Digitally Supported Lifestyle Programme to Promote Brain Health Among Older Adults - the LETHE Pilot Trial
Sponsor: Finnish Institute for Health and Welfare
Trial Details
| Condition | Cognitive Impairment, Cognitive Decline, Dementia |
| Intervention | Structured ICT-assisted multimodal lifestyle intervention; Self-guided multimodal lifestyle intervention |
| Phase | NA |
| Status | Completed |
| Participants | 156 |
| Est. Completion | 12 May 2025 |
| Last Updated | 26 May 2026 |
Primary Outcome
Feasibility: retention rate; Feasibility: adherence to the structured multimodal lifestyle intervention; Change in dementia risk scores (LIBRA and CAIDE), units on a scale
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
Trial Sites
🇦🇺 Australian Sites (1)
Countries
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