Computerized Tests of Cognitive Decline in Presymptomatic Alzheimer's Disease

March 22, 2023 updated by: Neurobehavioral Systems, Inc.
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Diagnostic test: California 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.
Other Names:
  • CCAB
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.
Diagnostic test: California 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.
Other Names:
  • CCAB
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.
Diagnostic test: California 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.
Other Names:
  • CCAB
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.
Diagnostic test: California 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.
Other Names:
  • CCAB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Longitudinal normative data collection from healthy participants
Time Frame: 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.
Longitudinal testing at six-month intervals

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurobehavioral Systems, Inc.

Collaborators

National Institutes of Health (NIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2021

Primary Completion (Anticipated)

March 31, 2027

Study Completion (Anticipated)

March 31, 2027

Study Registration Dates

First Submitted

March 10, 2021

First Submitted That Met QC Criteria

March 12, 2021

First Posted (Actual)

March 16, 2021

Study Record Updates

Last Update Posted (Actual)

March 24, 2023

Last Update Submitted That Met QC Criteria

March 22, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4R44AG062076 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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