Computerized Tests of Cognitive Decline in Presymptomatic Alzheimer's Disease

NCT04800588 | Recruiting

• 1 other identifier: 4R44AG062076
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alzheimer Disease; Cognitive Decline; Aging

Keywords

Aging; Elderly; Alzheimer's disease; Cognition; Computerized; Testing

Outcome Measures

Primary Outcomes (1)

• Longitudinal normative data collection from healthy participants

  Multiple behavioral outcome measures will be obtained from each cognitive test including measures of response time (in milliseconds) and accuracy (in percent correct). Recordings of subject's verbal responses will also be analyzed phonologically and automatically transcribed to permit the lexical, syntactic, and semantic analysis of speech output. Questionnaire data will be used to identify factors that may influence performance on the cognitive tests. The primary outcome measures are the scores obtained during enrollment testing that predict a decline in longitudinal performance.

  Longitudinal testing at six-month intervals

Study Arms (4)

Older participant group

EXPERIMENTAL

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.

Diagnostic Test: California Cognitive Assessment Battery

CCAB vs. manual test group

EXPERIMENTAL

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

Diagnostic Test: California Cognitive Assessment Battery

Test-Retest Reliability group

EXPERIMENTAL

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.

Diagnostic Test: California Cognitive Assessment Battery

Health Disparities group

EXPERIMENTAL

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.

Diagnostic Test: California Cognitive Assessment Battery

Interventions

California Cognitive Assessment Battery 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.

Also known as: CCAB

CCAB vs. manual test group; Health Disparities group; Older participant group; Test-Retest Reliability group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Neurobehavioral Systems, Inc.: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Neurobehavioral Systems, Inc.

Berkeley, California, 94704, United States

RECRUITING

Related Publications (16)

• 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.

  PMID: 20680884 BACKGROUND

• 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.

  PMID: 21957866 BACKGROUND

• 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.

  PMID: 26779001 BACKGROUND

• 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.

  PMID: 26357906 BACKGROUND

• 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.

  PMID: 28127280 BACKGROUND

• 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.

  PMID: 29677192 BACKGROUND

• 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.

  PMID: 26060999 BACKGROUND

• 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.

  PMID: 25859198 BACKGROUND

• 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.

  PMID: 26617505 BACKGROUND

• 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.

  PMID: 24175464 BACKGROUND

• 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.

  PMID: 23947782 BACKGROUND

• 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.

  PMID: 26635569 BACKGROUND

• 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.

  PMID: 25954175 BACKGROUND

• 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.

  PMID: 27936001 BACKGROUND

• 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.

  PMID: 27138985 BACKGROUND

• 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.

  PMID: 26042021 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Central Study Contacts

Kathleen Hall, PhD

CONTACT

510-214-3176; clinical_trial_coordinator@neurobs.com

David Woods

CONTACT

5105279231; drdlwoods@neurobs.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 16, 2021
• Study Start: May 5, 2021
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: May 22, 2025

Record last verified: 2025-05

Locations

US (1)