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.
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.
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.
Parallel
A tailored hybrid multidomain lifestyle intervention group
BehavioralThe 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.
Self-guided multimodal lifestyle advice group
BehavioralParticipants 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.
Operational feasibility: retention rate
Proportion of all randomized participants who complete the Month 18 assessment in each trial arm (percentage of all randomized participants; higher percentage = better retention).
Operational feasibility: adherence to the structured hybrid lifestyle intervention
Composite adherence score combining attendance at workshops and telehealth sessions, engagement with the LETHE-AT app (logins and completed modules), and proportion of days with successful smartwatch data uploads (higher values = better adherence).
Change in health-related quality of life (SF-36)
Change in health-related quality of life assessed with the 36-Item Short Form Health Survey (SF-36; 0-100 points per domain; higher scores = better self-reported health status).
Change in health literacy (HLS-EU-Q16)
Change in health literacy assessed with the European Health Literacy Survey Questionnaire, 16-item version (HLS-EU-Q16; 0-16 points; higher scores = better general health literacy).
User acceptance of the digital solution (SUS)
Change in perceived usability of the app and digital devices assessed with the System Usability Scale (SUS; 0-100 points; higher scores = better perceived usability and acceptance).
Change in perceived stress (PSS-14)
Change in perceived stress assessed with the Perceived Stress Scale-14 (PSS-14; 0-56 points; higher scores = more perceived stress during the past month).
Change in global cognition assessed with the modified Neuropsychological Test Battery (mNTB)
All test raw scores are converted to z-scores (baseline mean = 0, SD = 1, with sign reversal where lower times indicate better performance): Wechsler Memory Scale - Fourth Edition (WMS-IV) Logical Memory (immediate and delayed recall, recognition) Rey Auditory Verbal Learning Test (RAVLT / VLMT; list learning, immediate and delayed recall, recognition) Rey-Osterrieth Complex Figure Test (copy, 3-minute and 30-minute delayed recall) Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Digit Span (forward, backward, sequencing) Test of Attentional Performance (TAP) - Alertness Test of Attentional Performance (TAP) - Divided Attention WAIS-IV Digit Symbol Substitution Test (DSST) Trail Making Test (TMT) Part A Trail Making Test (TMT) Part B (shitime B-A) Regensburg Word Fluency Test (semantic: animals; phonemic: letter P) Colour-Word Interference Test (German Stroop; colour naming, word reading, interference condition)
Change in dementia risk: LIBRA2
Change in dementia risk estimated with the Lifestyle for Brain Health index (LIBRA2; theoretical range -5.9 to +12.7; higher scores = less healthy lifestyle and higher estimated dementia risk).
Change in dementia risk: ANU-ADRI
Change in dementia risk estimated with the Australian National University Alzheimer's Disease Risk Index (ANU-ADRI; theoretical range approximately -13 to +64; higher scores = higher estimated Alzheimer's disease risk).
Change in physical activity (German-PAQ)
Change in self-reported physical activity assessed with the Short German Physical Activity Questionnaire (German-PAQ; minutes per week of moderate-to-vigorous activity; higher values = more physical activity).
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Medical University of Vienna
Lead sponsor
Medical University of Graz
Collaborator
FH Joanneum Gesellschaft mbH
Collaborator
Medical University Innsbruck
Collaborator
Austrian Research Promotion Agency
Collaborator
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