Mild Cognitive ImpairmentNCT06399978
The Feasibility and Effect of Digital Cognitive Training in Mild Cognitive Impairment
A study testing Brain Blossom - Gamified Differential Outcome Training and Gamified Non-Differential Outcome Training in people with Mild Cognitive Impairment, run by Pernille Louise Kjeldsen at 1 site in Denmark.
Trial summary
The goal of this study is to assess the feasibility and effect of digital cognitive training based on the principles of Differential Outcome Training (DOT) in patients with Mild Cognitive Impairment. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Brain Blossom - Gamified Differential Outcome Training and Gamified Non-Differential Outcome Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 6 May 2024to 31 Jan 2025
- 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 65 to 80 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age: 65-80
- MCI diagnosis made by a specialist in a Dementia Clinic:
- Meeting the diagnostic criteria for a diagnosis of MCI
- Abnormal memory function compared to age and education as assessed with a neuropsychological assessment prior to enrolment in the study
- Generally preserved Activities of Daily Living (ADL)
- Not demented
- MCI diagnosis should be made no more than 6 months before enrolment in the study
Who cannot join
- Significant systemic disease or unstable medical or psychiatric disorder
- Past history of stroke, brain damage, head trauma, or concussion, which significantly affects level of functioning
- Past history of significant alcohol or drug abuse
- Significantly impaired vision or hearing
- Colour blindness
- Danish as a second language
- Participation in any other clinical studies during project participation
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of Neurology, Aalborg University Hospital
Aalborg, North Denmark, 9000
Jakob U Blicher, Professor, j.blicher@rn.dk
About this study
Official title: The Feasibility and Effect of Cognitive Training on Objective and Subjective Cognitive Functioning in Patients With Mild Cognitive Impairment: A Pilot Study
The goal of this study is to assess the feasibility and effect of digital cognitive training based on the principles of Differential Outcome Training (DOT) in patients with Mild Cognitive Impairment. In DOT training, each stimulus-response pair to be learnt is followed by a unique reinforcer, as opposed to non-DOT (NDOT) training, where the stimulus-response pairs are all followed by a random reinforcer. DOT training is believed to boost learning more than NDOT training through associations.
The main questions the study aims to answer are:
Read more
- Whether at-home, tablet-based digital cognitive training is feasible in elderly patients with Mild Cognitive Impairment
- Whether regularly digital cognitive DOT training has a positive effect on patients' cognitive functioning and quality of life
- Whether any potential effects that the cognitive DOT training may have on the patients' cognitive functioning are transferable to the patients' daily life.
Participation in the study includes:
- A pre-training session at the site with the primary project coordinator, where the patient will complete a number of self-report questionnaires about their health, cognition, and quality of life as well as a neuropsychological assessment.
- Training with the digital cognitive DOT training program at home for 20 min. per day 3-4 times a week for 6-8 weeks.
- A post-training session at the site with the primary project coordinator after the 6-8 weeks have passed, where the patient will complete a usability questionnaire about the training programme, some of the same self-report questionnaires about their health, cognition, and quality of life as well as some of the neuropsychological assessments.
- A 1-month follow-up session where the patients will complete some of the same self-report questionnaires again about their cognition and quality of life plus a questionnaire aimed the transferability of any positive cognitive effects of the training.
Read the detailed description
Alzheimer's disease (AD) is the most common form of dementia, a debilitating neurodegenerative disease with cognitive impairments, especially impairments in memory, at its core. AD is progressive, with cognitive symptoms gradually worsening as AD brain pathology builds over time. The clinical construct of Mild Cognitive Impairment (MCI) represents an intermediate stage between healthy ageing and early dementia with cognitive impairment that is worse than what is seen in healthy ageing, but not enough to interfere with daily living. Although, not all MCI cases lead to dementia, the majority of cases eventually progress.
