Computerized Tests of Cognitive Decline in Presymptomatic Alzheimer's Disease

Part of paid clinical trials in Berkeley, California.

Sponsor
Neurobehavioral Systems, Inc.
Study ID
NCT04800588
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Accepted

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.

Study Details

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.

Key Dates

Start date
May 5, 2021
Status verified
May 2025
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
2,000 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.
  • Experimental: 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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Neurobehavioral Systems, Inc.BerkeleyCalifornia94704
Kathleen Hall, PhD
510-214-3176
Isabella Coordinator

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