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Computerized Tests of Cognitive Decline in Presymptomatic Alzheimer's Disease

Primary Purpose

Alzheimer Disease, Cognitive Decline, Aging

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
California Cognitive Assessment Battery
Sponsored by
Neurobehavioral Systems, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer Disease focused on measuring Aging, Elderly, Alzheimer's disease, Cognition, Computerized, Testing

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Neurobehavioral Systems, Inc.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Older participant group

CCAB vs. manual test group

Test-Retest Reliability group

Health Disparities group

Arm 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.

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

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.

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.

Outcomes

Primary Outcome Measures

Longitudinal normative data collection from healthy participants
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.

Secondary Outcome Measures

Full Information

First Posted
March 10, 2021
Last Updated
March 22, 2023
Sponsor
Neurobehavioral Systems, Inc.
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT04800588
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2021 (Actual)
Primary Completion Date
March 31, 2027 (Anticipated)
Study Completion Date
March 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neurobehavioral Systems, Inc.
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Cognitive Decline, Aging
Keywords
Aging, Elderly, Alzheimer's disease, Cognition, Computerized, Testing

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Older participant group
Arm Type
Experimental
Arm 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.
Arm Title
CCAB vs. manual test group
Arm Type
Experimental
Arm Description
We will compare the performance of normal participants (N = 100, age range 18 to 89) on computerized and manually administered cognitive tasks.
Arm Title
Test-Retest Reliability group
Arm Type
Experimental
Arm 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.
Arm Title
Health Disparities group
Arm Type
Experimental
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
California Cognitive Assessment Battery
Other Intervention Name(s)
CCAB
Intervention Description
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.
Primary Outcome Measure Information:
Title
Longitudinal normative data collection from healthy participants
Description
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.
Time Frame
Longitudinal testing at six-month intervals