The amnestic subtype of MCI, which is especially characterised by the presence of memory impairments, is the most likely to progress to AD dementia. In line with the evolution of brain neurodegeneration in AD, typically beginning in memory-related medial-temporal limbic areas, which specifically contribute to forming and accessing spatial contextual short-term memories, spatial memory deficits are especially common in amnestic MCI. AD patients and even amnestic MCI patients perform worse on visuospatial short-term memory tasks compared to healthy participants and individuals with other neurodegenerative disorders. Memory functions are essential for daily living, and memory impairments have been shown to be a major determinant of health outcomes and well-being in age-related disorders.
At the time an MCI diagnosis is made, the pathological burden is often so high that it is almost impossible to stop or reverse the cognitive impairment. Presently, there is no cure for AD or any other type of dementia, and available pharmacological treatments have only very limited effects on cognitive symptoms. A major research priority should therefore be to develop non-pharmacological approaches, which are cost-effective and potentially feasible for large-scale implementation, to preserve and promote cognitive function and improve quality of life early on in MCI.
Previous studies have shown beneficial effects of cognitive training in MCI and AD patients using a novel training procedure that has been proposed to active and relay on memory processes and brain structures that are less affected in MCI and AD - The Differential Outcome Training (DOT). DOT training is based on the principle that each stimulus-response association to be learned is followed by a unique reinforcer, relative to a condition where reinforcers are presented randomly (non-differential outcomes training, NDOT). DOT training has been shown to result in enhanced learning, including faster acquisition, better overall retention, and higher retention accuracy, in both animals and humans. Nonetheless, the effects of a prolonged DOT training on visuospatial short-term memory performance and possible transfer of any benefits to other memory tasks and cognitive domains as well as its impact on quality of life in patients with MCI requires further research.
This study aims to establish the feasibility and effectiveness of a recently developed digital, gamified type of cognitive training in individuals with MCI. The study aims to address this by using a recently developed gamified version of the DOT task. This gamified DOT task integrates the DOT procedure within a gardening task. Participants are introduced to a botanic garden that they have to keep up, which includes cleaning up, obtaining seeds, planting plants, and putting up decorations. They can obtain seeds, plants, and money by performing a visuospatial short-term memory DOT task, which they can then use for the garden.
The purpose of this study is threefold: 1) to assess if digital, gamified cognitive training at home is feasible in elderly patients with MCI, 2) to explore the effectiveness of the gamified version of the DOT task on MCI patients' cognitive functioning and quality of life, and 3) to explore any possible transfer benefits of the DOT training to other cognitive tasks and to individuals' self-report measures of quality of life.
For this study, 40 MCI patients aged 65-80 will be recruited from the local Dementia Clinic. The patients will be randomly assigned to an intervention group (gamified DOT group, N=20) and an active control group (gamified NDOT, N=20). The patients will meet with the project coordinator for a pre-training session to assess their cognitive functioning and wellbeing prior to the cognitive training, after which they will complete 6-8 weeks of training at home, and will upon completion of the training come back in for a post-training session to assess whether the patients found the cognitive training feasible and whether the training has had an effect on the patients' cognitive functioning and wellbeing.
The study follows the Helsinki Declaration and will not begin before the necessary ethical and other approvals have been obtained. Laws and guidelines regarding handling personal data (GDPR rules) will also be followed with regards to all parts of the study.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Brain Blossom - Gamified Differential Outcome Training, Gamified Non-Differential Outcome Training
- Keywords
- Mild cognitive impairment, Alzheimer's disease, Cognitive functioning, Quality of life, Digital cognitive training, Gamified cognitive training
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Blossom - Gamified Differential Outcome TrainingBehavioural
Also called DOT
Digital cognitive training with a gamified DOT task for 20 minutes per day 3-4 times a week for 6-8 weeks.
