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)

Not Applicable

• Conditions: Dementia in Alzheimer disease; F06.7; Mild cognitive disorder

• Registration Number: DRKS00034475
• Lead Sponsor: Cogthera GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-03
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

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)
7) Ability to understand instructions in German language
8) Having access to the Internet and an e-mail address
9) Ability to provide written informed consent
10) Willingness and ability to comply with all aspects of the clinical trial protocol
11) Patients receiving no dementia specific medication at the time of inclusion or patients on a stable dose of dementia specific medication for at least 12 weeks prior to inclusion

Exclusion Criteria

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
the clinical trial
d) Visual field defects that, in the opinion of the investigator, will probably impede the ability to use the intervention or the participation in the clinical
trial
e) Severe aphasia that, in the opinion of the investigator, will probably impede the ability to use the intervention or the participation in the clinical trial

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of cognitive abilities measured with the Demenz-Detektions-Test (DemTect versions A/B)

Secondary Outcome Measures

Name	Time	Method
Improvement of cognitive abilities (Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog versions A/B)), quality of life (Dementia Quality of Life measure (DEMQOL)), and patient autonomy (Patient Activation Measure (PAM13-D)).