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NOT YET RECRUITING

NCT07376135

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

Sponsor: Medical University of Vienna

View on ClinicalTrials.gov

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.

Official title: Digitally Supported Lifestyle Programme to Promote Brain Health Among Older Adults - the LETHE-AT Randomised-controlled, Multicentre Pilot Trial

Key Details

Gender

All

Age Range

55 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-01-08

Completion Date

2027-11-01

Last Updated

2026-01-29

Healthy Volunteers

Yes

Conditions

Mild Cognitive Impairment (MCI)Subjective Cognitive Decline (SCD)

Interventions

BEHAVIORAL

A tailored hybrid multidomain lifestyle intervention group

The structured counselling intervention combines interactive face-to-face workshops with ongoing remote coaching through the LETHE-AT mobile app and regular (video)-telephone sessions to support sustained lifestyle changes. Each participant is individually guided throughout the intervention by a dedicated coach (physician or psychologist), trained in motivational interviewing techniques aimed at facilitating behavioural changes across targeted lifestyle domains.

BEHAVIORAL

Self-guided multimodal lifestyle advice group

Participants receive a reduced version of the LETHE-AT app with general health information only. No structured in-person or remote counselling is provided and no individualized digital content is unlocked. They are encouraged to implement lifestyle changes independently. Throughout the trial, participants complete the same in-app questionnaires, wear a Garmin Vivosmart 5, and receive routine laboratory result with advice to seek certain medical care if needed. A pure no-treatment arm is not included for ethical reasons.

Inclusion Criteria: * Age between 55 and 75 years at the time of screening. * Fluency in German. * All participants must be able and willing to provide written informed consent form (ICF) prior to any study-related procedures. * Ownership of a compatible Android smartphone, or willingness and capability to use a study-provided Android smartphone for the duration of the study. * Subjective cognitive decline and/or a positive first-degree family history of dementia. * Willingness to make meaningful changes in at least three of six lifestyle domains: dietary counselling, physical activity, cognitive training, vascular risk management, social interaction, and sleep and relaxation. * Cognitive performance at or slightly below age expectations, defined as an m-TICS (modified Telephone Interview for Cognitive Status) score ≥ 37/50, and a Montreal Cognitive Assessment (MoCA) ≥ 26/30. Exclusion Criteria: * Diagnosed or suspected dementia or substantial cognitive impairment, defined as an m-TICS score ≤ 36 or MoCA \< 26, or current or previous use of Alzheimer´s disease or other dementia medication. * Significant neurological disease, including but not limited to Parkinson´s disease, Huntington´s disease, normal pressure hydrocephalus, brain tumour, progressive supranuclear palsy, seizure disorder, subdural haematoma, multiple sclerosis, or a history of significant head trauma with persistent neurological sequelae or known structural brain abnormalities. * Diminished decision-making capacity, inability to provide informed consent, inability to complete study assessments, or any condition preventing effective cooperation, as determined by clinical judgement. * Severe impairment of vision, hearing, or communication abilities that would preclude participation in study procedure. * Any medical or psychiatric condition affecting safe engagement, including but not limited to active malignancy, major depressive disorder, symptomatic cardiovascular disease, or revascularisation procedures within the past year. * Current participation in another interventional trial, unless the study team determines this does not interfere with participation in the LETHE-AT.

Locations (3)

Medical University of Innsbruck

Graz, Styria, Austria

Medical University of Innsbruck

Innsbruck, Tyrol, Austria

Medical University of Vienna

Vienna, Austria