Gamified Non-Differential Outcome TrainingBehavioural
Also called NDOT
Digital cognitive training with a gamified NDOT task for 20 minutes per day 3-4 times a week for 6-8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Gamified DOT | Experimental | Participants perform digital cognitive training with a program based on the Differential Outcomes Training (DOT) principle, in which each stimulus-response association to be learnt is followed by a unique reinforcer/outcome, in order to boost associative learning. Receives: Behavioral: Brain Blossom - Gamified Differential Outcome Training |
| Gamified non-DOT | Active comparator | Participants perform digital cognitive training with a non-Differential Outcomes Training (NDOT) programme, in which each stimulus-response association to be learnt is followed by a random reinforcer/outcome. Receives: Behavioral: Gamified Non-Differential Outcome Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of the digital cognitive training program assessed with a self-report questionnaire
Participants are asked to fill out a self-report questionnaire made specifically for this study. The questionnaire includes 10 questions about the participants' experience with the digital cognitive training post-training, including whether the programme ran smoothly, was easy to use, was engaging, and was fun, and whether the participants would be interested in playing it or similar game again in the future.
Measured: Post-training (6-8 weeks)
Memory task performance assessed with a Differential Outcome Task (DOT task)
Participants are asked to complete a computerised face recognition DOT task. Participants are presented with different faces and asked which ones they have seen previously. The responses are each followed by an outcome. There are two versions of the task: a DOT version where each correctly identified face is associated with a certain outcome, and a NDOT version, in which the outcomes appear randomly.
Measured: Post-training (6-8 weeks)
Visuo-spatial memory task performance assessed with a gamified visuo-spatial memory task (Starry Night)
Participants are asked to complete the 20-min gamified visuo-spatial memory task, Starry Night. Participants are presented with complex patterns somewhere on a screen for a few seconds at a time. After a short pause, different complex patterns appear on the screen, of which one was the pattern the participant just saw. The participant needs to both choose the correct pattern and then place it on the spot on the screen where it previously appeared.
Measured: Post-training (6-8 weeks)
Subjective cognitive functioning assessed by the 20-Item Short-Form Change in Cognition Scale (CCI-S-20)
Participants are asked to fill out the 20-Item Short-Form Change in Cognition Scale (CCI-S-20). This version of the questionnaire contains 20 questions about memory functions in daily life. Participants indicate on a 5-point rating scale if they think their own memory functions are the same as they have always been or if they have become worse, and if so, to which degree. Participants' ratings can be between 0 ('no change in that memory function') to 4 ('severe change in that memory function'). A higher score indicates worse cognition.
Measured: Post-training (6-8 weeks)
Quality of life assessed with the Quality of Life Ladder (QoL Ladder)
The Quality of Life Ladder is a commonly used, simple task. Participants are asked to rate their quality of life on a scale from 1 to 8, where 1 is the worst and 8 is the best possible quality of life they could realistically have.
Measured: Post-training (6-8 weeks)
Depressive symptoms assessed with the 15-Item Geriatric Depression Scale (GDS-15)
Participants are asked to fill out the 15-Item Geriatric Depression scale (GDS-15). The GDS is a very commonly used measure for depressive symptoms in elderly individuals. The participants are presented with 15 yes- or no-questions. Their responses for each question are coded as either 0 or 1, where 0 indicates that depressive symptoms are not present, while a score of 1 indicates the presence of a depressive symptom. Participants can score between 0 and 15, where a higher score indicates worse mood. A cut-off score of 5 is used, insofar that participants with a score more than five likely have depression.
Measured: Post-training (6-8 weeks)
Secondary outcomes (3)
Longterm visuo-spatial memory performance assessed with Starry Night
Participants are asked to complete the 20-min gamified visuo-spatial memory task, Starry Night, in which they need to remember the shape and location of different, complex patterns.
Measured: 1-month follow-up
Quality of life assessed with the QoL Ladder
Participants are asked to rate their quality of life on a scale from 1 to 8, where 1 is the worst and 8 is the best possible quality of life they could realistically have.
Measured: 1-month follow-up
Depressive symptoms assessed with the GDS-15
Participants are asked to fill out the GDS-15.
Measured: 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start6 May 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies 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
- In this study, 40 MCI participants will be randomly assigned to either an intervention group (digital cognitive training with a gamified DOT programme, N=20) or an active control group (digital cognitive training with a gamified non-DOT programme, N=20).
