[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621862":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":93,"collaborators":96,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":115,"sex":116,"minAge":117,"maxAge":118,"enrollmentInfo":119,"targetDuration":25,"studyType":122,"phases":123,"briefSummary":125,"conditions":126,"keywords":129,"overallStatus":159,"whyStopped":25,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":169},{"fullName":5,"class":6},"Medical University of Vienna","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"A self-guided multimodal lifestyle advice group","SHAM_COMPARATOR","Participants in the control arm receive a self-guided lifestyle advice programme via the LETHE-AT app and smartwatch, with standardized information across all lifestyle domains but without motivational interviewing, structured coaching or algorithm-based personalization.",[13],"Behavioral: Self-guided multimodal lifestyle advice group",{"label":15,"type":16,"description":17,"interventionNames":18},"A tailored hybrid multidomain lifestyle intervention group","ACTIVE_COMPARATOR","Participants in the intervention arm receive an MI-guided hybrid multidomain lifestyle intervention that integrates AI-based risk profiling, personalized goal setting and structured telehealth coaching with app- and smartwatch-supported self-management across six lifestyle domains.",[19],"Behavioral: A tailored hybrid multidomain lifestyle intervention group",[21,26],{"type":22,"name":15,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","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.",[15],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"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.",[9],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Niklas Rast","CONTACT","+4915154733860","niklas.rast@meduniwien.ac.at",[37,61,78],{"facility":38,"status":25,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Medical University of Innsbruck","Graz","Styria","8010","Austria","AT",{"type":45,"coordinates":46},"Point",[47,48],15.44197,47.06733,{"lat":48,"lon":47},[51,55,58],{"name":52,"role":33,"phone":53,"phoneExt":25,"email":54},"Stephan Seiler, MD PhD","+43 316 385 83396","stephan.seiler@medunigraz.at",{"name":56,"role":57,"phone":25,"phoneExt":25,"email":25},"Stephan Seiler, Md PhD","PRINCIPAL_INVESTIGATOR",{"name":59,"role":60,"phone":25,"phoneExt":25,"email":25},"Marko Stijic, M.Sc.","SUB_INVESTIGATOR",{"facility":38,"status":25,"city":62,"state":63,"zip":64,"country":42,"countryCode":43,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Innsbruck","Tyrol","6020",{"type":45,"coordinates":66},[67,68],11.39454,47.26266,{"lat":68,"lon":67},[71,75,76],{"name":72,"role":33,"phone":73,"phoneExt":25,"email":74},"Atbin Djamshidian-Tehrani, MD PhD","+4351250424239","atbin.djamshidian-tehrani@i-med.ac.at",{"name":72,"role":57,"phone":25,"phoneExt":25,"email":25},{"name":77,"role":60,"phone":25,"phoneExt":25,"email":25},"Livia Scanferla, M.Sc.",{"facility":5,"status":25,"city":79,"state":25,"zip":25,"country":42,"countryCode":43,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Vienna",{"type":45,"coordinates":81},[82,83],16.37208,48.20849,{"lat":83,"lon":82},[86,89,91],{"name":87,"role":33,"phone":88,"phoneExt":25,"email":35},"Niklas Rast MD","+49 1515 47 33 860",{"name":90,"role":57,"phone":25,"phoneExt":25,"email":25},"Elisabeth Stögmann, MD PhD",{"name":92,"role":60,"phone":25,"phoneExt":25,"email":25},"Niklas Rast, MD",{"type":57,"investigatorFullName":94,"investigatorTitle":95,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Elisabeth Stögmann","Physician Investigator",[97,99,102,104],{"name":98,"class":6},"Medical University of Graz",{"name":100,"class":101},"FH Joanneum Gesellschaft mbH","INDUSTRY",{"name":103,"class":6},"Medical University Innsbruck",{"name":105,"class":106},"Austrian Research Promotion Agency","OTHER_GOV","100621862","lethe-at-a-personalized-multidomain-lifestyle-intervention-for-individuals-at-increased-risk-of-memory-impairment-100621862",false,"NCT07376135","LETHE-AT: a Personalized Multidomain Lifestyle Intervention for Individuals at Increased Risk of Memory Impairment.","Digitally Supported Lifestyle Programme to Promote Brain Health Among Older Adults - the LETHE-AT Randomised-controlled, Multicentre Pilot Trial","LETHE-AT","Inclusion Criteria:\n\n* Age between 55 and 75 years at the time of screening.\n* Fluency in German.\n* All participants must be able and willing to provide written informed consent form (ICF) prior to any study-related procedures.\n* Ownership of a compatible Android smartphone, or willingness and capability to use a study-provided Android smartphone for the duration of the study.\n* Subjective cognitive decline and\u002For a positive first-degree family history of dementia.\n* 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.\n* Cognitive performance at or slightly below age expectations, defined as an m-TICS (modified Telephone Interview for Cognitive Status) score ≥ 37\u002F50, and a Montreal Cognitive Assessment (MoCA) ≥ 26\u002F30.\n\nExclusion Criteria:\n\n* Diagnosed or suspected dementia or substantial cognitive impairment, defined as an m-TICS score ≤ 36 or MoCA \\\u003C 26, or current or previous use of Alzheimer´s disease or other dementia medication.\n* 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.\n* 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.\n* Severe impairment of vision, hearing, or communication abilities that would preclude participation in study procedure.\n* 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.\n* Current participation in another interventional trial, unless the study team determines this does not interfere with participation in the LETHE-AT.",true,"ALL","55 Years","75 Years",{"count":120,"type":121},300,"ESTIMATED","INTERVENTIONAL",[124],"NA","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.\n\nThe main question the study aims to answer are:\n\n* 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.\n* Does the intervention reduces the overall burden of modifiable dementia risk factors and improves global cognitive performance compared with usual care.\n\nResearchers will compare participants assigned to the tailored hybrid multidomain lifestyle intervention group with those in a self-guided multimodal lifestyle advice group.\n\nParticipants 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.\n\nThe self-guided multimodal lifestyle advice group will receive rigid but comprehensible lifestyle health advice with reduced access to digital support tools.\n\nParticipants will:\n\n* Complete an initial risk assessment that uses machine-learning triage to identify and prioritize their most important modifiable dementia risk factors.\n* 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.\n* 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.\n* 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.",[127,128],"Mild Cognitive Impairment (MCI)","Subjective Cognitive Decline (SCD)",[130,131,132,42,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158],"dementia prevention","brain health","multidomain lifestyle intervention","multicenter","subjective cognitive decline","physical activity","cognitive training","wearable","smartwatch","App","risk reduction","randomized controlled trial","hybrid digital","dietary counselling","sleep","stress management","ANU-ADRI","LIBRA2","Neuropsychological Test Battery (NTB)","telemedicine","Alzheimer Disease","Cognition Disorders","mild cognitive impairment","multimodal intervention","multicomponent intervention","motivational interviewing","health coaching","mHealth","eHealth","NOT_YET_RECRUITING","2026-01-21",{"date":162,"type":163},"2026-01-29","ACTUAL",{"date":165,"type":121},"2026-01-08",{"date":167,"type":121},"2027-11-01",{"name":5,"class":6},3]