NCT05565170 · ACTIVE NOT RECRUITING
Digitally Supported Lifestyle Programme to Promote Brain Health Among Older Adults
This trial tests whether a personalized, app-supported lifestyle program helps protect brain health in older adults who have risk factors for dementia. Participants follow a structured plan covering exercise, diet, sleep, social activity, and vascular risk management — guided partly by a smartphone app — and researchers measure changes in dementia risk scores over 24 months. This is a feasibility and exploratory trial, meaning researchers are still working out whether the approach is practical and promising, not confirming a proven benefit.
You may qualify if
- Age 60-77 years
- Cardiovascular Risk Factors, Aging and Incidence of Dementia (CAIDE) Risk Score ≥ 6 points
- Cognitive performance at the mean level or slightly lower than expected for age, assessed with Mini-Mental State Examination (MMSE) and the Consortium to Establish a registry for Alzheimer's Disease (CERAD) verbal learning test (word list learning/recall)
- Proficiency in the local language (German, Italian, Finnish or Swedish)
- Ability and willingness to use an Android smartphone, access to and ability to use the internet (digital readiness)
- Existing compatible smartphone (Android) or willingness to use a new Android smartphone provided from the study
You're excluded if
- Dementia or substantial cognitive impairment (e.g., memory clinic referral needed as judged by the study physician)
- Current or past use of medications for Alzheimer's disease or related diseases (e.g., cholinesterase inhibitors, memantine)
- Diminished decision-making capacity, not capable of consenting or completing study assessments, based on clinical judgement
- Other significant neurologic disease, including but not limited to Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma with persistent neurologic sequelae or known structural brain abnormalities
- Any condition affecting safe engagement in the intervention, e.g., malignant disease, major depression, symptomatic cardiovascular disease, revascularisation within 1 year previously
- Severe loss of vision, hearing, or communicative ability; conditions preventing cooperation as judged by the study physician
- Concomitant participation in an interventional trial (unless this will not interfere with the LETHE trial based on study staff's judgement)
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 2024-09-25