期刊
LANCET
卷 385, 期 9984, 页码 2255-2263出版社
ELSEVIER SCIENCE INC
DOI: 10.1016/S0140-6736(15)60461-5
关键词
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资金
- Academy of Finland [120676, 11745, 251645]
- La Carita Foundation
- Alzheimer Association [HAT-10 173121]
- Alzheimer's Research and Prevention Foundation
- Juho Vainio Foundation
- Novo Nordisk Foundation
- Finnish Social Insurance Institution
- Ministry of Education and Culture
- Salama bint Hamdan Al Nahyan Foundation
- Axa Research Fund
- EVO
- Swedish Research Council
- Swedish Research Council for Health, Working Life and Welfare
- af Jochnick Foundation
- Academy of Finland's Responding to Public Health Challenges Research Programme (SALVE) [129395, 129397, 129459, 129421, 129416, 129511, 129401, 259615]
- Axa Research Grant
- EVO of University Hospital of Kuopio
- EVO of University Hospital of Oulu
- EVO of University Hospital of Turku
- EVO of Seinajoki Central Hospital
- EVO of Oulu City Hospital
- Swedish Society for Medical Research
- Saastamoinen Foundation
- Loo och Hans Osterman Foundation
- Stiftelsen Dementia
- Gustaf o Victoria Frimurarestiftelse
- Alexander von Humboldt Research award
- Academy of Finland (AKA) [129401, 129511, 129416, 129421, 129459, 129397, 129401, 129511, 129416, 129421, 129459, 129397] Funding Source: Academy of Finland (AKA)
- Novo Nordisk Fonden [NNF12OC1016402, NNF11OC1014884] Funding Source: researchfish
Background Modifiable vascular and lifestyle-related risk factors have been associated with dementia risk in observational studies. In the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER), a proof-of-concept randomised controlled trial, we aimed to assess a multidomain approach to prevent cognitive decline in at-risk elderly people from the general population. Methods In a double-blind randomised controlled trial we enrolled individuals aged 60-77 years recruited from previous national surveys. Inclusion criteria were CAIDE (Cardiovascular Risk Factors, Aging and Dementia) Dementia Risk Score of at least 6 points and cognition at mean level or slightly lower than expected for age. We randomly assigned participants in a 1: 1 ratio to a 2 year multidomain intervention (diet, exercise, cognitive training, vascular risk monitoring), or a control group (general health advice). Computer-generated allocation was done in blocks of four (two individuals randomly allocated to each group) at each site. Group allocation was not actively disclosed to participants and outcome assessors were masked to group allocation. The primary outcome was change in cognition as measured through comprehensive neuropsychological test battery (NTB) Z score. Analysis was by modified intention to treat (all participants with at least one post-baseline observation). This trial is registered at ClinicalTrials.gov, number NCT01041989. Findings Between Sept 7, 2009, and Nov 24, 2011, we screened 2654 individuals and randomly assigned 1260 to the intervention group (n=631) or control group (n=629). 591 (94%) participants in the intervention group and 599 (95%) in the control group had at least one post-baseline assessment and were included in the modified intention-to-treat analysis. Estimated mean change in NTB total Z score at 2 years was 0.20 (SE 0.02, SD 0.51) in the intervention group and 0.16 (0.01, 0.51) in the control group. Between-group difference in the change of NTB total score per year was 0.022 (95% CI 0.002-0.042, p=0.030). 153 (12%) individuals dropped out overall. Adverse events occurred in 46 (7%) participants in the intervention group compared with six (1%) participants in the control group; the most common adverse event was musculoskeletal pain (32 [5%] individuals for intervention vs no individuals for control). Interpretation Findings from this large, long-term, randomised controlled trial suggest that a multidomain intervention could improve or maintain cognitive functioning in at-risk elderly people from the general population.
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