With our aging population, neurological disorders are on the rise, leading to higher healthcare costs and disability rates. Identifying pre-clinical biomarkers is crucial, as is finding ways to slow or reverse pathology during this phase. Previous lifestyle interventions have shown inconsistent results due to poor subject selection and the absence of early-response biomarkers. The ongoing MINDS study aims to explore these biomarkers to inform future biomarker discovery validation studies.

The MINDS study (NCT05984056) enrolls older adults ‘at risk’ of stroke, dementia, Parkinson's disease (PD), and epilepsy from the Cleveland Clinic Brain Study (CCBS). The ‘at risk’ criterion is based on literature review and balances high specificity and prevalence. Participants are randomized to 'intervention' or 'control observation' groups (n = 100 each). The intervention group undergoes 12 weekly online sessions of 2 hours each (diet, yoga, music therapy, and cognitive training). Evaluations include clinical assessments, neuropsychological tests, MRI, PSG with overnight EEG, ocular coherence tomography and multiomics (whole genome seq, proteomics, transcriptomics, and metabolomics, including gut-microbiome RNAseq). The primary outcome is pathological progression. A structured interview format will be utilized to generate qualitative data on online MLI challenges, which will inform future research and clinical work.

The MINDS study explores MLI in 'at-risk' older adults, providing data for future proof-of-concept studies on pre-clinical and MLI responsiveness biomarkers.