Condition category
Mental and Behavioural Disorders
Date applied
31/01/2020
Date assigned
27/02/2020
Last edited
23/06/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
With increasing life expectancy, the number of older people suffering from cognitive impairments increases. Mild cognitive impairment (MCI) often results in dementia (about 15% of people with MCI will eventually have dementia). Currently, there is no pharmacological therapy in primary prevention of dementia. Studies show that everyday motor or cognitive activations can reduce the risk of dementia to a limited extent.

The primary aim is to prove that compared with the standard digital training the MCI specialized digital training will lead to better results in cognitive abilities. The secondary aim is to improve or at least stabilize cognitive performance for a relevant period with a specialized digital cognition training. With this training we attempt to “noticeably” delay the rate of people who shift from MCI to dementia and thus we try to reduce the conversion rate.

Who can participate?
We focus on community-dwelling people with MCI who use a PC, laptop or tablet.

What does the study involve?
The goal is to develop a digital cognitive training that can be used from home with a computer, laptop or tablet. We compare two digital trainings: MCI specialized digital cognitive training and standard cognitive digital training. Participants are randomly allocated to one of these two groups.

What are the possible benefits and risks of participating?
The digital cognitive training might have an impact on existing excessive computer use. However, the cognitive training that we developed is not oriented on motivational or emotional components. The digital training requires cognitive performance which will rather lead to exhaustion.

With the digital cognitive training, we expect to stabilize cognitive performance. In the long run, we expect that it will help older adults with MCI to remain independent. Also, we expect to delay the rate of people who shift from MCI to dementia. Additionally, we expect positive effects on other non-cognitive aspects and quality of life.

Where is the study run from?
The Center for Health Services Research, University Hospital Erlangen (Germany)

When is the study starting and how long is it expected to run for?
March 2019 to March 2021, with open-ended, yearly follow up until March 2025

Who is funding the study?
Reinhard Frank-Stiftung (Germany)

Who is the main contact?
Prof. Elmar Graessel
elmar.graessel@uk-erlangen.de

Trial website

Contact information

Type

Scientific

Primary contact

Prof Elmar Graessel

ORCID ID

Contact details

Center for Health Services Research
Schwabachanlage 6
91052 Erlangen
Germany
Erlangen
91054
Germany
+49 91318534142
elmar.graessel@uk-erlangen.de

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Individualised computerised cognitive training for community-dwelling people with mild cognitive impairment

Acronym

Study hypothesis

Current study hypothesis as of 23/06/2020:
Primary hypothesis: Individualised CCT will lead to statistically significantly greater improvements in cognitive capacities over time in people with MCI as compared with basic CCT.
Secondary hypothesis: With individualised CCT, the rate at which people progress from MCI to dementia will be slowed.
_____
Previous study hypothesis:
Compared with the standard cognitive digital training the MCI specialized digital training will lead to better results in cognitive abilities.

Ethics approval

Approved 06/03/2020, Friedrich-Alexander-University Erlangen-Nürnberg Ethics Committee (Krankenhausstraße 12, 91054 Erlangen; +49 9131 85-22270; ethikkommission@fau.de), ref: 58-20 B.

Study design

Prospective double-blind randomized controlled intervention study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Prevention

Patient information sheet

See additional files (in German)

Condition

Mild cognitive impairment (MCI)

Intervention

Current interventions as of 23/06/2020:
The goal is to develop a specialized digital cognitive training for persons with MCI that can be used from home with a computer, laptop or tablet. Study participants can use the digital intervention as often as they wish over the duration of the trial (6 months).

Participants are randomly allocated into one of two groups:
1. Intervention group: Individualised computerised cognitive training, which involves targeted exercises for memory span, information processing, visual-spatial cognition, etc.
2. Control group: basic computerised cognitive training, which involves basic exercises for memory span, information processing, visual-spatial cognition, etc.

