Computerized Tests of Cognitive Decline in Presymptomatic Alzheimer's Disease

NCT ID: NCT04800588

Last Updated: 2025-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-05

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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In Group A, the investigators 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.

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

In Group C, the investigators 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.

In Group D, the investigators will evaluate the performance of healthy older participants (N = 1200, age range 60 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.

Conditions

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Alzheimer Disease Cognitive Decline Aging

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Older participant group

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 Type EXPERIMENTAL

California Cognitive Assessment Battery

Intervention Type DIAGNOSTIC_TEST

The California Cognitive Assessment Battery (CCAB) is a collection of computerized cognitive tests that will be telemedically administered to participants in their homes using a tablet computer and accessories provided by the research team. Testing may also occur in research laboratories. Previous versions of CCAB tests have been described in 16 manuscripts which describe (a) the psychometric characteristics of normative data collected in large participant populations (300 to 2,300 subjects for different tests) and (b) the sensitivity of CCAB tests for detecting performance abnormalities in patients with traumatic brain injury (TBI) and in control participants simulating the cognitive deficits that follow mild TBI.

CCAB vs. manual test group

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

Group Type EXPERIMENTAL

California Cognitive Assessment Battery

Intervention Type DIAGNOSTIC_TEST

The California Cognitive Assessment Battery (CCAB) is a collection of computerized cognitive tests that will be telemedically administered to participants in their homes using a tablet computer and accessories provided by the research team. Testing may also occur in research laboratories. Previous versions of CCAB tests have been described in 16 manuscripts which describe (a) the psychometric characteristics of normative data collected in large participant populations (300 to 2,300 subjects for different tests) and (b) the sensitivity of CCAB tests for detecting performance abnormalities in patients with traumatic brain injury (TBI) and in control participants simulating the cognitive deficits that follow mild TBI.

Test-Retest Reliability group

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 Type EXPERIMENTAL

California Cognitive Assessment Battery

Intervention Type DIAGNOSTIC_TEST

The California Cognitive Assessment Battery (CCAB) is a collection of computerized cognitive tests that will be telemedically administered to participants in their homes using a tablet computer and accessories provided by the research team. Testing may also occur in research laboratories. Previous versions of CCAB tests have been described in 16 manuscripts which describe (a) the psychometric characteristics of normative data collected in large participant populations (300 to 2,300 subjects for different tests) and (b) the sensitivity of CCAB tests for detecting performance abnormalities in patients with traumatic brain injury (TBI) and in control participants simulating the cognitive deficits that follow mild TBI.

Health Disparities group

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 Type EXPERIMENTAL

California Cognitive Assessment Battery

Intervention Type DIAGNOSTIC_TEST

The California Cognitive Assessment Battery (CCAB) is a collection of computerized cognitive tests that will be telemedically administered to participants in their homes using a tablet computer and accessories provided by the research team. Testing may also occur in research laboratories. Previous versions of CCAB tests have been described in 16 manuscripts which describe (a) the psychometric characteristics of normative data collected in large participant populations (300 to 2,300 subjects for different tests) and (b) the sensitivity of CCAB tests for detecting performance abnormalities in patients with traumatic brain injury (TBI) and in control participants simulating the cognitive deficits that follow mild TBI.

Interventions

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California Cognitive Assessment Battery

The California Cognitive Assessment Battery (CCAB) is a collection of computerized cognitive tests that will be telemedically administered to participants in their homes using a tablet computer and accessories provided by the research team. Testing may also occur in research laboratories. Previous versions of CCAB tests have been described in 16 manuscripts which describe (a) the psychometric characteristics of normative data collected in large participant populations (300 to 2,300 subjects for different tests) and (b) the sensitivity of CCAB tests for detecting performance abnormalities in patients with traumatic brain injury (TBI) and in control participants simulating the cognitive deficits that follow mild TBI.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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CCAB

Eligibility Criteria

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Inclusion Criteria

* Must be able to use computer mouse and touch screen
* Must speak English as a primary language
* Must speak Spanish as a primary language (for Latino participants completing our Spanish translation)

Exclusion Criteria

* History of psychiatric disorder
* History of stroke or transient ischemic attack
* History of substance abuse
* History of medical or sensory disorders that are incompatible with effective testing
* History of traumatic brain injury with hospitalization and extended loss of consciousness
* History of epilepsy
* History of depression or anxiety
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Neurobehavioral Systems, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Neurobehavioral Systems, Inc.

Berkeley, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kathleen Hall, PhD

Role: CONTACT

510-214-3176

David Woods

Role: CONTACT

5105279231

Facility Contacts

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Kathleen Hall, PhD

Role: primary

510-214-3176

Isabella Coordinator

Role: backup

References

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Woods DL, Kishiyamaa MM, Lund EW, Herron TJ, Edwards B, Poliva O, Hink RF, Reed B. Improving digit span assessment of short-term verbal memory. J Clin Exp Neuropsychol. 2011 Jan;33(1):101-11. doi: 10.1080/13803395.2010.493149.

Reference Type BACKGROUND
PMID: 20680884 (View on PubMed)

Woods DL, Herron TJ, Yund EW, Hink RF, Kishiyama MM, Reed B. Computerized analysis of error patterns in digit span recall. J Clin Exp Neuropsychol. 2011 Aug;33(7):721-34. doi: 10.1080/13803395.2010.550602.

