Clinical Trial

LETHE-AT: a Personalized Multidomain Lifestyle Intervention for Individuals at Increased Risk of Memory Impairment.

Study acronym: LETHE-AT
Not Yet Recruiting
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Summary
The goal of this clinical trial is to learn whether a hybrid multidomain lifestyle program can prevent cognitive decline and reduce dementia risk in community-dwelling adults in mid- to late life who are at increased risk of Alzheimer´s disease or related dementias but do not yet have significant cognitive impairment. The main question the study aims to answer are: * Whether the structured hybrid multidomain lifestyle intervention is feasible (e.g., adherence and retention rate), and how well the digital components are accepted and implemented in the intervention group. * Does the intervention reduces the overall burden of modifiable dementia risk factors and improves global cognitive performance compared with usual care. Researchers will compare participants assigned to the tailored hybrid multidomain lifestyle intervention group with those in a self-guided multimodal lifestyle advice group. Participants assigned to the intervention group will receive a plan adjusted to their individual dementia risk profile. A physician trained in motivational interviewing will review their progress continuously. The self-guided multimodal lifestyle advice group will receive rigid but comprehensible lifestyle health advice with reduced access to digital support tools. Participants will: * Complete an initial risk assessment that uses machine-learning triage to identify and prioritize their most important modifiable dementia risk factors. * Receive personalized recommendations for gradual lifestyle change, including physical activity, nutrition, cognitive training, other dementia risk-factor management (e.g. hearing impairment), stress \& sleep management, and social activities. * Use a smartphone and smartwatch to passively collect digital biomarkers and to complete questionnaires at regular intervals, so that physicians trained in motivational interviewing can adapt goals through shared decision making. * Use a study app as the central access point for the program, including educational content, progress tracking, and gamified challenges with social comparison and incentives.
Trial Details
NCT Number NCT07376135
Lead Sponsor Medical University of Vienna
Collaborators: Medical University of Graz, FH Joanneum Gesellschaft mbH, Medical University Innsbruck, Austrian Research Promotion Agency
Conditions Mild Cognitive Impairment (MCI), Subjective Cognitive Decline (SCD)
Enrollment 300 participants
Start Date 2026-01-08
Primary Completion 2027-10-01 (estimated)
Study Completion 2027-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-01-29