Computerized Tests of Cognitive Decline in Presymptomatic Alzheimer's Disease

Not Applicable

Recruiting

• Conditions: Aging; Alzheimer Disease; Cognitive Decline
• Interventions: Diagnostic Test: California Cognitive Assessment Battery

• Registration Number: NCT04800588
• Lead Sponsor: Neurobehavioral Systems, Inc.

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.

Study Timeline

• Study First Submitted: 2021-03-10
• Study First Submitted QC: 2021-03-12
• Study First Posted: 2021-03-16
• Study Start: 2021-05-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22
• Primary Completion: 2027-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CCAB vs. manual test group	California Cognitive Assessment Battery	We will compare the performance of normal participants (N = 100, age range 18 to 89) on computerized and manually administered cognitive tasks.
Older participant group	California Cognitive Assessment Battery	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.
Test-Retest Reliability group	California Cognitive Assessment Battery	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.
Health Disparities group	California Cognitive Assessment Battery	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 Measures

Name	Time	Method
Longitudinal normative data collection from healthy participants	Longitudinal testing at six-month intervals	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.

Trial Locations

Locations (1)

Neurobehavioral Systems, Inc.; 🇺🇸 Berkeley, California, United States