Cognitive DeclineNCT06090942
Cognitive Training for Digital Biomarkers
A study testing Smartphone-based cognitive training in people with Cognitive Decline and Healthy Aging, run by Taipei Medical University.
Trial summary
This study aims to conduct cognitive training for digital biomarkers among older adults. Read more about this study
- Who is it for?
- Ages 60 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline, Healthy Aging
- What is being tested?
- Smartphone-based cognitive training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2023to 31 Jul 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 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 60 years of age, Can communicate in Chinese (Taiwanese)
- Bring your own mobile device with Internet access.
- Can act alone without physical impairment；full score of basic activities of daily living scale and instrumental activities of daily living scale.
Who cannot join
- Dementia diagnosed by a physician and in compliance with ICD-10
- Physician diagnosed with significant mental illness or communication impairment
- Participated in other cognitive training studies within the past year
- Medical conditions associated with rapid functional and cognitive decline
- Severe visual impairment
About this study
Official title: The Effectiveness of Cognitive Training for Digital Biomarkers: Evidence From the Urban and Rural Area
This study aims to conduct cognitive training for digital biomarkers among older adults.
Read the detailed description
The prevalence of dementia in rural areas is higher than in urban areas. However, the resource and research input on cognitive training for rural older adults still needs improvement. There is also no solution for preventing or early detection of dementia in rural areas. Unlike biomarkers that require invasive detection, digital biomarkers have been advocated in recent years for early disease prediction. However, there are still few studies on the effectiveness of digital biomarkers in evaluating cognitive function in the elderly. In addition, although previous studies have confirmed that cognitive training can be effective for older adults, it is difficult for the elderly in rural areas to obtain these cognitive-promoting resources due to distance. Moreover, the autonomy and right of choice of older adults are the keys to the success of their health behavior change.
- Conditions
- Cognitive Decline, Healthy Aging
- Being tested
- Smartphone-based cognitive training
- Keywords
- digital biomarker
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone-based cognitive trainingOther
Smartphone-based cognitive training
| Study group | Role | What they receive |
|---|---|---|
| Cognitive training | Experimental | Smartphone-based cognitive training Receives: Other: Smartphone-based cognitive training |
| Usual care | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
digital biomarker
wearable device of stress and sleep, EEG power in alpha band, Delta and Theta frequency-bands
Measured: pretest, immediate post test, 3 month follow-up, 6 month follow-up
Secondary outcomes (5)
Montreal Cognitive Assessment(MoCA)
The Montreal Cognitive Assessment (MoCA) is a cognitive screening tool designed to identify mild cognitive impairment, providing a quick assessment of different cognitive domains including memory, attention, language, and executive functions. It is widely utilized in clinical and research settings.The MoCA is scored out of a maximum of 30 points. A score of 26 and above is generally considered to be normal, although the specific cutoff can depend on the individual's age, educational level, and other demographic factors.
Measured: pretest, immediate post test, 3 month follow-up, 6 month follow-up
Digit Span(DS)
Digit Span (DS) is a common test used in neuropsychological assessments to measure working memory, attention, and concentration. Each correctly repeated sequence yields one point. There are typically 16 items for the Forward Digit Span. The Backward Digit Span also has 16 items.
Measured: pretest, immediate post test, 3 month follow-up, 6 month follow-up
Digit Vigilance Test(DVT)
The Digit Vigilance Test (DVT) is a psychological assessment tool used to measure attention and concentration, mainly focused on visual scanning and processing speed. The number of correct identifications and the time taken to complete the task are typically measured.
Measured: pretest, immediate post test, 3 month follow-up, 6 month follow-up
Computerized version of Wisconsin Card Sort Test (WCST)
The Wisconsin Card Sorting Test (WCST) is a well-established neuropsychological test widely used to assess executive functions, mainly focusing on abstract reasoning and the ability to shift cognitive strategies in response to changing environmental contingencies (i.e., set-shifting or cognitive flexibility). The computerized version of the WCST allows for efficient, standardized administration and scoring, often reducing examiner bias and error.
