F06.7 F00 F01
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Diagnosis (confirmed by a specialist): either mild cognitive impairment (F06.7) or mild dementia (F00, F01) - For MCI: MoCA scores of 21–24 - For mild dementia: MoCA scores 14–20 - Access to a smartphone or tablet with an internet connection - Ability to use smartphone apps of moderate complexity (e.g. WhatsApp, email, internet browser, etc.) - Ability to understand, read and write German - Age > 18 years
Exclusion criteria
Exclusion criteria: - Any uncontrolled medical or neurological/neurodegenerative condition (other than MCI/ dementia) during the past 12 months that, in the opinion of the investigator, might be a contributing cause of the subject’s cognitive impairment (e.g., malignant disease, severe depression, substance abuse, vitamin B12 deficiency, abnormal thyroid function, acute stroke, head trauma) - Severe sensory impairment (vision, hearing) that makes app usage impossible - History or active / planned usage of comparable digital therapeutics - Other circumstances that make app usage impossible (e.g. planned surgery or cardiovascular intervention) - Any medications that, in the opinion of the investigator, may contribute to cognitive impairment, impair the subject’s ability to perform cognitive testing or complete study procedures. - If on prescribed medication for dementia: dosage has to be constant for 8 weeks for Gingko biloba and 4 weeks for Acetylcholinesterase-inhibitors and Anti-amyloid antibodies before inclusion in the study and/or planned change of dosage or medication regimen during the course of the study interval
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cognitive abilities (MoCA, Montreal Cognitive Assessment) Assessment: baseline at study start and follow-up after 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| (Instrumental) Activities of daily living (Amsterdam iADL) Quality of life (Demqol, Dementia quality of life) | — |
Countries
Germany
Contacts
NeuroMed Campus