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pernille Louise Kjeldsen
- Sponsor type
- University, hospital or other
- Collaborators
- Brain+ ApS, Eurostars EUREKA, Innovation Fund Denmark, University of Aarhus
- Responsible party
- Sponsor-investigator, Pernille Louise Kjeldsen, Aalborg University Hospital
- Investigators
- Jakob U Blicher, Professor, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06399978
- Sponsor's protocol ID
- ACTTDCS
- Status last verified
- May 2024
- First submitted
- 20 Mar 2024
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Effect of Cognitive Training on Objective and Subjective Cognitive Functioning in Patients With Mild Cognitive Impairment: A Pilot Study
- ClinicalTrials.gov ID
- NCT06399978
- Acronym / sponsor ID
- ACTTDCS
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild cognitive impairment, Alzheimer's disease, Cognitive functioning, Quality of life, Digital cognitive training, Gamified cognitive training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Pernille Louise KjeldsenUniversity, hospital or other
- Collaborators
- Brain+ ApS, Eurostars EUREKA, Innovation Fund Denmark, University of Aarhus
- Study start
- 6 May 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 6 May 2024 (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.
The goal of this study is to assess the feasibility and effect of digital cognitive training based on the principles of Differential Outcome Training (DOT) in patients with Mild Cognitive Impairment. In DOT training, each stimulus-response pair to be learnt is followed by a unique reinforcer, as opposed to non-DOT (NDOT) training, where the stimulus-response pairs are all followed by a random reinforcer. DOT training is believed to boost learning more than NDOT training through associations.
The main questions the study aims to answer are:
- Whether at-home, tablet-based digital cognitive training is feasible in elderly patients with Mild Cognitive Impairment
- Whether regularly digital cognitive DOT training has a positive effect on patients' cognitive functioning and quality of life
- Whether any potential effects that the cognitive DOT training may have on the patients' cognitive functioning are transferable to the patients' daily life.
Participation in the study includes:
- A pre-training session at the site with the primary project coordinator, where the patient will complete a number of self-report questionnaires about their health, cognition, and quality of life as well as a neuropsychological assessment.
- Training with the digital cognitive DOT training program at home for 20 min. per day 3-4 times a week for 6-8 weeks.
- A post-training session at the site with the primary project coordinator after the 6-8 weeks have passed, where the patient will complete a usability questionnaire about the training programme, some of the same self-report questionnaires about their health, cognition, and quality of life as well as some of the neuropsychological assessments.
- A 1-month follow-up session where the patients will complete some of the same self-report questionnaires again about their cognition and quality of life plus a questionnaire aimed the transferability of any positive cognitive effects of the training.
Detailed description
Alzheimer's disease (AD) is the most common form of dementia, a debilitating neurodegenerative disease with cognitive impairments, especially impairments in memory, at its core. AD is progressive, with cognitive symptoms gradually worsening as AD brain pathology builds over time. The clinical construct of Mild Cognitive Impairment (MCI) represents an intermediate stage between healthy ageing and early dementia with cognitive impairment that is worse than what is seen in healthy ageing, but not enough to interfere with daily living. Although, not all MCI cases lead to dementia, the majority of cases eventually progress.
The amnestic subtype of MCI, which is especially characterised by the presence of memory impairments, is the most likely to progress to AD dementia. In line with the evolution of brain neurodegeneration in AD, typically beginning in memory-related medial-temporal limbic areas, which specifically contribute to forming and accessing spatial contextual short-term memories, spatial memory deficits are especially common in amnestic MCI. AD patients and even amnestic MCI patients perform worse on visuospatial short-term memory tasks compared to healthy participants and individuals with other neurodegenerative disorders. Memory functions are essential for daily living, and memory impairments have been shown to be a major determinant of health outcomes and well-being in age-related disorders.
