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Brain Enhancement Training Towards Elders Resilience to Aging (BETTER Aging)

Primary Purpose

Age-related Cognitive Decline

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized Plasticity-Based Adaptive Cognitive Training
Commercially available computerized training
Sponsored by
Posit Science Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-related Cognitive Decline

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participant must be 65 years of age or older
  • Participant must be a fluent English speaker
  • Participant must have adequate sensorimotor capacity to perform the program, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control a computer mouse
  • Participant must not have evidence of dementia as indicated by the Montreal Cognitive Assessment (MoCA)

Exclusion Criteria:

  • Participant with any medical illnesses, injuries or conditions predisposing to imminent functional and/or cognitive decline
  • Participant requiring caregiver assistance in dressing/personal hygiene
  • Participant with severe visual deficits (including visual neglect, partial field cuts, anopias) and/or severe hearing deficit that would prevent use of the computerized treatment program
  • Participant with recent participation of computer-delivered cognitive training within 2 years of consent
  • Participant with claustrophobia or any other contraindication to MRI scanning
  • Participant with inability to complete a 1-hour MRI
  • Pregnant women
  • Participant with any implanted devices above the waist (e.g., cardiac pacemaker or auto-defibrillators, neural pacemaker, aneurysm clips, cochlear implant, metallic bodies in the eye or central nervous system, any form of wires or metal devices that may concentrate radio frequency fields)
  • Participants with active suicidal ideation with specific plan and intent or suicide-related behaviors within 2 months of consent as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)

Sites / Locations

  • University of Iowa
  • University of Texas at Dallas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Treatment

Active Comparator

Arm Description

Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, up to 5 sessions per week, 42 minutes per session.

Commercially available computerized training requiring a total maximum of 50 treatment sessions, up to 5 sessions per week, 42 minutes per session.

Outcomes

Primary Outcome Measures

Change in performance on global cognitive composite score
Change in performance on global cognitive composite score based on the average of all normalized assessment measures.

Secondary Outcome Measures

Change in performance on processing speed composite score
Change in performance on processing speed will be measured using the composite score created by averaging the z-scores of Pattern Comparison, Letter Comparison, and Digit Symbol Coding tasks.
Change in performance on working memory
Change in performance on working memory will be measured using the composite score created by averaging the z-scores of Visual Short Term Memory and N-Back Tasks.
Changes in performance on episodic memory
Change in performance on episodic memory will be measured using the composite score created by averaging the z-scores of Selective Reminding Task and Face Name Task.
Change in performance on executive function
Change in performance on executive function will be measured using the composite score created by averaging the z-scores of Flanker Task and Task Switch (fMRI task).
Change in brain function
Change in resting state functional connectivity will be measured by resting State T2*weighted EPI-BOLD, a 10-minute task-free BOLD contrast sequence consisting of 300 volumes (TR=2000 ms/TE=30ms) at 3.4mm3 in-plane resolution and 3mm slice thickness. Participants will be instructed to keep their eyes open and maintain attention on a central gray fixation cross on a black screen.
Change in brain structure
3D T1-Weighted multi-echo MPRAGE. Morphometric analyses will be based on this MRI sequence (not accelerated because the reliability of acceleration for multi-site studies has not yet been established). We will achieve spatial resolution of 1 x 1 x 1 mm voxels.
Change in task-related brain activation
Change in functional connectivity and brain activation will be measured while performing Task Switch.
Change in functional performance
Between-group magnitude of change in sum time of all tasks in the Timed Instrumental Activities of Daily Living (TIADL). Higher scores indicate greater impairment in functional performance.
Change in Depressive Symptoms
Between-group magnitude of change in sum score using the self-report measure, Center for Epidemiologic Studies Depression Scale (CES-D). The scoring range is 0-60. Higher scores indicate the presence of more symptomatology.

