 'identificationModule': {'nctId': 'NCT05586750', 'acronym': 'STAREE-Mind', 'briefTitle': 'Statins in Reducing Events in the Elderly Mind (STAREE-Mind) Imaging Substudy', 'organization': {'class': 'OTHER', 'fullName': 'Monash University'}, 'officialTitle': 'Clinical Trial to Determine the Effects of Statins on Brain Health - STAREE-Mind Imaging Substudy', 'orgStudyIdInfo': {'id': '2006611'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'STAREE Statin group', 'interventionNames': ['Drug: Atorvastatin 40 Mg Oral Tablet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'STAREE Placebo group', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Atorvastatin 40 Mg Oral Tablet', 'type': 'DRUG', 'description': '40 mg atorvastatin (2 x 20 mg atorvastatin daily), taken orally', 'armGroupLabels': ['STAREE Statin group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '2 x 20mg placebo (daily), taken orally. Identical appearance to study drug', 'armGroupLabels': ['STAREE Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4029', 'city': 'Herston', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Herston Imaging Research Facility (HIRF)', 'geoPoint': {'lat': -27.44453, 'lon': 153.01852}}, {'zip': '3168', 'city': 'Clayton', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Monash Biomedical Imaging (MBI)', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}], 'overallOfficials': [{'name': 'Sophia Zoungas, MBBS, FRACP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Monash University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'ipdSharing': 'YES', 'description': 'After publication of the trial outcomes, the de-identified data will be available to approved researchers through a secure portal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Monash University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Health and Medical Research Council, Australia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Joanne Ryan', 'investigatorAffiliation': 'Monash University'}}}}