ClinicalTrials.gg
Status unknownNCT06090942Updated Oct 19, 2023

Cognitive Training for Digital Biomarkers

An interventional study of Smartphone-based cognitive training in Cognitive Decline and Healthy Aging, sponsored by Taipei Medical University. Status unknown. Open to participants aged 60 Years to 95 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-19.

Sponsored by Taipei Medical University · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Oct 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
60 Years to 95 Years
Sex
All
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Study summary

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.

02

Conditions studied

  • Cognitive Decline
  • Healthy Aging

Keywords

  • digital biomarker
03

In context

Cognitive Dysfunction

3,930 studies on the registry are indexed under Cognitive Dysfunction; 1,114 are open to participants now.

This study's planned enrollment of 90 is above the median of 64 across 2,855 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Lead sponsor

Taipei Medical University is the lead sponsor of 256 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. At least 60 years of age, Can communicate in Chinese (Taiwanese)
  2. Bring your own mobile device with Internet access.
  3. Can act alone without physical impairment;full score of basic activities of daily living scale and instrumental activities of daily living scale.

Exclusion criteria

Exclusion Criteria:

  1. Dementia diagnosed by a physician and in compliance with ICD-10
  2. Physician diagnosed with significant mental illness or communication impairment
  3. Participated in other cognitive training studies within the past year
  4. Medical conditions associated with rapid functional and cognitive decline
  5. Severe visual impairment
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Cognitive training

    Smartphone-based cognitive training

    Other: Smartphone-based cognitive training

  • No intervention
    Usual care

    No intervention

Interventions

  • OtherSmartphone-based cognitive training

    Smartphone-based cognitive training

06

What researchers measure

Primary outcomes

  1. digital biomarker

    wearable device of stress and sleep, EEG power in alpha band, Delta and Theta frequency-bands

    Time frame: pretest, immediate post test, 3 month follow-up, 6 month follow-up

Secondary outcomes

  1. 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.

    Time frame: pretest, immediate post test, 3 month follow-up, 6 month follow-up

  2. 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.

    Time frame: pretest, immediate post test, 3 month follow-up, 6 month follow-up

  3. 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.

    Time frame: pretest, immediate post test, 3 month follow-up, 6 month follow-up

  4. 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.

    Time frame: pretest, immediate post test, 3 month follow-up, 6 month follow-up

  5. 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.

    Time frame: pretest, immediate post test, 3 month follow-up, 6 month follow-up

07

Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2023; primary completion for Jul 2024, 9 months later.

Of 1,439 non-industry interventional studies with no phase under Cognitive Dysfunction, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 51. This study's planned 9 months is below that.

Counting every sponsor, half of 1,512 studies reached it within 26 months; a quarter within 12 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 16, 2023
First posted
Oct 19, 2023
StartEst.
Oct 20, 2023
Primary completionEst.
Jul 31, 2024
CompletionEst.
Jul 31, 2024
Last update
Oct 19, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06090942
Responsible party
Huie-Ling Chiu (Associate professor, Taipei Medical University) — Principal investigator
First posted
Oct 19, 2023
Start date
Oct 20, 2023 (estimated)
Primary completion
Jul 31, 2024 (estimated)
Completion
Jul 31, 2024 (estimated)
Last update
Oct 19, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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