Alzheimer DiseaseNCT04452864
Tablet-based Cognitive Training
A study testing Computerized Cognitive Training and Documentaries with delayed Computerized Cognitive Training in people with Alzheimer Disease and Dementia, run by University of Bern at 2 sites in Switzerland.
Trial summary
Today the therapy options for dementia due to Alzheimer's disease (AD) are limited. One recommended intervention is cognitive stimulation. We try to develop serious games as a further treatment option, also usable in pre-dementia as well as early stages of dementia and for a long period of time. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Dementia, Mild Cognitive Impairment
- What is being tested?
- Computerized Cognitive Training and Documentaries with delayed Computerized Cognitive Training
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 1 Jul 2020to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Alzheimer's Disease
- Patients with increased risk for developing dementia
- Must be able to give their consent
Who cannot join
- Contra-indications for MRI scanning
- Substance abuse
- Severe medical conditions
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
University Hospital of Old Age Psychiatry and Psychotherapy
Bern, 3000
Memory Clinic Zentralschweiz
Lucerne, 6000
About this study
Official title: Can a Serious Game-based Cognitive Training Attenuate Cognitive Decline Related to Alzheimer's Disease
Today the therapy options for dementia due to Alzheimer's disease (AD) are limited. One recommended intervention is cognitive stimulation. We try to develop serious games as a further treatment option, also usable in pre-dementia as well as early stages of dementia and for a long period of time.
The main objective of this study is to test, if the computerized-cognitive training (CCT) is able to improve the performance in a score quantifying an "AD-specific" component score. Additionally, the neurobiological effects of the training are investigated.
Read the detailed description
The study intervention consists of a computer-based cognitive training, targeting the cognitive domains mostly affected by AD. This training will be performed for three months (each day for 20 minutes). After three months the intervention group will continue the training at home for six months and meet monthly for group sessions (i.e. booster sessions) on site.
Primary endpoint will be the change in an "AD-specific" component score, quantified by episodic memory, semantic memory and visuospatial abilities. Secondary endpoints are changes in task related brain networks and changes in resting state networks.
- Conditions
- Alzheimer Disease, Dementia, Mild Cognitive Impairment
- Being tested
- Computerized Cognitive Training, Documentaries with delayed Computerized Cognitive Training
- Keywords
- Alzheimer Disease, Dementia, Mild Cognitive Impairment, Cognitive Training, Serious Games
- Medical subject headings
- Alzheimer Disease, Dementia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Cognitive TrainingDevice
The study intervention consists of a tablet-based cognitive training, targeting the cognitive domains mostly affected by Alzheimer Disease.
Documentaries with delayed Computerized Cognitive TrainingDevice
The active control group watches documentaries for three months before starting with the CCT.
| Study group | Role | What they receive |
|---|---|---|
| Study Intervention | Experimental | The study intervention consists of a tablet-based cognitive training, targeting the cognitive domains mostly affected by AD. This training will be performed for three months (each day for 20 minutes). After three months this group will continue the training at home for six months and meet monthly for group sessions (i.e. booster sessions) on site. Receives: Device: Computerized Cognitive Training |
| Active Control Group | Active comparator | This control study arm will watch documentaries at home for three months (each day for 20 minutes) , instead of performing the CCT and serve as active control group. This group will also train with the CCT tasks after these three months. Receives: Device: Documentaries with delayed Computerized Cognitive Training |
| Wait-List Control | Other | This control study arm will start with the CCT with a delay of three months and serve as wait-list control group. Receives: Device: Computerized Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in AD specific component score
The outcome is quantified by an AD component score including measures of EM (auditory verbal learning), SM (verbal fluency, naming task) and spatial abilities (Rey-Osterrieth complex figure test). These scores will be assessed four times, before the training as well as after three, six and nine months by tablet-based cognitive tests. A short follow-up assessment will be performed after a total of 12 months which does not include primary outcome measure.
Measured: The primary endpoint will be assessed four times, with breaks of three months in between. Primary outcome will be assessed up to 9 months.
Secondary outcomes (1)
MRI functional and structural
Secondary endpoints are changes in task related brain networks (i.e. spatial ability and episodic memory) and changes in resting state networks.
Measured: Secondary endpoints will be assessed two to four times, depending on the study arm, as MRI assessments are not always performed after six and nine months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start1 Jul 2020
- Primary completion9 Jul 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of three study arms and conduct a Computerized Cognitive Training (CCT) at home (daily) and on site (weekly) for 10 weeks. Before and after the CCT, neuropsychological assessments will be conducted.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Klöppel, Prof. Dr., Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452864
- Sponsor's protocol ID
- 2020-00630
- Status last verified
- Jan 2025
- First submitted
- 24 Jun 2020
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be published pseudonymized in a open access data base
Publications
Brill E, Krebs C, Falkner M, Peter J, Henke K, Zust M, Minkova L, Brem AK, Kloppel S. Can a serious game-based cognitive training attenuate cognitive decline related to Alzheimer's disease? Protocol for a randomized controlled trial. BMC Psychiatry. 2022 Aug 12;22(1):552. doi: 10.1186/s12888-022-04131-7.
