LETHE ‐ A digitally supported multimodal lifestyle program to promote brain health among older adults: Study design, progress, and first results
Authors: Rosenberg Anna , Untersteiner Helena , Guazzarini Anna Giulia , Bödenler Markus , Bruinsma Jeroen , Schnalzer Bianca , Colombo Matteo , Crutzen Rik , Diaz Ana , Fotiadis Dimitrios , Hilberger Hannes , Huber Simone , Kaartinen Nico , Kivipelto Miia , Lehtisalo Jenni , Loukas Vassilis , Lötjönen Jyrki , Pirani Mattia , Thunborg Charlotta , Hanke Sten , Mangialasche Francesca , Mecocci Patrizia , Stögmann Elisabeth , Ngandu Tiia ,   LETHE consortium
Published: January 2025

Background

The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) multimodal lifestyle intervention yielded cognitive and other health benefits in older adults at risk of cognitive decline. The two‐year multinational randomized controlled LETHE trial evaluates the feasibility of a digitally supported, adapted FINGER intervention among at‐risk older adults. Technology is used to complement in‐person activities, for the intervention delivery, personalize recommendations, and collect digital biomarkers.

Method

Trial includes older adults (60‐77 years) with digital readiness and increased dementia risk but without substantial cognitive impairment. Participants are enrolled at four sites (Austria, Finland, Italy, Sweden). At baseline, participants were randomized 1:1 ratio to 1) intervention i.e., structured multimodal lifestyle program (including diet, exercise, cognitive training, vascular/metabolic risk management, social stimulation, sleep/stress management) where in‐person activities led by professionals are supported with an Android mobile phone application developed by the consortium (the LETHE App); or 2) control i.e., self‐guided program (regular health advice, simplified App with no personalized/interactive content). All participants wear smartwatches to gather passive data (e.g., physical activity, sleep). Primary outcomes are retention, adherence, and change in validated dementia risk scores. Secondary outcomes include changes in lifestyle, cognition, stress, sleep, health‐related quality of life, health literacy. Additional outcomes (exploratory) include e.g., participant experiences and dementia‐related biomarkers (Alzheimer’s disease blood markers, neuroimaging). A sub‐study explores the feasibility of novel interactive technology (audio glasses, social robot).

Results

Recruitment began in September 2022, and the last participant was randomized in June 2023. In total, 156 individuals were randomized (mean age 69 years, 65% women; balanced recruitment across the four sites). Vascular and lifestyle risk factors were common (e.g., 65% with hypertension, 69% with hypercholesterolemia, 39% physically inactive), indicating successful recruitment of a population with risk reduction potential. Trial will be completed by summer 2025. Retention until the first post‐baseline visit at 6 months is high (n = 2 discontinued, retention 98.7%). Latest progress of the trial will be presented.

Conclusion

LETHE provides crucial information about the feasibility of technology and a digitally supported FINGER program to promote brain health. Digital tools specifically designed for older adults could offer potential for large‐scale, cost‐effective prevention programs.