TabCAT Assessment for Dementia

Overseen By Katherine Possin, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Under 18

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 9 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

180000 Participants Needed

Trial Summary

What is the purpose of this trial?

Efficient and user-friendly paradigms to detect cognitive impairment, including dementia are needed in primary care. The TabCAT Brain Health Assessment accurately detects cognitive impairment via an appealing tablet interface with automated scoring and EMR integration. This study will evaluate the effectiveness of the paradigm on detection rates and other brain health outcomes via a pragmatic cluster randomized trial in 26 Kaiser Southern California primary care clinics.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the TabCAT Brain Health Assessment treatment for dementia?

Research shows that tablet-based cognitive tests, like the TabCAT Brain Health Assessment, are effective in identifying early cognitive impairment in older adults, including those with mild cognitive impairment and Alzheimer's disease. These tests are quick to administer and have been shown to correlate well with traditional cognitive assessments, making them a valid tool for evaluating cognition. ^{1 2 3 4 5}

Is the TabCAT Assessment for Dementia safe for humans?

The available research does not provide specific safety data for the TabCAT Assessment for Dementia, but it suggests that using mobile devices for cognitive assessments is generally considered feasible and viable, with concerns mainly about privacy and test validation rather than safety. ^{2 6 7 8 9}

How is the TabCAT Brain Health Assessment treatment different from other treatments for dementia?

The TabCAT Brain Health Assessment is unique because it uses a tablet-based approach to evaluate cognitive functions like memory and attention, making it a quick and accessible tool for identifying early cognitive impairment in older adults. ^{3 4 10 11 12}

Research Team

Katherine Possin, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for adults who have visited one of the 26 participating primary care clinics in Southern California during the study period. It's focused on those aged 65 and older for the main analysis but includes adults over 18. Children under 18 cannot participate.

Inclusion Criteria

I am 18 years old or older.

Patient with at least one encounter at an intervention clinic during the intervention period

Exclusion Criteria

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Startup

Research team partners with physician leads to adapt the paradigm workflows and onboard PCPs

6 months

Steady State

Effectiveness on primary and secondary outcomes measured; TabCAT-BHA assessments conducted

12 months

Follow-up

Participants are monitored for cognitive assessment and referrals post-intervention

4 months

Treatment Details

Interventions

• TabCAT Brain Health Assessment

Trial Overview The TabCAT Brain Health Assessment, a tablet-based tool designed to detect cognitive impairments including dementia, is being tested. The study aims to see if this user-friendly technology with automatic scoring improves detection rates in a real-world clinic setting.

Participant Groups

Group I: TabCAT-Brain Health Assessment Clinical Pathway Experimental Treatment 1 Intervention

Primary care providers concerned that their patients are exhibiting signs of cognitive decline based on patient, informant (family), or provider concerns will refer them for a TabCAT-BHA assessment and follow-up care.

Group II: Usual Care Clinical Pathway Active Control 1 Intervention

Patients in the control practices will continue with usual care workflows.

TabCAT Brain Health Assessment is already approved in United States, Brazil for the following indications:

Approved in United States as TabCAT-BHA for:

• Detection of mild cognitive impairment
• Detection of dementia

Approved in Brazil as TabCAT-BHA for:

• Detection of mild cognitive impairment
• Detection of dementia

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Kaiser Permanente

Collaborator

Trials

563

Recruited

27,400,000+

Findings from Research

A survey of 48 participants, including people with cognitive impairment, caregivers, and healthcare professionals, revealed a strong interest in using mHealth apps to improve memory, assist with medication management, and enhance ease of use.

All groups involved believe that mHealth apps, particularly brain games and geolocation tracking, could significantly support dementia care and help manage cognitive decline, despite concerns about privacy from patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human Factors and Requirements of People with Cognitive Impairment, Their Caregivers, and Healthcare Professionals for mHealth Apps Including Reminders, Games, and Geolocation Tracking: A Survey-Questionnaire Study. Lazarou, I., Stavropoulos, TG., Mpaltadoros, L., et al.[2022]

In a study involving 640 eligible participants aged 75 and older, three different assessment methods for dementia prevention trials were tested, including mail-in questionnaires, automated telephone interviews, and internet-based kiosks.

The internet-based kiosk method had the highest dropout rates and required more staff time, but the study suggests that these efficiency differences may lessen over the course of a long-term trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing dementia prevention trials: baseline report of the Home-Based Assessment study. Sano, M., Egelko, S., Donohue, M., et al.[2021]

A new tablet-based cognitive test battery was developed to effectively identify early cognitive impairment in older adults, showing significant correlations with established cognitive assessments like the Mini-Mental State Examination.

The test battery demonstrated that individuals with probable Alzheimer's disease scored lower in 8 out of 13 cognitive areas, while those with mild cognitive impairment scored lower in 4 areas, indicating its potential for early detection of cognitive decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validity of a Novel Touch Screen Tablet-Based Assessment for Mild Cognitive Impairment and Probable AD in Older Adults. Huang, YP., Singh, A., Chen, S., et al.[2020]

In a study involving 54 Alzheimer's patients, performance on the Dementia Assessment Battery improved with repeated testing, highlighting the potential for practice effects in cognitive assessments.

