Computerized Tests of Cognitive Decline in Presymptomatic Alzheimer's Disease

Neurobehavioral Systems

Status: Enrolling

Conditions: Aging; Alzheimer Disease; Cognitive Decline

Treatments: Diagnostic Test: California Cognitive Assessment Battery

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT04800588

4R44AG062076

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,000 participants in 4 patient groups

Older participant group

Experimental group

Description:

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.

Treatment:

Diagnostic Test: California Cognitive Assessment Battery

CCAB vs. manual test group

Experimental group

Description:

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

Treatment:

Diagnostic Test: California Cognitive Assessment Battery

Test-Retest Reliability group

Experimental group

Description:

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.

Treatment:

Diagnostic Test: California Cognitive Assessment Battery

Health Disparities group

Experimental group

Description:

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.

Treatment:

Diagnostic Test: California Cognitive Assessment Battery