Computerized Cognitive Tests for Early Detection of Alzheimer’s Disease

Overseen By Kathleen Hall, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Neurobehavioral Systems, Inc.

Disqualifiers: Psychiatric disorder, Stroke, Substance abuse, others

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

Compensation: Varies

Number of Visits: 9

2000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial uses computerized cognitive tests to identify early signs of risk for age-related cognitive decline, such as Alzheimer's. Researchers compare performances across different age groups and backgrounds to gather important data for these tests. Participants will be divided into groups to evaluate test reliability and gain insights into health disparities in cognitive testing. Suitable candidates include those without a history of psychiatric disorders, stroke, or substance abuse, and who can use a computer and speak English or Spanish. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could improve early detection methods for 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 prior data suggests that these computerized cognitive tests are safe for participants?

Research has shown that the California Cognitive Assessment Battery (CCAB) has been tested on over 99% of participants with very few problems reported, indicating it is well-tolerated. The CCAB consists of computerized tests that are non-invasive, meaning they don't involve surgery or entering the body.

Studies indicate that the Fast Automated Cognitive Test Battery is generally safe. These computerized tests resemble traditional paper tests but are conducted on a computer, making them easy to take and harmless.

Both the CCAB and the Fast Automated Cognitive Test Battery are designed as simple and safe ways to assess brain function. Since they don't involve risks like medications or surgeries, they are considered safe for use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these computerized cognitive tests because they offer a new way to detect Alzheimer’s disease early. Unlike traditional methods, which often rely on in-person evaluations and can be subjective, these tests provide a fast, automated, and consistent approach, reducing variability in results. Additionally, the study aims to understand health disparities by including diverse participant groups, ensuring the tests are effective across different populations. This could lead to more accurate and accessible screenings for Alzheimer’s, potentially catching signs of the disease earlier than current standard practices.

What evidence suggests that these computerized cognitive tests are effective for early detection of Alzheimer's disease?

Research has shown that the California Cognitive Assessment Battery (CCAB), one of the tools evaluated in this trial, effectively assesses brain function. Studies have found that it aligns well with traditional paper-and-pencil tests, providing a reliable way to test cognitive skills remotely. The Fast Automated Cognitive Test Battery, another tool in this trial, also shows promise. It distinguishes between various levels of memory and cognitive issues, such as dementia and mild cognitive impairment (MCI). Together, these tools offer a comprehensive method to detect early signs of memory and cognitive decline. Both tests are designed to identify subtle changes in brain function, which is crucial for early intervention. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• California Cognitive Assessment Battery
• Fast Automated Cognitive Test Battery

Trial Overview The 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.

How Is the Trial Designed?

Group I: Test-Retest Reliability group Experimental Treatment 1 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 group Experimental Treatment 1 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 group Experimental Treatment 1 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 group Experimental Treatment 1 Intervention

We will compare the performance of normal participants (N = 100, age range 18 to 89) on computerized and manually administered cognitive tasks.

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+

Published Research Related to This Trial

The Inbrain Cognitive Screening Test (Inbrain CST) is a reliable and valid computerized tool for detecting cognitive impairment in elderly individuals, demonstrating good discriminative power between cognitively impaired patients and those with subjective cognitive decline, based on a study involving 97 patients with varying degrees of cognitive decline.

Normative data from 480 cognitively normal elderly participants showed that Inbrain CST scores are influenced by age, education, and gender, and the test's results correlate with specific neuroanatomical changes observed through MRI, supporting its clinical utility in assessing cognitive health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Validation Study of the Inbrain CST: a Tablet Computer-based Cognitive Screening Test for Elderly People with Cognitive Impairment. Chin, J., Kim, DE., Lee, H., et al.[2021]

The Computerized Cognitive Screen (CoCoSc) is a new self-administered test designed to effectively identify cognitive impairment in community settings, showing a strong correlation with the established Montreal Cognitive Assessment (MoCA) (r = 0.71).

