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.
Level 2 - randomized trial
Randomized controlled phase 2 clinical trial
PubMed 38849944 · doi:10.1186/s13195-024-01482-z
What was done
A 1:1 multicenter randomized controlled phase 2 trial evaluated 51 patients aged 45–90 years (mean age 73.5) with mild cognitive impairment (MCI) or early dementia due to Alzheimer's disease (AD) and baseline MoCA ≥18. Participants were assigned to 20 weeks of an intensive multidomain lifestyle intervention or a wait-list usual care control group. Primary outcomes were cognitive and functional changes measured by CGIC, ADAS-Cog, CDR-SB, and CDR-Global. Secondary outcomes included plasma Aβ42/40 ratio and microbiome changes.
What was found
Fifty-one patients enrolled and two withdrew. At 20 weeks, significant between-group differences favored the lifestyle intervention for CGIC (p = 0.001), CDR-SB (p = 0.032), and CDR-Global (p = 0.037), with borderline significance for ADAS-Cog (p = 0.053). The intervention group showed improvements on CGIC, CDR-Global, and ADAS-Cog and less progression on CDR-SB, whereas controls worsened on all four measures. Plasma Aβ42/40 ratio increased in the intervention group and decreased in controls (between-group p = 0.003). Microbiome measures improved exclusively in the intervention group (p < 0.0001). Exact numerical test scores and effect sizes were not provided in the abstract.
Why it matters
This randomized trial provides initial evidence that comprehensive lifestyle changes may stabilize or improve cognitive performance and disease biomarkers in early-stage Alzheimer's disease over a 20-week period.
Limits
The study sample was small (n = 51), intervention duration was short (20 weeks) for a progressive neurodegenerative disease, specific intervention components were omitted from the abstract, and trial registration was completed retrospectively.
Cited by
- supports A 20-week trial by Rudolph Tanzi and Dean Ornish in 51 patients with Alzheimer's disease demonstrated that comprehensive lifestyle changes stopped cognitive decline in 70% of participants, with many improving.
- partial Interventional trials using lifestyle modification have proven effective in improving cognitive outcomes in individuals with established Alzheimer's disease.