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Computerized Tests of Cognitive Decline in Presymptomatic Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT04800588
Recruitment Status : Recruiting
First Posted : March 16, 2021
Last Update Posted : March 26, 2021
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Neurobehavioral Systems, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Cognitive Decline Aging Diagnostic Test: California Cognitive Assessment Battery Diagnostic Test: Fast Automated Cognitive Test Battery Not Applicable

Detailed Description:

In Group A, the investigators will evaluate the performance of healthy older participants (N = 500, 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. Subjects will also undergo APOE genetic testing with saliva samples.

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 younger participants (N = 400, ages 18 to 59) for three days at enrollment. A subset of these subjects (N=150) will undergo longitudinal testing at 6-month intervals for three years thereafter.

In Group D, the investigators will examine the performance of participants (N=1000, ages 18 to 89) on a 30-min computerized cognitive screening test.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Computerized Tests of Cognitive Decline in Presymptomatic Alzheimer's Disease
Estimated Study Start Date : May 1, 2021
Estimated Primary Completion Date : October 31, 2024
Estimated Study Completion Date : October 31, 2024

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Older participant group
We will evaluate the performance of healthy older participants (N = 500, 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. Subjects will undergo APOE genetic testing with saliva samples.
 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 Name: CCAB
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 Name: CCAB
Experimental: Younger participant group
We will gather normative data from younger participants (N = 400, ages 18 to 59) for three days at enrollment. A subset of these subjects (N=150) will undergo longitudinal testing at 6-month intervals for three years thereafter.
 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 Name: CCAB
Experimental: Screening test group
We will examine the performance of participants (N=1000, ages 18 to 89) on a 30-min computerized cognitive screening test. Testing may be repeated at 6-month or 1-year intervals.
 Diagnostic Test: Fast Automated Cognitive Test Battery
The Fast Automated Cognitive Test Battery (FACT-B) is a condensed selection of computerized cognitive tests drawn from the CCAB to act as a screening tool. These tests 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.
Other Name: FACTB


Outcome Measures
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Primary Outcome Measures :
  1. 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. Researchers will also obtain saliva samples of DNA from participants 60 years of age and older and analyze them for the presence of the APOE epsilon 4 variant. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Must be able to use computer mouse and touch screen.
  • Must speak English as a primary language

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04800588


Contacts
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Contact: John M Wyma-Hughes 5105279231 clinical_trial_coordinator@neurobs.com
Contact: David Woods 5105279231 drdlwoods@neurobs.com

Locations
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United States, California
Neurobehavioral Systems, Inc. Recruiting
Berkeley, California, United States, 94704
Contact: Garret Williams, BS    510-527-9231    garrett_williams@neurobs.com   
Contact: John Wyma-Hughes, JD    5105279231    clinical_trial_coordinator@neurobs.com   
Sponsors and Collaborators
Neurobehavioral Systems, Inc.
National Institutes of Health (NIH)
More Information
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Publications:

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Responsible Party: Neurobehavioral Systems, Inc.
ClinicalTrials.gov Identifier: NCT04800588    
Other Study ID Numbers: 4R44AG062076 ( U.S. NIH Grant/Contract )
First Posted: March 16, 2021    Key Record Dates
Last Update Posted: March 26, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Neurobehavioral Systems, Inc.:
Aging
Elderly
Alzheimer's disease
 Cognition
Computerized
Testing
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders