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Japan-multimodal intervention trial for the prevention of dementia: a randomized controlled trial [with consumer summary]
Sakurai T, Sugimoto T, Akatsu H, Doi T, Fujiwara Y, Hirakawa A, Kinoshita F, Kuzuya M, Lee S, Matsumoto N, Matsuo K, Michikawa M, Nakamura A, Ogawa S, Otsuka R, Sato K, Shimada H, Suzuki H, Suzuki H, Takechi H, Takeda S, Uchida K, Umegaki H, Wakayama S, Arai H
Alzheimer's & Dementia 2024 Jun;20(6):3918-3930
clinical trial
6/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

INTRODUCTION: We examined the efficacy of a multidomain intervention in preventing cognitive decline among Japanese older adults with mild cognitive impairment (MCI). METHODS: Participants aged 65 to 85 years with MCI were randomized into intervention (management of vascular risk factors, exercise, nutritional counseling, and cognitive training) and control groups. The primary outcome was changes in the cognitive composite score over a period of 18 months. RESULTS: Of 531 participants, 406 completed the trial. The between-group difference in composite score changes was 0.047 (95% CI -0.029 to 0.124). Secondary analyses indicated positive impacts of interventions on several secondary health outcomes. The interventions appeared to be particularly effective for individuals with high attendance during exercise sessions and those with the apolipoprotein E epsilon4 allele and elevated plasma glial fibrillary acidic protein levels. DISCUSSION: The multidomain intervention showed no efficacy in preventing cognitive decline. Further research on more efficient strategies and suitable target populations is required.

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