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Recruiting NCT04800588

Computerized Tests of Cognitive Decline in Presymptomatic Alzheimer's Disease

No phase Interventional Alzheimer Disease Cognitive Decline Aging

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: California Cognitive Assessment Battery.
Who it may be relevant to
Registry conditions: Alzheimer Disease, Cognitive Decline, Aging. Basic parameters: 18 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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.

Interventions

  • Diagnostic test 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

Primary outcome measures

  • Longitudinal normative data collection from healthy participants [Time frame: Longitudinal testing at six-month intervals]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Neurobehavioral Systems, Inc. — Berkeley

Publications

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT04800588 · 4R44AG062076

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