Dementia prevention for older people suffering from mild cognitive impairment using computerised cognitive training tools
| ISRCTN | ISRCTN14437015 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14437015 |
- Submission date
- 31/01/2020
- Registration date
- 27/02/2020
- Last edited
- 17/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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 July 2021, with open-ended, yearly follow up
Who is funding the study?
Reinhard Frank-Stiftung (Germany)
Who is the main contact?
Prof. Elmar Graessel
elmar.graessel@uk-erlangen.de
Contact information
Scientific
Center for Health Services Research
Schwabachanlage 6
91052 Erlangen
Germany
Erlangen
91054
Germany
| Phone | +49 91318534142 |
|---|---|
| elmar.graessel@uk-erlangen.de |
Study information
| Study design | Prospective double-blind randomized controlled intervention study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Prevention |
| Participant information sheet | ISRCTN14437015_PIS_German_V1_07Feb2020.pdf |
| Scientific title | Individualised computerised cognitive training for community-dwelling people with mild cognitive impairment |
| Study objectives | Current study hypothesis as of 14/12/2020: 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. Exploratory study question: In an open phase of the study we will investigate long-term cognitive status yearly. _____ Previous 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 outcome measures | 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 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 study start date | 01/04/2019 |
| Completion date | 31/03/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 89 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 09/06/2020 |
| Date of final enrolment | 31/01/2021 |
Locations
Countries of recruitment
- Germany
Study participating centre
Center for Health Services Research in Medicine
Friedrich-Alexander-University Erlangen-Nürnberg
Schwabachanlage 10
Erlangen
91054
Germany
Sponsor information
Charity
Mönckebergstr. 11
Hamburg
20095
Germany
| Phone | +49 (0)402716960 |
|---|---|
| info@reinhardfrank-stiftung.org | |
| Website | https://www.reinhardfrank-stiftung.org/ |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version V1 | 07/02/2020 | 27/02/2020 | No | Yes |
| Participant information sheet | version V2 | 10/03/2020 | 18/03/2020 | No | Yes |
| Protocol article | 05/05/2022 | 06/05/2022 | Yes | No | |
| Results article | 15/10/2024 | 17/10/2024 | Yes | No |
Additional files
- ISRCTN14437015_PIS_German_V1_07Feb2020.pdf
- Uploaded 27/02/2020
- ISRCTN14437015_PIS_German_V2_10Mar2020.pdf
- uploaded 18/03/2020
Editorial Notes
17/10/2024: Publication reference added.
06/05/2022: Publication reference added.
07/12/2021: The total final enrolment number was added and the intention to publish date was changed from 31/12/2021 to 31/12/2022.
14/12/2020: The following changes have been made:
1. The recruitment end date has been changed from 31/12/2020 to 31/01/2021.
2. The study hypothesis has been changed.
3. The primary outcome measure has been changed.
4. The secondary outcome measures have been changed.
5. The plain English summary has been updated to reflect the change in follow-up parameters.
25/09/2020: The recruitment end date has been changed from 30/09/2020 to 31/12/2020.
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.
