Preventing Cognitive Decline with Metformin:: the MetMemory Study
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- changes in memory Z-score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •overweight or obese (body mass index >25.0 kg/m2, waist: women>80 cm, men>94cm;
- •Mild cognitive impairment (Mild Neurocognitive Disorder), based on DSM-5 criteria;
- •Fasting blood glucose <7.0 mmol/L and HbA1c <6.5%;
- •Able to undertake neurocognitive testing in English.
- •Not participating in another trial of drugs or lifestyle modification to reduce cognitive decline.
排除标准
- •Life-threatening illnesses to preclude participation in a 3-year study;
- •Contraindications to the use of metformin (severe heart failure or eGFR <40).
研究组 & 干预措施
Intervention
Metformin
干预措施: Metformin XR, 500-2000mg nocte (Drug)
Placebo
Placebo
干预措施: Metformin XR, 500-2000mg nocte (Drug)
结局指标
主要结局
changes in memory Z-score
时间窗: 3 years
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.
changes in executive function Z-score
时间窗: 3 years
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.
次要结局
- changes in processing speed domain Z-score(3 years)
- changes in language performance domain Z-score(3 years)
- changes in attention performance domain Z-score(3 years)
- changes in Cogstate brief battery performance Z-score(3 years)
- changes in total brain volume (cubic millimetres)(3 years)
- changes in hippocampal volume (cubic millimetres)(3 years)
- changes in parahippocampal volume (cubic millimetres)(3 years)
- changes in brain white matter hyperintensity number(3 years)
- changes in cerebral blood flow (mL / 100 g / min)(3 years)
- changes in cerebral amyloid tracer standardized uptake value ratio (SUVR)(3 years)
- changes in cognitive performance Z-score using the NIH tool box(3 years)
- change in BOLD (blood-oxygen-level-dependent) time-series signals measured by functional magnetic resonance imaging(3 years)
- changes in biomarkers, including fasting glucose (mmol/L) and insulin (mIU/L), insulin resistance (HOMA-IR index)(3 years)