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MEMODIO_APP@CARE II – Evaluation of the memodio app as part of a prospective, multicentre, two-arm, randomised controlled trial with a parallel-group design in people with mild cognitive impairment and mild dementia

MEMODIO_APP@CARE II – Evaluation of the memodio app as part of a prospective, multicentre, two-arm, randomised controlled trial with a parallel-group design in people with mild cognitive impairment and mild dementia - MEMODIO_APP@CARE II

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00040228
Enrollment
230
Registered
2026-05-06
Start date
2026-05-08
Completion date
Unknown
Last updated
2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F06.7 F00 F01

Interventions

Group 1: Intervention group In addition to treatment as usual: Implementation of an app-based multi-domain intervention with brain training, sports program, nutritional adjustment, optimization of ris

Sponsors

memodio GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

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

MeasureTime frame
Cognitive abilities (MoCA, Montreal Cognitive Assessment) Assessment: baseline at study start and follow-up after 12 weeks

Secondary

MeasureTime frame
(Instrumental) Activities of daily living (Amsterdam iADL) Quality of life (Demqol, Dementia quality of life)

Countries

Germany

Contacts

Public ContactGereon Nelles

NeuroMed Campus

g.nelles@neuromed-campus.de+49 221 943812-0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 29, 2026