Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cognitive Impairment
- Sponsor
- Finnish Institute for Health and Welfare
- Enrollment
- 1200
- Locations
- 4
- Primary Endpoint
- Cognitive impairment assessed with a Neuropsychological Test Battery, and Stroop and Trail Making tests.
- Status
- Active, Not Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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).
Investigators
Miia Kivipelto
Professor
Finnish Institute for Health and Welfare
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Cognitive impairment assessed with a Neuropsychological Test Battery, and Stroop and Trail Making tests.
Time Frame: 2 years
Secondary Outcomes
- 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)