Clinical trial NCT04800588: Computerized Tests of Cognitive Decline in Presymptomatic Alzheimer's Disease
Official title: Computerized Tests of Cognitive Decline in Presymptomatic Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Cognitive Decline
Aging
Keywords: Aging
Elderly
Alzheimer's disease
Cognition
Computerized
Testing
Lead sponsor: Neurobehavioral Systems, Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
First posted: 2021-03-16
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Longitudinal normative data collection from healthy participants
timeFrame: Longitudinal testing at six-month intervals
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Neurobehavioral Systems, Inc.
state: California
Study officials:
References:
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