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Computerized Tests of Cognitive Decline in Presymptomatic Alzheimer's Disease

Computerized Tests of Cognitive Decline in Presymptomatic Alzheimer's Disease

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04800588
Enrollment
2000
Registered
2021-03-16
Start date
2021-05-05
Completion date
2027-03-31
Last updated
2025-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Alzheimer Disease, Cognitive Decline

Keywords

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

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.

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_TESTCalifornia 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.

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
Neurobehavioral Systems, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Longitudinal normative data collection from healthy participantsLongitudinal testing at six-month intervalsMultiple 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.

Countries

United States

Contacts

Primary ContactKathleen Hall, PhD
clinical_trial_coordinator@neurobs.com510-214-3176
Backup ContactDavid Woods
drdlwoods@neurobs.com5105279231

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026