At the time an MCI diagnosis is made, the pathological burden is often so high that it is almost impossible to stop or reverse the cognitive impairment. Presently, there is no cure for AD or any other type of dementia, and available pharmacological treatments have only very limited effects on cognitive symptoms. A major research priority should therefore be to develop non-pharmacological approaches, which are cost-effective and potentially feasible for large-scale implementation, to preserve and promote cognitive function and improve quality of life early on in MCI.
Previous studies have shown beneficial effects of cognitive training in MCI and AD patients using a novel training procedure that has been proposed to active and relay on memory processes and brain structures that are less affected in MCI and AD - The Differential Outcome Training (DOT). DOT training is based on the principle that each stimulus-response association to be learned is followed by a unique reinforcer, relative to a condition where reinforcers are presented randomly (non-differential outcomes training, NDOT). DOT training has been shown to result in enhanced learning, including faster acquisition, better overall retention, and higher retention accuracy, in both animals and humans. Nonetheless, the effects of a prolonged DOT training on visuospatial short-term memory performance and possible transfer of any benefits to other memory tasks and cognitive domains as well as its impact on quality of life in patients with MCI requires further research.
This study aims to establish the feasibility and effectiveness of a recently developed digital, gamified type of cognitive training in individuals with MCI. The study aims to address this by using a recently developed gamified version of the DOT task. This gamified DOT task integrates the DOT procedure within a gardening task. Participants are introduced to a botanic garden that they have to keep up, which includes cleaning up, obtaining seeds, planting plants, and putting up decorations. They can obtain seeds, plants, and money by performing a visuospatial short-term memory DOT task, which they can then use for the garden.
The purpose of this study is threefold: 1) to assess if digital, gamified cognitive training at home is feasible in elderly patients with MCI, 2) to explore the effectiveness of the gamified version of the DOT task on MCI patients' cognitive functioning and quality of life, and 3) to explore any possible transfer benefits of the DOT training to other cognitive tasks and to individuals' self-report measures of quality of life.
For this study, 40 MCI patients aged 65-80 will be recruited from the local Dementia Clinic. The patients will be randomly assigned to an intervention group (gamified DOT group, N=20) and an active control group (gamified NDOT, N=20). The patients will meet with the project coordinator for a pre-training session to assess their cognitive functioning and wellbeing prior to the cognitive training, after which they will complete 6-8 weeks of training at home, and will upon completion of the training come back in for a post-training session to assess whether the patients found the cognitive training feasible and whether the training has had an effect on the patients' cognitive functioning and wellbeing.
The study follows the Helsinki Declaration and will not begin before the necessary ethical and other approvals have been obtained. Laws and guidelines regarding handling personal data (GDPR rules) will also be followed with regards to all parts of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- In this study, 40 MCI participants will be randomly assigned to either an intervention group (digital cognitive training with a gamified DOT programme, N=20) or an active control group (digital cognitive training with a gamified non-DOT programme, N=20).
| Arm | Type | Receives |
|---|---|---|
| Gamified DOT | Experimental | Behavioral: Brain Blossom - Gamified Differential Outcome TrainingParticipants perform digital cognitive training with a program based on the Differential Outcomes Training (DOT) principle, in which each stimulus-response association to be learnt is followed by a unique reinforcer/outcome, in order to boost associative learning. |
| Gamified non-DOT | Active comparator | Behavioral: Gamified Non-Differential Outcome TrainingParticipants perform digital cognitive training with a non-Differential Outcomes Training (NDOT) programme, in which each stimulus-response association to be learnt is followed by a random reinforcer/outcome. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Age: 65-80
- MCI diagnosis made by a specialist in a Dementia Clinic:
- MCI diagnosis should be made no more than 6 months before enrolment in the study
Key exclusion criteria (7 listed)
- Significant systemic disease or unstable medical or psychiatric disorder
- Past history of stroke, brain damage, head trauma, or concussion, which significantly affects level of functioning
- Past history of significant alcohol or drug abuse
- Significantly impaired vision or hearing
- Colour blindness
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 |
|---|---|---|
| Brain Blossom - Gamified Differential Outcome TrainingAlso: DOTDigital cognitive training with a gamified DOT task for 20 minutes per day 3-4 times a week for 6-8 weeks. | Behavioural | Gamified DOT |
| Gamified Non-Differential Outcome TrainingAlso: NDOTDigital cognitive training with a gamified NDOT task for 20 minutes per day 3-4 times a week for 6-8 weeks. | Behavioural | Gamified non-DOT |
Primary outcome
Usability of the digital cognitive training program assessed with a self-report questionnaire
Time frame: Post-training (6-8 weeks)
Participants are asked to fill out a self-report questionnaire made specifically for this study. The questionnaire includes 10 questions about the participants' experience with the digital cognitive training post-training, including whether the programme ran smoothly, was easy to use, was engaging, and was fun, and whether the participants would be interested in playing it or similar game again in the future.
