- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07521865
Remote Technologies in Early Stages of Alzheimer's Disease
Remote Technologies in Early Stages of Alzheimer's Disease: Feasibility, Usability, and Acceptance of an App-based Cognitive Training
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators aim to extend a tablet-computer-based cognitive training (CT), fully developed in house (KEK 2020-00630), and tailored specifically towards a "typical-AD" cognitive component. This cognitive component is defined through a principal-component analysis (PCA), on which the domains affected by AD (episodic memory, spatial processing, semantic memory) have high loadings. The investigators moreover train working memory training to facilitate transfer effects. By including carers (family members, friends, professional carers) in the focus groups and the integration of help buttons, the investigators expect high adherence. The CT will be based on our ongoing study assessing the CT in people at risk for AD and subjective cognitive decline.
The investigators plan a small feasibility study in three different groups with a total of 36 elderly participants including cognitively normal (N=12), MCI (N=12), and mild-moderate stage dementia due to AD (N=12).
The focus will be on qualitative content analyses based on the results from the focus groups. The results from the first focus group sessions serve the selection, adaptation, and improvement of the CT before it is implemented in the two-week intervention including daily 30-minutes training sessions. A second focus group after the intervention will serve to gain additional insights from users and carers to further improve the CT. To complement this information, the investigators will quantitatively compare specific game parameters related to feasibility (number of levels achieved, numbers of sessions finished, number of dropouts), usability (time until reaching level 1 - learn duration, numbers of help button presses), and acceptability (game evaluation) between the three treatment groups.
The investigators aim to demonstrate that remote CT is possible in older adults with Mild Cognitive Impairment (MCI) and diagnosed AD dementia at home and in the care home setting by extending an existing tablet-based CT app with additional (easier) training levels, additional and detailed introductory material to also allow cognitively more severely impaired participants to conduct the CT with as little external support as possible. This study is considered as Risk Category A. The study intervention consists of a tablet-based CT, which does not provide any known risks for the participants.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Bern, Switzerland, 3000
- University Hospital of Old Age Psychiatry and Psychotherapy Bern
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Participants and study partners fulfilling all the following inclusion criteria are eligible for the study:
• Informed Consent as documented by signature
Study partners:
• Native or fluent German speaker
Participants:
- Are able to give their consent to participate in the study
- Age between 70 and 95 years
- Native or fluent German speaker
- Normal or corrected to normal vision and hearing
- Ability to visit the study location repeatedly
- MoCA score > 11
Exclusion Criteria:
- Substance abuse
- Severe neurological or psychiatric conditions (of note: patients with mild depressive symptoms not fulfilling the criteria for major depressive disorder will be recruited into the sample to better represent clinical reality)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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HC - Healthy Control Group
Healthy, age- and sex-matched participants (cognitively normal)
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The cognitive training is administered remotely for 2 weeks daily (10 sessions).
The participants play all 12 games for 8 minutes in each session.
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MCI - Mild Cognitive Impairment
Participants with MCI
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The cognitive training is administered remotely for 2 weeks daily (10 sessions).
The participants play all 12 games for 8 minutes in each session.
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AD - Alzheimer's Disease
Participants with mild-moderate stage dementia due to AD
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The cognitive training is administered remotely for 2 weeks daily (10 sessions).
The participants play all 12 games for 8 minutes in each session.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Feasibility of tablet-based cognitive training
Time Frame: Assessed at the end of the 2-week intervention (Day 10)
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Compliance rate (i.e.number of sessions completed)
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Assessed at the end of the 2-week intervention (Day 10)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Feasibility of tablet-based cognitive training
Time Frame: Assessed at the end of the 2-week intervention (Day 10)
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Number of levels achieved
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Assessed at the end of the 2-week intervention (Day 10)
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Usability
Time Frame: Assessed at the end of the 2-week intervention (Day 10)
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Time until accomplishment of the first level (learning time)
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Assessed at the end of the 2-week intervention (Day 10)
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Acceptability
Time Frame: Assessed within two weeks after day 10 of the intervention
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Qualitative evaluation of the games in a semi-structured interview (Focus group discussion).
For each game, the same questions will be addressed in an open discussion.
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Assessed within two weeks after day 10 of the intervention
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2. Feasibility of tablet-based cognitive training
Time Frame: Assessed at the end of the 2-week intervention (Day 10)
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Number of drop-outs
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Assessed at the end of the 2-week intervention (Day 10)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Support 1
Time Frame: Assessed at the end of the 2-week intervention (Day 10)
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The extent of support needed from study partners (diary notes)
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Assessed at the end of the 2-week intervention (Day 10)
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Support 2
Time Frame: Assessed at the end of the 2-week intervention (Day 10)
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The number of sessions for which support was required (diary notes)
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Assessed at the end of the 2-week intervention (Day 10)
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Wellbeing
Time Frame: Assessed every day during the intervention, a couple of seconds before playing the games (answering the in-game question on the tablet precedes playing the scheduled session).
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Influence on mood and wellbeing (questionnaire)
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Assessed every day during the intervention, a couple of seconds before playing the games (answering the in-game question on the tablet precedes playing the scheduled session).
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Evaluation of Games by Study Partner
Time Frame: Assessed every day after (within couple of minutes) each game of the intervention was played.
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Qualitative evaluation of the games in a semi-structured interview (Focus group discussion).
For each game, the same questions will be addressed in an open discussion.
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Assessed every day after (within couple of minutes) each game of the intervention was played.
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Anna-Katharine Brem, University Hospiltal of Old Age Psychiatry and Psychotherapy
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ALZ-RCT-BREM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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