Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,200
- 试验地点
- 9
- 主要终点
- Cognitive impairment assessed with a Neuropsychological Test Battery, and Stroop and Trail Making tests.
研究概览
简要总结
This multi-center (6 sites: Helsinki, Kuopio, Oulu, Seinäjoki, Turku, Vantaa) intervention study aims to prevent cognitive impairment, dementia and disability in 60-77 year old persons at an increased dementia risk. The 2-year multi-domain life-style intervention includes nutritional guidance, exercise, cognitive training, increased social activity, and intensive monitoring and management of metabolic and vascular risk factors. The primary outcome is cognitive impairment measured by a sensitive Neuropsychological Test Battery (NTB), and Stroop and Trail Making tests to capture early cognitive impairment typical for both Alzheimer's disease and vascular dementia. We hypothesize that the multi-domain intervention will reduce cognitive impairment in the study group compared to the control group during the initial 2-year intervention period and reduce dementia incidence after the extended follow-up (until at least 300 participants have developed dementia).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 60-77 years
- •dementia Risk Score 6 points or more
- •fulfillment of at least one of the following CERAD criteria: i) MMSE: 20-26 points ii) word list memory task (3x10 words): 19 words or less iii) delayed recall: 75% or less
排除标准
- •malignant diseases
- •substantial cognitive decline
- •major depression
- •symptomatic cardiovascular disease
- •revascularisation within 1 year
- •severe loss of vision, hearing or communicative ability
- •other conditions inhibiting from safe engagement in the prescribed intervention as judged by the study physician
- •other conditions preventing from cooperation as judged by the study physician
结局指标
主要结局
Cognitive impairment assessed with a Neuropsychological Test Battery, and Stroop and Trail Making tests.
时间窗: 2 years
次要结局
- Disability will be assessed using the ADCS-ADL scale(2 years)
- Vascular and metabolic risk factors will be assessed with blood pressure and anthropometric measurements, and laboratory analyses of metabolic biomarkers.(2 years)
- Changes in dietary biomarker levels will be assessed through laboratory testing.(2 years)
- Depressive symptoms will be assessed using the Zung depression scale.(2 years)
- Quality of Life will be assessed using the RAND-36 and 15D questionnaires.(2 years)
- Vascular and metabolic morbidity and mortality will be assessed through questionnaire and register data.(2 years)
- Utilization of health resources will be assessed using questionnaire and register data.(2 years)
研究者
Miia Kivipelto
Professor
Finnish Institute for Health and Welfare