Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Health and Medical Research Council, Australia | OTHER |
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | Metformin |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin XR, 500-2000mg nocte | Drug | Metformin XR, 500-2000mg nocte |
|
| Measure | Description | Time Frame |
|---|---|---|
| changes in memory Z-score | 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. | 3 years |
| changes in executive function Z-score | 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. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| changes in processing speed domain Z-score | processing speed domain measured by the i. WAIS-IV Coding; and ii. Trail Making Test part B | 3 years |
| changes in language performance domain Z-score |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Garvan Institute of Medical Research | Sydney | New South Wales | 2010 | Australia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D003704 | Dementia |
| D002561 | Cerebrovascular Disorders |
| D007333 | Insulin Resistance |
| D009410 | Nerve Degeneration |
| D007249 | Inflammation |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
Not provided
Not provided
randomised placebo controlled trial
Not provided
Not provided
Not provided
language performance domain measured by the Category Fluency (Animals) neuropsychological test
| 3 years |
| changes in attention performance domain Z-score | attention performance domain Z-score, measured by the WAIS-IV Digit Span Forward neuropsychological test | 3 years |
| changes in Cogstate brief battery performance Z-score | computerised cognition testing using the on-line test, the Cogstate brief battery (CBB) | 3 years |
| changes in total brain volume (cubic millimetres) | total grey and white matter volume | 3 years |
| changes in hippocampal volume (cubic millimetres) | volume of the right and left hippocampal regions of the brain | 3 years |
| changes in parahippocampal volume (cubic millimetres) | volume of the right and left parahippocampal regions of the brain | 3 years |
| changes in brain white matter hyperintensity number | the number of white matter hyperintensities visualised in bain imaging by magnetic resonance imaging | 3 years |
| changes in cerebral blood flow (mL / 100 g / min) | Cerebral blood flow will be measured using arterial spin labelling | 3 years |
| changes in cerebral amyloid tracer standardized uptake value ratio (SUVR) | standardized uptake value ratio of amyloid tracer using positron emission tomography | 3 years |
| changes in cognitive performance Z-score using the NIH tool box | The NIH Toolbox currently contains the following cognitive tests: Flanker, Pattern Comparison, Picture Sequence Memory and Dimensional Change Card Sort. | 3 years |
| change in BOLD (blood-oxygen-level-dependent) time-series signals measured by functional magnetic resonance imaging | change blood oxygen-level-dependent time-series signals, measured by functional MRI | 3 years |
| changes in biomarkers, including fasting glucose (mmol/L) and insulin (mIU/L), insulin resistance (HOMA-IR index) | fasting glucose (mmol/L) and insulin (mIU/L), insulin resistance (HOMA-IR index) | 3 years |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004700 | Endocrine System Diseases |