CTIS2022-500438-27-01招募中1 期
Multimodal METformin and FINGER lifestyle intervention to prevent cognitive impairment and disability in older adults at risk for dementia: a phase IIb multi-national randomised, controlled trial. - 21CX6667
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •For all: Age 60-79 years, For all: CAIDE Dementia Risk Score =6 points, For all: Cognitive performance at the mean level or slightly lower than expected for age according to local population norms based on the MoCA test and the CERAD verbal learning test., For all: Proficiency in the local language (English, Finnish or Swedish), For metformin/placebo group: No diagnosed diabetes or known contraindications to metformin treatment., For metformin/placebo group: Elevated adiposity (BMI=25 kg/m2 OR waist circumference > 102 cm in men and > 88 cm in women) OR mildly impaired fasting glucose (6.1-6.9 mmol/l).
排除标准
- •For all: Dementia or substantial cognitive impairment (e.g., memory clinic referral needed as judged by the study physician)., For metformin/placebo group: History of intolerance to metformin used for any indication., For metformin/placebo group: Diabetes diagnosed or suspected at baseline (e.g., HbA1c=6.5%, fasting glucose =7 mmol/l, or 2HPG=11.1 mmol/l)., For metformin/placebo group: Hypersensitivity to metformin or to any of the excipients or placebo compounds., For metformin/placebo group: Metformin contraindications, e.g., history/presence of known renal or liver disease, congestive heart failure, alcohol abuse, calculated GFR<60 ml/min., For metformin/placebo group: Any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis), For metformin/placebo group: Acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock., For metformin/placebo group: Disease which may cause tissue hypoxia (especially acute disease, or worsening of chronic disease) such as: decompensated heart failure, respiratory failure, recent myocardial infarction, shock., For metformin/placebo group: Women of childbearing potential (WOCBP), For all: Current or past use of medications for AD or related diseases (e.g., cholinesterase inhibitors, memantine, aducanumab)., For all: Diminished decision-making capacity, not capable of consenting or completing study assessments, based on clinical judgement., For all: Other known significant neurologic disease (including e.g., Parkinson’s disease, Huntington’s disease, normal pressure hydrocephalus, brain tumour, progressive, supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma with persistent neurologic sequelae or known structural brain abnormalities)., For all: Any other condition affecting safe engagement in the intervention (e.g., malignant disease, major depression, symptomatic cardiovascular disease, revascularisation within the previous year), For all: Severe loss of vision, hearing, or communicative ability; conditions preventing cooperation, For all: Coincident participation in the active phase of another intervention trial., For all: A member of the household already enrolled in the MET-FINGER trial, For metformin/placebo group: Use of metformin for any indication.
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