Measured: pretest, immediate post test, 3 month follow-up, 6 month follow-up
Stroop color-word test (SCWT)
The Stroop Color-Word Test (SCWT) evaluates cognitive processing speed, selective attention, and cognitive flexibility, which are aspects of executive functioning. It's particularly notable for its ability to detect cognitive interference and inhibition control.Scores are typically based on:Correct Responses, Time Taken, Error Rate and Interference Score.
Measured: pretest, immediate post test, 3 month follow-up, 6 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 posted19 Oct 2023
- Study start20 Oct 2023 (estimated)
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huie-Ling Chiu, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090942
- Sponsor's protocol ID
- N202303103
- Status last verified
- Oct 2023
- First submitted
- 16 Aug 2023
- Last updated
- 19 Oct 2023
- 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 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Cognitive Training for Digital Biomarkers: Evidence From the Urban and Rural Area
- ClinicalTrials.gov ID
- NCT06090942
- Acronym / sponsor ID
- N202303103
- Conditions
- Cognitive Decline, Healthy Aging
- Keywords
- digital biomarker
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 20 Oct 2023 (estimated)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 19 Oct 2023 (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.
This study aims to conduct cognitive training for digital biomarkers among older adults.
Detailed description
The prevalence of dementia in rural areas is higher than in urban areas. However, the resource and research input on cognitive training for rural older adults still needs improvement. There is also no solution for preventing or early detection of dementia in rural areas. Unlike biomarkers that require invasive detection, digital biomarkers have been advocated in recent years for early disease prediction. However, there are still few studies on the effectiveness of digital biomarkers in evaluating cognitive function in the elderly. In addition, although previous studies have confirmed that cognitive training can be effective for older adults, it is difficult for the elderly in rural areas to obtain these cognitive-promoting resources due to distance. Moreover, the autonomy and right of choice of older adults are the keys to the success of their health behavior change.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive training | Experimental | Other: Smartphone-based cognitive trainingSmartphone-based cognitive training |
| Usual care | No intervention | –No intervention |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 60 years of age, Can communicate in Chinese (Taiwanese)
- Bring your own mobile device with Internet access.
- Can act alone without physical impairment；full score of basic activities of daily living scale and instrumental activities of daily living scale.
Key exclusion criteria (5 listed)
- Dementia diagnosed by a physician and in compliance with ICD-10
- Physician diagnosed with significant mental illness or communication impairment
- Participated in other cognitive training studies within the past year
- Medical conditions associated with rapid functional and cognitive decline
- Severe visual impairment
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 |
|---|---|---|
| Smartphone-based cognitive trainingSmartphone-based cognitive training | Other | Cognitive training |
Primary outcome
digital biomarker
Time frame: pretest, immediate post test, 3 month follow-up, 6 month follow-up
wearable device of stress and sleep, EEG power in alpha band, Delta and Theta frequency-bands
5 secondary outcomes
Montreal Cognitive Assessment(MoCA)
Time frame: pretest, immediate post test, 3 month follow-up, 6 month follow-up
Digit Span(DS)
Time frame: pretest, immediate post test, 3 month follow-up, 6 month follow-up
Digit Vigilance Test(DVT)
Time frame: pretest, immediate post test, 3 month follow-up, 6 month follow-up
Computerized version of Wisconsin Card Sort Test (WCST)
Time frame: pretest, immediate post test, 3 month follow-up, 6 month follow-up
Stroop color-word test (SCWT)
Time frame: pretest, immediate post test, 3 month follow-up, 6 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 19 Oct 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone-based cognitive training in people with Cognitive Decline and Healthy Aging, run by Taipei Medical University.
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 5 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 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
digital biomarker (time frame: pretest, immediate post test, 3 month follow-up, 6 month follow-up). 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 19 Oct 2023.