Reference Type BACKGROUND
PMID: 21957866 (View on PubMed)

Woods DL, Wyma JM, Herron TJ, Yund EW. The Effects of Repeat Testing, Malingering, and Traumatic Brain Injury on Computerized Measures of Visuospatial Memory Span. Front Hum Neurosci. 2016 Jan 5;9:690. doi: 10.3389/fnhum.2015.00690. eCollection 2015.

Reference Type BACKGROUND
PMID: 26779001 (View on PubMed)

Woods DL, Wyma JM, Herron TJ, Yund EW. An improved spatial span test of visuospatial memory. Memory. 2016 Sep;24(8):1142-55. doi: 10.1080/09658211.2015.1076849. Epub 2015 Sep 11.

Reference Type BACKGROUND
PMID: 26357906 (View on PubMed)

Woods DL, Wyma JM, Herron TJ, Yund EW. The Bay Area Verbal Learning Test (BAVLT): Normative Data and the Effects of Repeated Testing, Simulated Malingering, and Traumatic Brain Injury. Front Hum Neurosci. 2017 Jan 12;10:654. doi: 10.3389/fnhum.2016.00654. eCollection 2016.

Reference Type BACKGROUND
PMID: 28127280 (View on PubMed)

Woods DL, Wyma JM, Herron TJ, Yund EW, Reed B. The Dyad-Adaptive Paced Auditory Serial Addition Test (DA-PASAT): Normative data and the effects of repeated testing, simulated malingering, and traumatic brain injury. PLoS One. 2018 Apr 20;13(4):e0178148. doi: 10.1371/journal.pone.0178148. eCollection 2018.

Reference Type BACKGROUND
PMID: 29677192 (View on PubMed)

Woods DL, Wyma JM, Herron TJ, Yund EW. The Effects of Aging, Malingering, and Traumatic Brain Injury on Computerized Trail-Making Test Performance. PLoS One. 2015 Jun 10;10(6):e0124345. doi: 10.1371/journal.pone.0124345. eCollection 2015.

Reference Type BACKGROUND
PMID: 26060999 (View on PubMed)

Woods DL, Wyma JM, Yund EW, Herron TJ, Reed B. Factors influencing the latency of simple reaction time. Front Hum Neurosci. 2015 Mar 26;9:131. doi: 10.3389/fnhum.2015.00131. eCollection 2015.

Reference Type BACKGROUND
PMID: 25859198 (View on PubMed)

Woods DL, Wyma JM, Yund EW, Herron TJ. The Effects of Repeated Testing, Simulated Malingering, and Traumatic Brain Injury on High-Precision Measures of Simple Visual Reaction Time. Front Hum Neurosci. 2015 Nov 9;9:540. doi: 10.3389/fnhum.2015.00540. eCollection 2015.

Reference Type BACKGROUND
PMID: 26617505 (View on PubMed)

Hubel KA, Reed B, Yund EW, Herron TJ, Woods DL. Computerized measures of finger tapping: effects of hand dominance, age, and sex. Percept Mot Skills. 2013 Jun;116(3):929-52. doi: 10.2466/25.29.PMS.116.3.929-952.

Reference Type BACKGROUND
PMID: 24175464 (View on PubMed)

Hubel KA, Yund EW, Herron TJ, Woods DL. Computerized measures of finger tapping: reliability, malingering and traumatic brain injury. J Clin Exp Neuropsychol. 2013;35(7):745-58. doi: 10.1080/13803395.2013.824070. Epub 2013 Aug 15.

Reference Type BACKGROUND
PMID: 23947782 (View on PubMed)

Woods DL, Wyma JM, Yund EW, Herron TJ. The Effects of Repeated Testing, Simulated Malingering, and Traumatic Brain Injury on Visual Choice Reaction Time. Front Hum Neurosci. 2015 Nov 24;9:595. doi: 10.3389/fnhum.2015.00595. eCollection 2015.

Reference Type BACKGROUND
PMID: 26635569 (View on PubMed)

Woods DL, Wyma JM, Yund EW, Herron TJ, Reed B. Age-related slowing of response selection and production in a visual choice reaction time task. Front Hum Neurosci. 2015 Apr 23;9:193. doi: 10.3389/fnhum.2015.00193. eCollection 2015.

Reference Type BACKGROUND
PMID: 25954175 (View on PubMed)

Woods DL, Wyma JM, Herron TJ, Yund EW. Computerized Analysis of Verbal Fluency: Normative Data and the Effects of Repeated Testing, Simulated Malingering, and Traumatic Brain Injury. PLoS One. 2016 Dec 9;11(12):e0166439. doi: 10.1371/journal.pone.0166439. eCollection 2016.

Reference Type BACKGROUND
PMID: 27936001 (View on PubMed)

Woods DL, Wyma JM, Herron TJ, Yund EW. A Computerized Test of Design Fluency. PLoS One. 2016 May 3;11(5):e0153952. doi: 10.1371/journal.pone.0153952. eCollection 2016.

Reference Type BACKGROUND
PMID: 27138985 (View on PubMed)

Woods DL, Yund EW, Wyma JM, Ruff R, Herron TJ. Measuring executive function in control subjects and TBI patients with question completion time (QCT). Front Hum Neurosci. 2015 May 19;9:288. doi: 10.3389/fnhum.2015.00288. eCollection 2015.

Reference Type BACKGROUND
PMID: 26042021 (View on PubMed)

Other Identifiers

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4R44AG062076

Identifier Type: NIH

Identifier Source: org_study_id

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