An external department will create randomization lists (Institute of Medical Informatics, Biometry, and Epidemiology, Friedrich-Alexander University Erlangen-Nürnberg, Waldstraße 6, 91054 Erlangen)
_____
Previous interventions:
The goal is to develop a specialized digital cognitive training for persons with MCI that can be used from home with a computer, laptop or tablet. Study participants can use the digital intervention as often as they wish over the duration of the trial (6 months).

Participants are randomly allocated into one of two groups:
1. MCI specialized cognitive training, which involves targeted exercises for memory span, information processing, visual-spatial cognition, and etc.
2. standard cognitive training, which involves basic exercises for memory span, information processing, visual-spatial cognition, and etc.

An external department will create randomization lists (Institute of Medical Informatics, Biometry, and Epidemiology, Friedrich-Alexander University Erlangen-Nürnberg, Waldstraße 6, 91054 Erlangen)

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Current 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 outcome measures

Current 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 assessed by medical imaging techniques such as cMRT of the subgroup involved at baseline and 6 months
4. 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:
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

Overall trial start date

01/04/2019

Overall trial end date

31/03/2025

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 23/06/2020:
1. Mild cognitive impairment
1.1. Montreal Cognitive Assessment score <24
1.2. Mini Mental State Examination score ≥ 24
2. Own computer/laptop/tablet and basic skills in their use
3. Age ≥ 60
4. Informed consent given
_____
Previous inclusion criteria:
1. Mild cognitive impairment
1.1. Montreal Cognitive Assessment score <24
1.2. Mini Mental State Examination score ≥ 24
2. Own computer/laptop/tablet and basic skills in their use
3. Age > 55
4. Informed consent given

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

100

Participant 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

Recruitment start date

09/06/2020

Recruitment end date

30/09/2020

Locations

Countries of recruitment

Germany

Trial participating centre

University Hospital Erlangen
Department of Psychiatry and Psychotherapy Center for Health Services Research in Medicine Friedrich-Alexander-University Erlangen-Nürnberg Schwabachanlage 10
Erlangen
91054
Germany

Sponsor information

Organisation

Reinhard Frank-Stiftung

Sponsor details

Mönckebergstr. 11
Hamburg
20095
Germany
+49 (0)402716960
info@reinhardfrank-stiftung.org

Sponsor type

Charity

Website

https://www.reinhardfrank-stiftung.org/

Funders

Funder type

Charity

Funder name

Reinhard Frank-Stiftung

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD Sharing statement:
The datasets generated during and/or analyzed during the current study are not expected to be made available because we assure in the participant information sheet that data will not be passed to any third party

Intention to publish date

31/12/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Editorial Notes

23/06/2020: The following changes were made to the trial record: 1. The recruitment resumed. 2. The recruitment start date was changed from 16/03/2020 to 09/06/2020. 3. The public title was changed from "Dementia prevention for older people suffering from mild cognitive impairment using digital brain training tools" to "Dementia prevention for older people suffering from mild cognitive impairment using computerised cognitive training tools". 4. The scientific title was changed from "Targeted digital cognitive training for community-dwelling persons with mild cognitve impairment (MCI)" to "Individualised computerised cognitive training for community-dwelling people with mild cognitive impairment". 5. The study hypothesis was changed. 6. The interventions were changed. 7. The primary outcome measure was changed. 8. The secondary outcome measures were changed. 9. The inclusion criteria were changed. 10. The participant information sheet latest version was uploaded. 25/03/2020: The following changes were made to the trial record: 1. The secondary outcome measures were changed. 2. Due to current public health guidance, recruitment for this study has been paused. 18/03/2020: The following changes were made to the trial record: 1. The ethics approval was added. 2. The updated participant information sheet was uploaded (V2) 3. The secondary outcome measures were changed. 27/02/2020: The participant information sheet has been uploaded. 07/02/2020: Trial’s existence confirmed by Reinhard Frank-Stiftung.