Multidisciplinary Lifestyle Interventions for Neurological Disorders During the Silent Phase (MINDS) Study: An Exploratory, Multiomics Randomized Controlled Trial
Seerat Sachdeva1, Joe James2, Sara Taylor2, Anthony Lioi2, Iris Petschek2, Sandra Darling2, Imad Najm2, Vineet Punia2
1Dr. S N Medical College, India ; Cleveland Clinic, Ohio, 2Cleveland Clinic, Ohio
Objective:
To report an open-label, randomized control trial (RCT) protocol investigating multidisciplinary lifestyle interventions (MLI) among neurologically healthy older adults (≥50 years) during prodromal stages of common neurological disorders.
Background:

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.

Design/Methods:

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.

Results:
MINDS has enrolled 49 participants (25% of the target; 50.5% of eligible participants), with a goal to complete enrollment by the end of 2024 second quarter. Nearly 70% have severe hyposmia, a PD risk factor. The first intervention cohort (n = 7) finished their 12-week sessions.
Conclusions:

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.


10.1212/WNL.0000000000206048