PubMed 35962371
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can a Serious Game-based Cognitive Training Attenuate Cognitive Decline Related to Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT04452864
- Acronym / sponsor ID
- 2020-00630
- Conditions
- Alzheimer Disease, Dementia, Mild Cognitive Impairment
- Keywords
- Alzheimer Disease, Dementia, Mild Cognitive Impairment, Cognitive Training, Serious Games
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 9 Jul 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 1 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Today the therapy options for dementia due to Alzheimer's disease (AD) are limited. One recommended intervention is cognitive stimulation. We try to develop serious games as a further treatment option, also usable in pre-dementia as well as early stages of dementia and for a long period of time.
The main objective of this study is to test, if the computerized-cognitive training (CCT) is able to improve the performance in a score quantifying an "AD-specific" component score. Additionally, the neurobiological effects of the training are investigated.
Detailed description
The study intervention consists of a computer-based cognitive training, targeting the cognitive domains mostly affected by AD. This training will be performed for three months (each day for 20 minutes). After three months the intervention group will continue the training at home for six months and meet monthly for group sessions (i.e. booster sessions) on site.
Primary endpoint will be the change in an "AD-specific" component score, quantified by episodic memory, semantic memory and visuospatial abilities. Secondary endpoints are changes in task related brain networks and changes in resting state networks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three study arms and conduct a Computerized Cognitive Training (CCT) at home (daily) and on site (weekly) for 10 weeks. Before and after the CCT, neuropsychological assessments will be conducted.
| Arm | Type | Receives |
|---|---|---|
| Study Intervention | Experimental | Device: Computerized Cognitive TrainingThe study intervention consists of a tablet-based cognitive training, targeting the cognitive domains mostly affected by AD. This training will be performed for three months (each day for 20 minutes). After three months this group will continue the training at home for six months and meet monthly for group sessions (i.e. booster sessions) on site. |
| Active Control Group | Active comparator | Device: Documentaries with delayed Computerized Cognitive TrainingThis control study arm will watch documentaries at home for three months (each day for 20 minutes) , instead of performing the CCT and serve as active control group. This group will also train with the CCT tasks after these three months. |
| Wait-List Control | Other | Device: Computerized Cognitive TrainingThis control study arm will start with the CCT with a delay of three months and serve as wait-list control group. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of Alzheimer's Disease
- Patients with increased risk for developing dementia
- Must be able to give their consent
Key exclusion criteria (3 listed)
- Contra-indications for MRI scanning
- Substance abuse
- Severe medical conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized Cognitive TrainingThe study intervention consists of a tablet-based cognitive training, targeting the cognitive domains mostly affected by Alzheimer Disease. | Device | Study Intervention, Wait-List Control |
| Documentaries with delayed Computerized Cognitive TrainingThe active control group watches documentaries for three months before starting with the CCT. | Device | Active Control Group |
Primary outcome
Change in AD specific component score
Time frame: The primary endpoint will be assessed four times, with breaks of three months in between. Primary outcome will be assessed up to 9 months.
The outcome is quantified by an AD component score including measures of EM (auditory verbal learning), SM (verbal fluency, naming task) and spatial abilities (Rey-Osterrieth complex figure test). These scores will be assessed four times, before the training as well as after three, six and nine months by tablet-based cognitive tests. A short follow-up assessment will be performed after a total of 12 months which does not include primary outcome measure.
1 secondary outcome
MRI functional and structural
Time frame: Secondary endpoints will be assessed two to four times, depending on the study arm, as MRI assessments are not always performed after six and nine months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Background: PubMed 35962371Brill E, Krebs C, Falkner M, Peter J, Henke K, Zust M, Minkova L, Brem AK, Kloppel S. Can a serious game-based cognitive training attenuate cognitive decline related to Alzheimer's disease? Protocol for a randomized controlled trial. BMC Psychiatry. 2022 Aug 12;22(1):552. doi: 10.1186/s12888-022-04131-7.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be published pseudonymized in a open access data base
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Klöppel, Prof. Dr. principal investigator
University of Bern
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Cognitive Training and Documentaries with delayed Computerized Cognitive Training in people with Alzheimer Disease and Dementia, run by University of Bern at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in AD specific component score (time frame: The primary endpoint will be assessed four times, with breaks of three months in between. Primary outcome will be assessed up to 9 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04452864, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.