Effects of intensive lifestyle changes on the progression of mild cognitive impairment or early dementia due to Alzheimer’s disease: a randomized, controlled clinical trial

作者：Dean Ornish, Catherine Madison, Miia Kivipelto, Colleen Kemp, Charles E. McCulloch, Douglas Galasko, J. Sheldon Artz, Dorene M. Rentz, Jue Lin, Kim Norman, Anne Ornish, Sarah Tranter, Nancy DeLamarter, Noel Wingers, Carra Richling, Rima Kaddurah‐Daouk, Rob Knight, Daniel McDonald, Lucas Patel, Eric Verdin, Rudolph E. Tanzi, Steven E. Arnold · 发表于：Alzheimer s Research & Therapy · 年份：2024 · DOI：10.1186/s13195-024-01482-z · 被引用次数：150 · 研究领域：Dementia and Cognitive Impairment Research、Alzheimer's disease research and treatments、Neurological Disease Mechanisms and Treatments

BACKGROUND: Evidence links lifestyle factors with Alzheimer's disease (AD). We report the first randomized, controlled clinical trial to determine if intensive lifestyle changes may beneficially affect the progression of mild cognitive impairment (MCI) or early dementia due to AD. METHODS: A 1:1 multicenter randomized controlled phase 2 trial, ages 45-90 with MCI or early dementia due to AD and a Montreal Cognitive Assessment (MoCA) score of 18 or higher. The primary outcome measures were changes in cognition and function tests: Clinical Global Impression of Change (CGIC), Alzheimer's Disease Assessment Scale (ADAS-Cog), Clinical Dementia Rating-Sum of Boxes (CDR-SB), and Clinical Dementia Rating Global (CDR-G) after 20 weeks of an intensive multidomain lifestyle intervention compared to a wait-list usual care control group. ADAS-Cog, CDR-SB, and CDR-Global scales were compared using a Mann-Whitney-Wilcoxon rank-sum test, and CGIC was compared using Fisher's exact test. Secondary outcomes included plasma Aβ42/40 ratio, other biomarkers, and correlating lifestyle with the degree of change in these measures. RESULTS: Fifty-one AD patients enrolled, mean age 73.5. No significant differences in any measures at baseline. Only two patients withdrew. All patients had plasma Aβ42/40 ratios <0.0672 at baseline, strongly supporting AD diagnosis. After 20 weeks, significant between-group differences in the CGIC (p= 0.001), CDR-SB (p= 0.032), and CDR Global (p= 0.037) tests and borderlin...