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Garrett Williams
Phone
7735959493
Email
garrett_williams@neurobs.com
First Name & Middle Initial & Last Name or Official Title & Degree
David Woods
Phone
5105279231
Email
drdlwoods@neurobs.com
Facility Information:
Facility Name
Neurobehavioral Systems, Inc.
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Garrett Williams, BS
Phone
773-595-9493
Email
garrett_williams@neurobs.com
First Name & Middle Initial & Last Name & Degree
Coordinator
Email
clinical_trial_coordinator@neurobs.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
20680884
Citation
Woods DL, Kishiyamaa MM, Lund EW, Herron TJ, Edwards B, Poliva O, Hink RF, Reed B. Improving digit span assessment of short-term verbal memory. J Clin Exp Neuropsychol. 2011 Jan;33(1):101-11. doi: 10.1080/13803395.2010.493149.
Results Reference
background
PubMed Identifier
21957866
Citation
Woods DL, Herron TJ, Yund EW, Hink RF, Kishiyama MM, Reed B. Computerized analysis of error patterns in digit span recall. J Clin Exp Neuropsychol. 2011 Aug;33(7):721-34. doi: 10.1080/13803395.2010.550602.
Results Reference
background
PubMed Identifier
26779001
Citation
Woods DL, Wyma JM, Herron TJ, Yund EW. The Effects of Repeat Testing, Malingering, and Traumatic Brain Injury on Computerized Measures of Visuospatial Memory Span. Front Hum Neurosci. 2016 Jan 5;9:690. doi: 10.3389/fnhum.2015.00690. eCollection 2015.
Results Reference
background
PubMed Identifier
26357906
Citation
Woods DL, Wyma JM, Herron TJ, Yund EW. An improved spatial span test of visuospatial memory. Memory. 2016 Sep;24(8):1142-55. doi: 10.1080/09658211.2015.1076849. Epub 2015 Sep 11.
Results Reference
background
PubMed Identifier
28127280
Citation
Woods DL, Wyma JM, Herron TJ, Yund EW. The Bay Area Verbal Learning Test (BAVLT): Normative Data and the Effects of Repeated Testing, Simulated Malingering, and Traumatic Brain Injury. Front Hum Neurosci. 2017 Jan 12;10:654. doi: 10.3389/fnhum.2016.00654. eCollection 2016.
Results Reference
background
PubMed Identifier
29677192
Citation
Woods DL, Wyma JM, Herron TJ, Yund EW, Reed B. The Dyad-Adaptive Paced Auditory Serial Addition Test (DA-PASAT): Normative data and the effects of repeated testing, simulated malingering, and traumatic brain injury. PLoS One. 2018 Apr 20;13(4):e0178148. doi: 10.1371/journal.pone.0178148. eCollection 2018.
Results Reference
background
PubMed Identifier
26060999
Citation
Woods DL, Wyma JM, Herron TJ, Yund EW. The Effects of Aging, Malingering, and Traumatic Brain Injury on Computerized Trail-Making Test Performance. PLoS One. 2015 Jun 10;10(6):e0124345. doi: 10.1371/journal.pone.0124345. eCollection 2015.
Results Reference
background
PubMed Identifier
25859198
Citation
Woods DL, Wyma JM, Yund EW, Herron TJ, Reed B. Factors influencing the latency of simple reaction time. Front Hum Neurosci. 2015 Mar 26;9:131. doi: 10.3389/fnhum.2015.00131. eCollection 2015.
Results Reference
background
PubMed Identifier
26617505
Citation
Woods DL, Wyma JM, Yund EW, Herron TJ. The Effects of Repeated Testing, Simulated Malingering, and Traumatic Brain Injury on High-Precision Measures of Simple Visual Reaction Time. Front Hum Neurosci. 2015 Nov 9;9:540. doi: 10.3389/fnhum.2015.00540. eCollection 2015.
Results Reference
background
PubMed Identifier
24175464
Citation
Hubel KA, Reed B, Yund EW, Herron TJ, Woods DL. Computerized measures of finger tapping: effects of hand dominance, age, and sex. Percept Mot Skills. 2013 Jun;116(3):929-52. doi: 10.2466/25.29.PMS.116.3.929-952.
Results Reference
background
PubMed Identifier
23947782
Citation
Hubel KA, Yund EW, Herron TJ, Woods DL. Computerized measures of finger tapping: reliability, malingering and traumatic brain injury. J Clin Exp Neuropsychol. 2013;35(7):745-58. doi: 10.1080/13803395.2013.824070. Epub 2013 Aug 15.
Results Reference
background
PubMed Identifier
26635569
Citation
Woods DL, Wyma JM, Yund EW, Herron TJ. The Effects of Repeated Testing, Simulated Malingering, and Traumatic Brain Injury on Visual Choice Reaction Time. Front Hum Neurosci. 2015 Nov 24;9:595. doi: 10.3389/fnhum.2015.00595. eCollection 2015.
Results Reference
background
PubMed Identifier
25954175
Citation
Woods DL, Wyma JM, Yund EW, Herron TJ, Reed B. Age-related slowing of response selection and production in a visual choice reaction time task. Front Hum Neurosci. 2015 Apr 23;9:193. doi: 10.3389/fnhum.2015.00193. eCollection 2015. Erratum In: Front Hum Neurosci. 2015;9:350.
Results Reference
background
PubMed Identifier
27936001
Citation
Woods DL, Wyma JM, Herron TJ, Yund EW. Computerized Analysis of Verbal Fluency: Normative Data and the Effects of Repeated Testing, Simulated Malingering, and Traumatic Brain Injury. PLoS One. 2016 Dec 9;11(12):e0166439. doi: 10.1371/journal.pone.0166439. eCollection 2016.
Results Reference
background
PubMed Identifier
27138985
Citation
Woods DL, Wyma JM, Herron TJ, Yund EW. A Computerized Test of Design Fluency. PLoS One. 2016 May 3;11(5):e0153952. doi: 10.1371/journal.pone.0153952. eCollection 2016. Erratum In: PLoS One. 2016;11(7):e0158933.
Results Reference
background
PubMed Identifier
26042021
Citation
Woods DL, Yund EW, Wyma JM, Ruff R, Herron TJ. Measuring executive function in control subjects and TBI patients with question completion time (QCT). Front Hum Neurosci. 2015 May 19;9:288. doi: 10.3389/fnhum.2015.00288. eCollection 2015.
Results Reference
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Computerized Tests of Cognitive Decline in Presymptomatic Alzheimer's Disease

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