Multimodal preventive trial for Alzheimer’s disease (MIND‐ADMINI): Pilot trial progress and results

Abstract

AbstractBackgroundInterventions simultaneously targeting multiple risk factors are most likely to prevent neurocognitive disorders. This was demonstrated in the 2‐year Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER). However, the feasibility and effects of multimodal interventions in individuals at an early symptomatic disease stage (prodromal AD) are unclear. The objective of the MIND‐AD trial was to evaluate the feasibility of an adapted FINGER‐based multimodal lifestyle intervention, with or without medical food, among individuals with prodromal AD.MethodsMIND‐ADMINI is a multinational proof‐of‐concept 6‐month randomized controlled trial (RCT, ClinicalTrials.gov NCT03249688), with four trial sites (Sweden, Finland, Germany, France). The target population is individuals with prodromal AD using the International Working Group‐1 criteria and vascular and/or lifestyle‐related risk factors. The parallel‐group RCT includes three arms: 1) multimodal lifestyle/vascular intervention (diet, exercise, cognitive training and social stimulation, vascular/metabolic risk management); 2) multimodal lifestyle/vascular intervention+medical food (Fortasyn Connect); 3) regular health advice/care (control group). Primary outcomes: feasibility and adherence. Secondary outcomes: adherence to the individual intervention domains and healthy lifestyle changes,ResultsScreening began September 2017 and was completed May 2019 in all four countries. Altogether, 93 participants were randomized, and the 6‐month intervention was completed December 2019. Electronic data entry and processing was completed December 2020 (delays due to Covid‐19). The mean (SD) age of the entire sample was 72.9 years, education level was 12.8 years, and MMSE score 27.6 points. Vascular and lifestyle‐related risk factors were expected based on the inclusion criteria. Impaired fasting glucose (≥ 6,1 mmol/L) was seen in 29%, and 40% were overweight, with BMI ≥25 and, 12% had BMI ≥30. The intervention proceeded as planned and the preliminary results and participant experiences are positive, supporting the feasibility. Detailed results will be presented, and lessons learned will be discussed.ConclusionsFor the first time, MIND‐AD tests the feasibility of and adherence to a multimodal lifestyle intervention, alone or combined with medical food, among individuals with prodromal AD. The positive intervention experiences are important for this patient group currently lacking effective treatments. The trial also offers a model for pharmacological/non‐pharmacological combination therapies and informs larger efficacy prevention trials.