First Randomized Controlled Trial Showing Non-Pharma Intervention (Lifestyle Changes) Can Help Reduce Alzheimer’s Disease Symptoms

Dean Ornish, M.D., President, Preventive Medicine Research Institute a non-profit in Sausalito, California, and colleagues recently completed a small, but important study published in the journal Alzheimer’s Research and Therapy investigating the links between lifestyle factors and Alzheimer’s disease (AD). A key premise: mounting evidence links lifestyle factors with the onset and progression of dementia, including AD. Elements to consider include unhealthful diets, sedentary living, emotional stress, and social isolation. Enter this first randomized, controlled clinical trial evaluating if intensive lifestyle changes could possibly positively affect the progression of mild cognitive impairment (MCI) or early dementia due to Alzheimer’s disease. Specifically, this 1:1 multicenter randomized controlled phase 2 trial, ages 45-90 with mild cognitive impairment (MCI) or early dementia due to AD and a Montreal Cognitive Assessment (MoCA) score of 18 or higher. Study endpoints include 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 multi-domain lifestyle intervention compared to a wait-list usual care control group. Ornish and colleagues compared ADAS-Cog, CDR-SB, and CDR-Global scales using a Mann-Whitney-Wilcoxon rank-sum test, and CGIC was compared using Fisher’s exact test. Secondary endpoint measures included plasma Aβ42/40 ratio, other biomarkers, and correlating lifestyle with the degree of change in these measures. The authors report comprehensive lifestyle changes in fact may significantly improve cognition and function after only 20 weeks in many patients with MCI or early dementia due to AD, a substantially promising finding.

The Study