2000 Participants Needed

Computerized Cognitive Tests for Early Detection of Alzheimer’s Disease

DW
JM
GW
Overseen ByGarrett Williams
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Neurobehavioral Systems, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The investigators will study performance on computerized cognitive tasks in healthy participants of different ages to gather normative data for newly developed computerized cognitive tests. These tests are designed to permit the early detection of individuals at risk of age-related cognitive decline.

Do I need to stop taking my current medications for the trial?

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

What data supports the effectiveness of the treatment California Cognitive Assessment Battery (CCAB) and similar computerized cognitive tests for early detection of Alzheimer's disease?

Research shows that computerized cognitive tests, like the Computerized Self Test (CST) and the Cogstate Brief Battery (CBB), are effective in identifying cognitive impairment related to Alzheimer's disease. The CST accurately classified 96% of cognitively impaired individuals, outperforming traditional tests like the Mini-Mental Status Examination. Similarly, the CBB has been shown to detect early cognitive impairment in people at risk for Alzheimer's, making these tools promising for early detection.12345

Is it safe to participate in computerized cognitive tests for Alzheimer's detection?

The research does not provide specific safety data for computerized cognitive tests, but these tests are generally non-invasive and similar to traditional paper-based cognitive assessments, suggesting they are likely safe for human use.12367

How does the computerized cognitive test differ from other treatments for Alzheimer's disease?

The computerized cognitive test is unique because it offers an accessible, low-cost, and self-administered method for early detection of Alzheimer's disease, unlike traditional treatments that focus on managing symptoms. It eliminates the need for a rater, saving time and providing immediate results, which is not typical of other cognitive assessments.1891011

Eligibility Criteria

This trial is for healthy individuals who can use a computer mouse and touchscreen, and speak English or Spanish as their primary language. It's not suitable for those with psychiatric disorders, stroke history, substance abuse, medical conditions affecting testing, traumatic brain injury with hospitalization and extended unconsciousness, epilepsy, depression or anxiety.

Inclusion Criteria

Spanish is my primary language.
I can use a computer mouse and touch screen.
I can use a computer mouse and touch screen.
See 1 more

Exclusion Criteria

History of medical or sensory disorders that are incompatible with effective testing
You have a history of mental health issues.
I have a history of depression or anxiety.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment

Participants undergo initial cognitive testing for three days to gather baseline data

3 days
3 visits (in-person)

Longitudinal Testing

Participants are tested at 6-month intervals to collect longitudinal normative data

3 years
6 visits (in-person) per year

Follow-up

Participants are monitored for changes in cognitive performance over time

6 months

Treatment Details

Interventions

  • California Cognitive Assessment Battery
  • Fast Automated Cognitive Test Battery
Trial OverviewThe study involves performing tasks on a computer to collect standard data for new cognitive tests. These tests aim to identify early signs of age-related cognitive decline potentially leading to Alzheimer's disease in people before symptoms appear.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: Test-Retest Reliability groupExperimental Treatment1 Intervention
We will gather normative data from participants across the age range (N = 100, ages 18 to 89) for three days at enrollment, to better characterize test-retest reliability scores on Day 1 tasks.
Group II: Older participant groupExperimental Treatment1 Intervention
We will evaluate the performance of healthy older participants (N = 300, age range 60 to 89 years) for three days at enrollment and then at 6-month intervals for three years thereafter. The goal is to characterize changes in performance to aging and task experience in a group of older subjects.
Group III: Health Disparities groupExperimental Treatment1 Intervention
We will evaluate the performance of healthy older participants (N = 1200, age range 50 to 89 years) for three days at enrollment and then at 6-month intervals for three years thereafter. In the aim of better understanding health disparities in cognitive testing, this group will be divided into four cohorts: 300 African American participants; 300 Asian American participants; 300 Latino English-speaking participants; and 300 Latino Spanish-speaking participants, who will complete a Spanish translation of our computerized cognitive tests.
Group IV: CCAB vs. manual test groupExperimental Treatment1 Intervention
We will compare the performance of normal participants (N = 100, age range 18 to 89) on computerized and manually administered cognitive tasks.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Neurobehavioral Systems, Inc.