With an area under the ROC curve of 0.78, the CoCoSc demonstrates good ability to differentiate between individuals with cognitive impairment and cognitively normal controls, making it a promising tool for early detection in diverse educational backgrounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized Cognitive Screen (CoCoSc): A Self-Administered Computerized Test for Screening for Cognitive Impairment in Community Social Centers. Wong, A., Fong, CH., Mok, VC., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The NIH Toolbox-Cognition and Cogstate-Brief computerized tests effectively identified mild cognitive impairment (MCI) in older adults, distinguishing between healthy controls and different MCI subtypes, with significant results from specific subtests like Flanker and Picture Sequence Memory.

These computer-based tests offer a cost-effective and user-friendly method for early detection of cognitive decline, although further refinement is needed to improve their precision in differentiating between MCI subtypes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mild Cognitive Impairment Subtype Performance in Comparison to Healthy Older Controls on the NIH Toolbox and Cogstate. Garcia, S., Askew, RL., Kavcic, V., et al.[2023]

A systematic review of 11 computerized cognitive tests for the elderly revealed that while all tests demonstrated some reliability and validity, the rigor of their validation varied significantly, indicating the need for careful evaluation of each test.

Computerized cognitive testing offers advantages such as standardized administration, real-time performance comparison, and cost efficiency, making it a promising tool for early detection of cognitive decline in aging populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Status of computerized cognitive testing in aging: a systematic review. Wild, K., Howieson, D., Webbe, F., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The computerized self test (CST): an interactive, internet accessible cognitive screening test for dementia. Dougherty, JH., Cannon, RL., Nicholas, CR., et al.[2010]

The BrainCheck computerized cognitive testing battery demonstrated high diagnostic accuracy, achieving over 88% sensitivity and specificity in distinguishing dementia from normal cognition, and over 77% for mild cognitive impairment (MCI) from both normal cognition and dementia.

With true positive rates of 80% or higher for normal cognition and dementia, and 64% or higher for MCI, BrainCheck shows promise as a reliable tool for early detection of cognitive impairment in a study involving 99 participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Computerized Cognitive Test Battery for Detection of Dementia and Mild Cognitive Impairment: Instrument Validation Study. Ye, S., Sun, K., Huynh, D., 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 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Computerized neurocognitive batteries, such as CogState, CNS Vital Signs, COGDRAS, and Mindstreams, are valuable tools for detecting cognitive impairment in conditions like dementia and Alzheimer's disease.

This review highlights the evolution of these computerized assessments over the last decade, emphasizing their importance in identifying cognitive decline effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized Neurocognitive Test (CNT) in mild cognitive impairment and Alzheimer's disease. de Oliveira, MO., Brucki, SMD.[2020]

In a study of 1439 cognitively unimpaired individuals aged 50-75, the Cogstate Brief Battery (CBB) showed significant practice effects across testing sessions, indicating that repeated testing can improve performance regardless of whether it is done at home or in a clinic.

However, performance varied by location: participants had lower accuracy in the One Card Learning task when tested at home compared to the clinic, while they were faster in the Detection task at home, suggesting that the testing environment can influence cognitive assessment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Stricker, NH., Lundt, ES., Alden, EC., et al.[2021]

Citations

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The California Cognitive Assessment Battery (CCAB) - PMC The CCAB's standardized test instructions and practice trials have enabled the successful testing of more than 99% of all participants, with <1% ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04800588?tab=table

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Validation of Remote Neuropsychological Testing with the ... The CCAB is a valid and reliable means of assessing cognitive functioning in remote settings: Correlations with traditional paper‐and‐pencil tests were strong.

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(PDF) The California Cognitive Assessment Battery (CCAB) Results Here we describe (1) CCAB usability with older (ages 50 to 89) participants; (2) CCAB psychometric properties based on normative data ...

5. alzheimers.gov alzheimers.gov/clinical-trials/computerized-testing-detect-cognitive-decline

Computerized Testing To Detect Cognitive Decline This study will analyze the performance of healthy adults on a series of cognition tests called the California Cognitive Assessment Battery.

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Enhancing early detection of cognitive impairment in ... We evaluated the TabCAT‐Brain Health Assessment (TabCAT‐BHA) digital paradigm to assist with early detection and diagnosis.

7. sciencedirect.com sciencedirect.com/science/article/pii/S227458072400517X

Current State of Self-Administered Brief Computerized ... Targeted evaluation of cognitive impairment can facilitate early detection of cognitive disorders, which in turn can promote patient safety and wellbeing ...