Precision Medicine Approach to Alzheimer's Disease: Successful Pilot Project.
Level 4 - case-series / case-control
Uncontrolled single-arm prospective pilot study (RCT indexing in pub_types appears incorrect based on abstract description)
PubMed 35811518 · doi:10.3233/JAD-215707
What was done
Twenty-five patients with dementia or mild cognitive impairment and Montreal Cognitive Assessment (MoCA) scores of 19 or higher were evaluated for metabolic, infectious, toxic, inflammatory, hormonal, vascular, and nutrient factors. Brain magnetic resonance imaging with volumetrics was conducted at baseline and at 9 months. Patients received a personalized precision medicine protocol for 9 months, with cognition assessed at 0, 3, 6, and 9 months.
What was found
The authors report statistically significant improvements across all outcome measures, specifically MoCA scores, CNS Vital Signs Neurocognitive Index, Alzheimer's Questionnaire Change score, and MRI volumetrics. No serious adverse events were recorded. The abstract reports no numerical values, baseline scores, effect sizes, confidence intervals, or exact p-values.
Why it matters
This study provides preliminary proof-of-concept data for a personalized multi-target intervention targeting heterogeneous contributors to cognitive decline.
Limits
The study is a small (n = 25), uncontrolled, open-label pilot with no control group, making it impossible to rule out practice effects, regression to the mean, or placebo effects. The abstract contains zero quantitative outcome data.
Cited by
- supports A 9-month proof-of-concept trial of the Bredesen protocol showed that approximately 80% of patients improved in cognitive measures including MoCA, CNS Vital Signs, and AQ-C scores, and had better MRI volume outcomes than typical decline.
- supports In a clinical trial testing a multi-modal protocol for cognitive decline conducted by Dale Bredesen, Kat Toups, Ann Hathaway, and Deborah Gordon, the vast majority of participants showed clinical improvement.