A randomized controlled pilot trial to evaluate the effectiveness and safety of a memory-supporting digital intervention for adult patients with Mild Cognitive Impairment (MCI) and Mild Alzheimer's Dementia (AD) - M3 trial

Cogthera GmbH0 sites140 target enrollmentJuly 3, 2024

Overview

No summary available.

Registry

who.int

Start Date

July 3, 2024

End Date

TBD

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

Cogthera GmbH

•1\) Age \= 50 years
•2\) Prevalent diagnosis of:
•MCI (ICD\-10: F06\.7\) to be eligible for Cohort 1, or
•AD (ICD\-10: F00\.\-\*) to be eligible for Cohort 2
•3\) Mini\-Mental State Examination (MMSE) Score 20 \= to \= 27 in the assessment carried out as part of the screening process or in a professional assessment carried out no more than 14 days prior to the screening visit
•4\) Appropriated visual and auditory functions and standard speaking German required for the execution of the intervention and the clinical trial
•5\) Possession of an own mobile device with internet connections
•a) For Android smartphones and tablets Android 8 or later
•b) For iPhones and iPads iOS 13 or later
•6\) Ability to use the smartphone, e.g. use E\-Mail on the smartphone, SMS, a messenger (WhatsApp, Telegram, Signal) or a Social Platform (Facebook, Instagram, TikTok)

•12\) Transient ischemic attack, brain tumor, stroke, or seizure within 12 months before study
•13\) Psychiatric symptoms, including: History of diagnosis of other mental disorders than MCI or symptoms that can impede test procedures of the participants (e.g., psychosis or major depressive disorder)
•14\) Nursing Care Grade \= 3
•15\) Pregnancy or planned pregnancy within the next three months
•16\) Clinically important abnormalities, that might contribute to or affect the cognitive performance of the patient, for example:
•a) Abnormal findings in physical examinations, neurological examinations, and vital signs at screening or baseline that, in the opinion of the investigator, may require additional examination or treatment that may interfere with the study procedures or safety
•b) Other medical conditions (e.g., heart, respiratory, gastrointestinal, kidney
•disease) that are not adequately stable controlled, in the investigator's opinion, may affect the safety of the subject or interfere with the evaluation of the trial
•c) Dysarthria or speaking disabilities that, in the opinion of the investigator,
•probably impede the ability to use the intervention or the participation in