2022-500438-27-01招募中2 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.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Composite z- score of an extended Neuropsychological Test Battery (NTB) adapted from the FINGER trial
研究概览
简要总结
To test the effect of the 24-month FINGER 2.0 multimodal lifestyle-based intervention (structured multimodal intervention, active arm) versus a self-guided multimodal intervention (control / comparator arm) on change in cognition in an APOE ε4-enriched older population with increased dementia risk
研究设计
- 分配方式
- Randomized
- 主要目的
- Metformin vs. placebo
- 盲法
- Double (Investigator, Subject, Monitor, Analyst)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
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.
结局指标
主要结局
Composite z- score of an extended Neuropsychological Test Battery (NTB) adapted from the FINGER trial
Composite z- score of an extended Neuropsychological Test Battery (NTB) adapted from the FINGER trial
次要结局
- Composite z-scores for NTB memory, executive function, and processing speed domains (based on FINGER)
- Clinical Dementia Rating Sum of Boxes, Instrumental Activities of Daily Living
- Healthy Lifestyle Index, a composite score based on exercise, diet, lifestyle cardiovascular risk factors, and social and cognitive activity
- BMI, waist, waist/hip ratio, blood pressure, lipid profile and glucose metabolism
- Incident cardiovascular disease (e.g., myocardial infarction, angina pectoris, transient ischaemic attack, stroke, peripheral artery disease)
- FINGER healthy diet index, nutrients and food intake
- Self-reported and objectively measured levels of physical activity
- Short Physical Performance Battery, hand grip strength, and timed 10-meter dual-task test
- Center for Epidemiological Studies-Depression Scale
- Perceived Stress Scale
- Insomnia Severity Index
- RAND36 and 15D scales for health-related quality of life
- Self-reported and register data for utilisation of healthcare resources
研究者
MET-FINGER information desk
Scientific
Imperial College London
研究点 (2)
Loading locations...
相似试验
招募中
1 期
A clinical trial to test a combination of lifestyle-based intervention with metformin in preventing dementia.Older adults with risk factors for dementia but dementia free and without substantial cognitive impairment. The intervention is aimed at preventing cognitive decline/dementia.MedDRA version: 20.0Level: HLGTClassification code: 10012272Term: Dementia and amnestic conditions Class: 10037175MedDRA version: 20.0Level: LLTClassification code: 10036654Term: Prevention Class: 10042613MedDRA version: 21.1Level: LLTClassification code: 10009846Term: Cognitive impairment Class: 10029205CTIS2022-500438-27-01Imperial College London600
招募中
不适用
A Feasibility Study of Optimal Non-Pharmacological Lifestyle Modifications in People With Type 2 DiabetesType 2 DiabetesNCT07262788Steno Diabetes Center Copenhagen24
招募中
2 期
Time restricted Eating And Metformin (TEAM) in invasive breast cancer (IBC) or ductal carcinoma in situ (DCIS). A randomized, phase IIb, window of opportunity presurgical trial.2024-518402-40-00Ente Ospedaliero Ospedali Galliera Di Genova90
已完成
不适用
Effectiveness of Metformin and Lifestyle Interventions as Initial Treatment in Japanese Patients with Type 2 Diabetes (EMINENT Study)Type 2 DiabetesJPRN-UMIN000004193issay Hospital20
尚未招募
不适用
Remission of Diabetes With Lifestyle Intervention for Malaysian PatientsObesityType 2 DiabetesNCT07270068Winnie Chee Siew Swee92