NCT07376135 · NOT YET RECRUITING
LETHE-AT: a Personalized Multidomain Lifestyle Intervention for Individuals at Increased Risk of Memory Impairment.
This trial is testing whether a personalized, technology-assisted lifestyle program — covering exercise, diet, sleep, cognitive training, and social activity — can slow cognitive decline in adults aged 55 to 75 who are at higher-than-average dementia risk but still cognitively healthy. It compares a coached, app-based intervention against basic self-guided advice. This is a Phase NA feasibility and efficacy study — meaning researchers are still learning whether the approach works and can be delivered reliably.
You may qualify if
- 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.
You're excluded if
- 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-01-29