Memory task performance assessed with a Differential Outcome Task (DOT task)
Time frame: Post-training (6-8 weeks)
Participants are asked to complete a computerised face recognition DOT task. Participants are presented with different faces and asked which ones they have seen previously. The responses are each followed by an outcome. There are two versions of the task: a DOT version where each correctly identified face is associated with a certain outcome, and a NDOT version, in which the outcomes appear randomly.
Visuo-spatial memory task performance assessed with a gamified visuo-spatial memory task (Starry Night)
Time frame: Post-training (6-8 weeks)
Participants are asked to complete the 20-min gamified visuo-spatial memory task, Starry Night. Participants are presented with complex patterns somewhere on a screen for a few seconds at a time. After a short pause, different complex patterns appear on the screen, of which one was the pattern the participant just saw. The participant needs to both choose the correct pattern and then place it on the spot on the screen where it previously appeared.
Subjective cognitive functioning assessed by the 20-Item Short-Form Change in Cognition Scale (CCI-S-20)
Time frame: Post-training (6-8 weeks)
Participants are asked to fill out the 20-Item Short-Form Change in Cognition Scale (CCI-S-20). This version of the questionnaire contains 20 questions about memory functions in daily life. Participants indicate on a 5-point rating scale if they think their own memory functions are the same as they have always been or if they have become worse, and if so, to which degree. Participants' ratings can be between 0 ('no change in that memory function') to 4 ('severe change in that memory function'). A higher score indicates worse cognition.
Quality of life assessed with the Quality of Life Ladder (QoL Ladder)
Time frame: Post-training (6-8 weeks)
The Quality of Life Ladder is a commonly used, simple task. Participants are asked to rate their quality of life on a scale from 1 to 8, where 1 is the worst and 8 is the best possible quality of life they could realistically have.
Depressive symptoms assessed with the 15-Item Geriatric Depression Scale (GDS-15)
Time frame: Post-training (6-8 weeks)
Participants are asked to fill out the 15-Item Geriatric Depression scale (GDS-15). The GDS is a very commonly used measure for depressive symptoms in elderly individuals. The participants are presented with 15 yes- or no-questions. Their responses for each question are coded as either 0 or 1, where 0 indicates that depressive symptoms are not present, while a score of 1 indicates the presence of a depressive symptom. Participants can score between 0 and 15, where a higher score indicates worse mood. A cut-off score of 5 is used, insofar that participants with a score more than five likely have depression.
3 secondary outcomes
Longterm visuo-spatial memory performance assessed with Starry Night
Time frame: 1-month follow-up
Quality of life assessed with the QoL Ladder
Time frame: 1-month follow-up
Depressive symptoms assessed with the GDS-15
Time frame: 1-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Individual participant dataSharing planned: No
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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.
Jakob U Blicher, Professor principal investigator
Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain Blossom - Gamified Differential Outcome Training and Gamified Non-Differential Outcome Training in people with Mild Cognitive Impairment, run by Pernille Louise Kjeldsen at 1 site in Denmark.
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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pernille L Kjeldsen, MSc, PhD (004520648033, pernille.kjeldsen@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of the digital cognitive training program assessed with a self-report questionnaire (time frame: Post-training (6-8 weeks)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2024.