Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
Study NCT ID:
NCT04511416
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-10-02
First Post:
2020-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preventing Cognitive Decline with Metformin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D009410', 'term': 'Nerve Degeneration'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomised placebo controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 242}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-01', 'studyFirstSubmitDate': '2020-07-02', 'studyFirstSubmitQcDate': '2020-08-10', 'lastUpdatePostDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in memory Z-score', 'timeFrame': '3 years', 'description': 'memory domain Z-score, derived from the following neuropsychological tests: i. Rey Auditory Verbal Learning Test (RAVLT); ii. Total Learning and Delayed recall; iii. the Logical Memory Story A- Immediate Recall; and iv. Delayed Recall tests.'}, {'measure': 'changes in executive function Z-score', 'timeFrame': '3 years', 'description': 'executive function domain Z-score, derived from the following neuropsychological tests: i. Alphabet test; ii. D-KEFS Stroop; iii. Trail Making Test Part B; iv. Weschler Adult Intelligence Scale-IV (WAIS-IV) Digit Span Backward test.'}], 'secondaryOutcomes': [{'measure': 'changes in processing speed domain Z-score', 'timeFrame': '3 years', 'description': 'processing speed domain measured by the i. WAIS-IV Coding; and ii. Trail Making Test part B'}, {'measure': 'changes in language performance domain Z-score', 'timeFrame': '3 years', 'description': 'language performance domain measured by the Category Fluency (Animals) neuropsychological test'}, {'measure': 'changes in attention performance domain Z-score', 'timeFrame': '3 years', 'description': 'attention performance domain Z-score, measured by the WAIS-IV Digit Span Forward neuropsychological test'}, {'measure': 'changes in Cogstate brief battery performance Z-score', 'timeFrame': '3 years', 'description': 'computerised cognition testing using the on-line test, the Cogstate brief battery (CBB)'}, {'measure': 'changes in total brain volume (cubic millimetres)', 'timeFrame': '3 years', 'description': 'total grey and white matter volume'}, {'measure': 'changes in hippocampal volume (cubic millimetres)', 'timeFrame': '3 years', 'description': 'volume of the right and left hippocampal regions of the brain'}, {'measure': 'changes in parahippocampal volume (cubic millimetres)', 'timeFrame': '3 years', 'description': 'volume of the right and left parahippocampal regions of the brain'}, {'measure': 'changes in brain white matter hyperintensity number', 'timeFrame': '3 years', 'description': 'the number of white matter hyperintensities visualised in bain imaging by magnetic resonance imaging'}, {'measure': 'changes in cerebral blood flow (mL / 100 g / min)', 'timeFrame': '3 years', 'description': 'Cerebral blood flow will be measured using arterial spin labelling'}, {'measure': 'changes in cerebral amyloid tracer standardized uptake value ratio (SUVR)', 'timeFrame': '3 years', 'description': 'standardized uptake value ratio of amyloid tracer using positron emission tomography'}, {'measure': 'changes in cognitive performance Z-score using the NIH tool box', 'timeFrame': '3 years', 'description': 'The NIH Toolbox currently contains the following cognitive tests: Flanker, Pattern Comparison, Picture Sequence Memory and Dimensional Change Card Sort.'}, {'measure': 'change in BOLD (blood-oxygen-level-dependent) time-series signals measured by functional magnetic resonance imaging', 'timeFrame': '3 years', 'description': 'change blood oxygen-level-dependent time-series signals, measured by functional MRI'}, {'measure': 'changes in biomarkers, including fasting glucose (mmol/L) and insulin (mIU/L), insulin resistance (HOMA-IR index)', 'timeFrame': '3 years', 'description': 'fasting glucose (mmol/L) and insulin (mIU/L), insulin resistance (HOMA-IR index)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cognitive decline', 'dementia', 'cerebrovascular disease', 'insulin resistance', 'neurodegeneration', 'inflammation', 'diabetes'], 'conditions': ['Cognitive Decline']}, 'descriptionModule': {'briefSummary': 'A randomised control study of metformin in people with mild cognitive impairment and without diabetes mellitus to determine effects on cognitive decline and neuroimaging over 3 years.', 'detailedDescription': 'A randomised placebo-control study of metformin in people with mild cognitive impairment and without diabetes mellitus to determine effects on cognitive decline, neuroimaging and biomarkers over 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* overweight or obese (body mass index \\>25.0 kg/m2, waist: women\\>80 cm, men\\>94cm;\n* Mild cognitive impairment (Mild Neurocognitive Disorder), based on DSM-5 criteria;\n* Fasting blood glucose \\<7.0 mmol/L and HbA1c \\<6.5%;\n* Able to undertake neurocognitive testing in English.\n* Not participating in another trial of drugs or lifestyle modification to reduce cognitive decline.\n\nExclusion Criteria:\n\n* Life-threatening illnesses to preclude participation in a 3-year study;\n* Contraindications to the use of metformin (severe heart failure or eGFR \\<40).'}, 'identificationModule': {'nctId': 'NCT04511416', 'acronym': 'MetMemory', 'briefTitle': 'Preventing Cognitive Decline with Metformin', 'organization': {'class': 'OTHER', 'fullName': 'Garvan Institute of Medical Research'}, 'officialTitle': 'Preventing Cognitive Decline with Metformin:: the MetMemory Study', 'orgStudyIdInfo': {'id': '1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'Metformin', 'interventionNames': ['Drug: Metformin XR, 500-2000mg nocte']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Metformin XR, 500-2000mg nocte']}], 'interventions': [{'name': 'Metformin XR, 500-2000mg nocte', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Metformin XR, 500-2000mg nocte', 'armGroupLabels': ['Intervention', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2010', 'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Garvan Institute of Medical Research', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Garvan Institute of Medical Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Health and Medical Research Council, Australia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}