Mild cognitive impairment (MCI) Mental and Behavioural Disorders Mild cognitive impairment
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 23/06/2020: 1. Mild cognitive impairment 1.1. Montreal Cognitive Assessment score 55 4. Informed consent given
Exclusion criteria
Exclusion criteria: 1. Completely blind or deaf 2. No personal computer, laptop or tablet 3. Normal cognition, Montreal Cognitive Assessment score =24 4. Dementia, Mini Mental Status Examination score <24 5. Depression, Patient Health Questionnaire 9 score =12 6. Apparent neurological diseases and/or other severe psychiatric diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 14/12/2020: Cognition measured by the Montreal Cognitive Assessment (MoCA) at baseline and after 6 months _____ Previous primary outcome measure as of 23/06/2020: Cognition measured by the Montreal Cognitive Assessment (MoCA) at baseline and after 6 and 12 months _____ Previous primary outcome measure: Cognition measured by the Montreal Cognitive Assessment (MoCA) and Syndrom-Kurz-Test (SKT) at baseline and after 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 14/12/2020: 1. Cognition measured by reaction time and logical thinking assessments delivered and collected by the digital software at baseline and after 1, 2, 3, 4, 5 and 6 months and by the Mini-Mental Status Examination (MMSE) at baseline and after 6 months Exploratory outcome measures: Long-term cognitive status assessed using the Montreal Cognitive Assessment (MoCA) and the Mini-Mental Status Examination (MMSE), yearly in the open phase _____ Previous secondary outcome measures as of 23/06/2020: 1. Cognition measured by reaction time and logical thinking assessments delivered and collected by the digital software at baseline and after 1, 2, 3, 4, 5 and 6 months, Mini-Mental Status Examination (MMSE) at baseline and after 6 months 2. Long term cognitive decline assessed using the Mini-Mental Status Examination (MMSE) to analyse the conversion to dementia up to 3 years _____ Previous secondary outcome measures as of 25/03/2020: 1. Cognition measured by reaction time and logical thinking assessments delivered and collected by the digital software at baseline and after 1, 2, 3, 4, 5 and 6 months, Mini-Mental Status Examination (MMSE) at baseline and after 6 months 2. Functional anatomical changes assessed by medical imaging techniques such as cMRT of the subgroup involved at baseline and 6 months 3. Long term cognitive decline assessed using the Mini-Mental Status Examination (MMSE) to analyze the conversion to dementia at 1, 2, 3, 4 and 5 years _____ Previous secondary outcome measures as of 18/03/2020: 1. Cognition measured by reaction time and logical thinking assessments delivered and collected by the digital software at baseline and after 1, 2, 3, 4, 5 and 6 months, Mini-Mental Status Examination (MMSE) at baseline and after 6 months 2. Non-cognitive symptoms measured by a self-created instrument based on the Neuropsychiatric Inventory and the Mild Behavioral Impairment Checklist 3. Functional anatomical changes | — |
Countries
Germany