Lead Sponsor

Trials
1
Recruited
2,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Findings from Research

The Computer Self Test (CST) demonstrated a high accuracy rate of 96% in identifying cognitively impaired individuals compared to controls, significantly outperforming traditional tests like the Mini-Mental Status Examination (71%) and Mini-Cog (69%).
With a sample size of 215 participants, including 84 diagnosed with Alzheimer's disease, the CST effectively classified various stages of cognitive impairment, suggesting it could be a valuable tool for early detection and monitoring of cognitive changes in primary care settings.
The computerized self test (CST): an interactive, internet accessible cognitive screening test for dementia.Dougherty, JH., Cannon, RL., Nicholas, CR., et al.[2010]
The Cogstate Brief Battery (CBB) effectively identifies cognitive impairment related to Alzheimer's disease (AD) in older adults, demonstrating high sensitivity and specificity, particularly in distinguishing between mild cognitive impairment (MCI) and dementia.
The Learning and Working Memory (LWM) composite score from the CBB showed the strongest sensitivity for detecting cognitive deficits, with an area under the curve (AUC) of 0.90 for MCI and 0.97 for dementia, indicating its potential as a reliable tool in clinical settings.
Sensitivity of Individual and Composite Test Scores from the Cogstate Brief Battery to Mild Cognitive Impairment and Dementia Due to Alzheimer's Disease.White, JP., Schembri, A., Prenn-Gologranc, C., et al.[2023]
In a study of 469 late middle-aged participants, the CogState abbreviated battery (CAB) effectively identified early cognitive impairment related to Alzheimer's disease, showing strong correlations with traditional neuropsychological tests and cognitive impairment indices.
The CAB demonstrated sensitivity to cognitive changes associated with Alzheimer's pathology, as poorer performance on the One Card Learning test was linked to higher levels of CSF phosphorylated-tau/Aβ42, indicating its potential as a useful tool for early detection in at-risk individuals.
Associations between Performance on an Abbreviated CogState Battery, Other Measures of Cognitive Function, and Biomarkers in People at Risk for Alzheimer's Disease.Racine, AM., Clark, LR., Berman, SE., et al.[2022]

References

The computerized self test (CST): an interactive, internet accessible cognitive screening test for dementia. [2010]
Sensitivity of Individual and Composite Test Scores from the Cogstate Brief Battery to Mild Cognitive Impairment and Dementia Due to Alzheimer's Disease. [2023]
Associations between Performance on an Abbreviated CogState Battery, Other Measures of Cognitive Function, and Biomarkers in People at Risk for Alzheimer's Disease. [2022]
Development and evaluation of a computerized test battery for Alzheimer's disease screening in community-based settings. [2019]
Status of computerized cognitive testing in aging: a systematic review. [2022]
Longitudinal Comparison of in Clinic and at Home Administration of the Cogstate Brief Battery and Demonstrated Practice Effects in the Mayo Clinic Study of Aging. [2021]
Mild Cognitive Impairment Subtype Performance in Comparison to Healthy Older Controls on the NIH Toolbox and Cogstate. [2023]
A Computerized Cognitive Test Battery for Detection of Dementia and Mild Cognitive Impairment: Instrument Validation Study. [2022]
A Validation Study of the Inbrain CST: a Tablet Computer-based Cognitive Screening Test for Elderly People with Cognitive Impairment. [2021]
Computerized Neurocognitive Test (CNT) in mild cognitive impairment and Alzheimer's disease. [2020]
Computerized Cognitive Screen (CoCoSc): A Self-Administered Computerized Test for Screening for Cognitive Impairment in Community Social Centers. [2019]