F06.7 F00 F01
Conditions
Interventions
Group 1: Intervention group
In addition to standard care: Implementation of an app-based multi-domain intervention with brain training, sports program, nutritional adjustment, optimization of risk fac
Sponsors
memodio GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Diagnosis of either Mild Cognitive Impairment F06.7 or Mild Dementia F00, F01 • For MCI: MoCA Scores 21-25 OR Demtect-Score: 10 - 13 • For Mild Dementia: MoCA-Scores 14-20 OR Demtect-Score: 6-9 • Access to a smartphone or a tablet with internet connection • Ability to use smartphone apps of medium complexity (e.g. Whatsapp, Mail, 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 dementia (MoCa Score <14 OR Demtect-Score <6 OR other scores: according to individual recommendations) • 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 3 months for memantine, 8 weeks for Gingko biloba and 1 month for Acetylcholinesterase-inhibitors 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| (Instrumental) Activities of daily living (Amsterdam iADL) Quality of life (Demqol, Dementia quality of life) Activity level (PAQ50+, Physical Activity Questionnaire in the over-50 Population) | — |
Countries
Germany
Contacts
Public ContactGereon Nelles
NeuroMed Campus
Outcome results
None listed