The research identified that impairments in visuo-spatial and verbal abilities were independent, with working memory fragility being a key factor in poor recall, emphasizing the need for detailed individual assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alzheimer's dementia: performance on parallel forms of the dementia assessment battery. Teng, EL., Wimer, C., Roberts, E., et al.[2013]

The study evaluated mobile app-based cognitive tasks in 172 older adults, showing that these tasks are feasible and valid for assessing cognitive function, with moderate correlations to traditional cognitive tests.

While the tasks demonstrated moderate reliability over repeated sessions, challenges such as task completion timing and perceived difficulty were noted, suggesting the need for improvements in future implementations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unsupervised mobile app-based cognitive testing in a population-based study of older adults born 1944. Öhman, F., Berron, D., Papp, KV., et al.[2022]

Mobile apps that track cognitive health data have the potential to serve as effective screening tools for early detection of Alzheimer's disease, based on a review of 25 relevant studies.

Despite their promise, the use of these apps for cognitive screening is still underdeveloped, with concerns about their validity and privacy issues, indicating a need for further research and development in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An update on mobile applications collecting data among subjects with or at risk of Alzheimer's disease. Piendel, L., Vališ, M., Hort, J.[2023]

The C3-PAD cognitive assessment can be reliably performed at home by older adults, with 57% of participants completing all at-home tests correctly, indicating its feasibility for use outside clinical settings.

At-home C3-PAD assessments showed strong reliability and were highly correlated with in-clinic assessments, suggesting that they can provide valid cognitive data comparable to traditional neuropsychological tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Feasibility of At-Home iPad Cognitive Testing For Use in Clinical Trials. Rentz, DM., Dekhtyar, M., Sherman, J., et al.[2022]

In a study involving 95 participants, including 70 with Parkinson's disease (PD), it was found that functional strength activities significantly improved neurocognitive performance in early-stage PD, while aerobic activities were more beneficial for advanced stages of the disease.

The research highlights the potential of mobile-based assessments to tailor physical intervention programs to specific symptoms and stages of PD, paving the way for personalized treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards Symptom-Specific Intervention Recommendation Systems. Templeton, JM., Poellabauer, C., Schneider, S.[2022]

Emerging digital tools, including apps and wearables, can facilitate large-scale self-assessment of cognitive performance, particularly for detecting mild cognitive impairment (MCI), which is a risk factor for dementia.

These tools can be passive (monitoring behavior without user input) or interactive (requiring user input), potentially improving access to cognitive assessments outside of traditional clinical settings, although challenges like test validation and user experience need to be addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Detection of Mild Cognitive Impairment (MCI) in an At-Home Setting. Sabbagh, MN., Boada, M., Borson, S., et al.[2022]

The iPad version of the NIH Toolbox Cognition Battery (NIHTB-CB) effectively measures cognitive functioning in older adults, showing improvements in fluid cognitive abilities over a 4-week period in a study of 51 participants aged 55 and older.

While crystallized cognitive measures remained stable, the study found that response times improved for certain tests, indicating that the NIHTB-CB could help detect subtle cognitive changes in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of the iPad NIH Toolbox Cognition Battery in a clinical trial of older adults. Parsey, CM., Bagger, JE., Trittschuh, EH., et al.[2022]

A newly developed computerized test battery effectively differentiates between individuals with Alzheimer's disease and healthy elderly individuals, achieving a high sensitivity of 96% and specificity of 86%.

The study involved 72 participants diagnosed with Alzheimer's and 102 healthy elderly individuals, demonstrating that the test battery can be a valuable tool for routine screening in clinical and community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and evaluation of a computerized test battery for Alzheimer's disease screening in community-based settings. Inoue, M., Jinbo, D., Nakamura, Y., et al.[2019]

The Cognitive Assessment for Dementia, iPad version (CADi), has been shown to effectively differentiate between dementia patients and healthy elderly individuals, indicating its potential as a reliable screening tool.

The CADi demonstrated good reliability and validity, with acceptable Cronbach's alpha values and significant test-retest reliability over a one-year period, making it suitable for mass screening in Japanese populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of a new mass screening tool for cognitive impairment: Cognitive Assessment for Dementia, iPad version. Onoda, K., Hamano, T., Nabika, Y., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Human Factors and Requirements of People with Cognitive Impairment, Their Caregivers, and Healthcare Professionals for mHealth Apps Including Reminders, Games, and Geolocation Tracking: A Survey-Questionnaire Study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Developing dementia prevention trials: baseline report of the Home-Based Assessment study. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Validity of a Novel Touch Screen Tablet-Based Assessment for Mild Cognitive Impairment and Probable AD in Older Adults. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Alzheimer's dementia: performance on parallel forms of the dementia assessment battery. [2013]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Unsupervised mobile app-based cognitive testing in a population-based study of older adults born 1944. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

An update on mobile applications collecting data among subjects with or at risk of Alzheimer's disease. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

The Feasibility of At-Home iPad Cognitive Testing For Use in Clinical Trials. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Towards Symptom-Specific Intervention Recommendation Systems. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Early Detection of Mild Cognitive Impairment (MCI) in an At-Home Setting. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Utility of the iPad NIH Toolbox Cognition Battery in a clinical trial of older adults. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Development and evaluation of a computerized test battery for Alzheimer's disease screening in community-based settings. [2019]

12. New Zealand pubmed.ncbi.nlm.nih.gov

Validation of a new mass screening tool for cognitive impairment: Cognitive Assessment for Dementia, iPad version. [2022]