Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07376135
Eligibility Criteria:
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
75 Years
Study:
NCT07376135
Study Brief:
Protocol Section:
NCT07376135