Full Information

First Posted
June 21, 2017
Last Updated
October 13, 2022
Sponsor
Posit Science Corporation
Collaborators
University of Iowa, The University of Texas at Dallas, National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT03197454
Brief Title
Brain Enhancement Training Towards Elders Resilience to Aging
Acronym
BETTER Aging
Official Title
Brain Enhancement Training Towards Elders Resilience to Aging (BETTER Aging)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
July 16, 2021 (Actual)
Study Completion Date
July 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Posit Science Corporation
Collaborators
University of Iowa, The University of Texas at Dallas, National Institute on Aging (NIA)

4. Oversight

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

5. Study Description

Brief Summary
This study is a parallel arm, double-blind, randomized, controlled clinical trial to assess the efficacy of an experimental software program designed to improve cognitive functions versus a computer-based software control. Both the study and the software being investigated meet the criteria of Non-Significant Risk.
Detailed Description
The primary objective of this study is to evaluate the effects of the experimental treatment (cognitive training) further outlined in this protocol on the cognitive abilities (e.g., processing speed, attention, working memory, and executive function), brain functionality, functional status and quality of life of individuals with age-related cognitive decline as compared to a computer-based active control.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Cognitive Decline

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Treatment
Arm Type
Experimental
Arm Description
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, up to 5 sessions per week, 42 minutes per session.
Arm Title
Active Comparator
Arm Type
Active Comparator
Arm Description
Commercially available computerized training requiring a total maximum of 50 treatment sessions, up to 5 sessions per week, 42 minutes per session.
Intervention Type
Other
Intervention Name(s)
Computerized Plasticity-Based Adaptive Cognitive Training
Intervention Description
Forty-two minutes of training on computerized exercises that targets processing speed, memory and attention.
Intervention Type
Other
Intervention Name(s)
Commercially available computerized training
Intervention Description
Forty-two minutes of training on computerized, casual video games.
Primary Outcome Measure Information:
Title
Change in performance on global cognitive composite score
Description
Change in performance on global cognitive composite score based on the average of all normalized assessment measures.
Time Frame
At 3 months and at 9 months
Secondary Outcome Measure Information:
Title
Change in performance on processing speed composite score
Description
Change in performance on processing speed will be measured using the composite score created by averaging the z-scores of Pattern Comparison, Letter Comparison, and Digit Symbol Coding tasks.
Time Frame
At 3 months and at 9 months
Title
Change in performance on working memory
Description
Change in performance on working memory will be measured using the composite score created by averaging the z-scores of Visual Short Term Memory and N-Back Tasks.
Time Frame
At 3 months and at 9 months
Title
Changes in performance on episodic memory
Description
Change in performance on episodic memory will be measured using the composite score created by averaging the z-scores of Selective Reminding Task and Face Name Task.
Time Frame
At 3 months and at 9 months
Title
Change in performance on executive function
Description
Change in performance on executive function will be measured using the composite score created by averaging the z-scores of Flanker Task and Task Switch (fMRI task).
Time Frame
At 3 months and at 9 months
Title
Change in brain function
Description
Change in resting state functional connectivity will be measured by resting State T2*weighted EPI-BOLD, a 10-minute task-free BOLD contrast sequence consisting of 300 volumes (TR=2000 ms/TE=30ms) at 3.4mm3 in-plane resolution and 3mm slice thickness. Participants will be instructed to keep their eyes open and maintain attention on a central gray fixation cross on a black screen.
Time Frame
At 3 months
Title
Change in brain structure
Description
3D T1-Weighted multi-echo MPRAGE. Morphometric analyses will be based on this MRI sequence (not accelerated because the reliability of acceleration for multi-site studies has not yet been established). We will achieve spatial resolution of 1 x 1 x 1 mm voxels.
Time Frame
At 3 months
Title
Change in task-related brain activation
Description
Change in functional connectivity and brain activation will be measured while performing Task Switch.
Time Frame
At 3 months
Title
Change in functional performance
Description
Between-group magnitude of change in sum time of all tasks in the Timed Instrumental Activities of Daily Living (TIADL). Higher scores indicate greater impairment in functional performance.
Time Frame
At 3 months and at 9 months
Title
Change in Depressive Symptoms
Description
Between-group magnitude of change in sum score using the self-report measure, Center for Epidemiologic Studies Depression Scale (CES-D). The scoring range is 0-60. Higher scores indicate the presence of more symptomatology.
Time Frame
At 3 months and at 9 months
Other Pre-specified Outcome Measures:
Title
Change in Stress
Description
Between-group magnitude of change in sum score using the self-report measure, Perceived Stress Scale (PSS-10). The scoring range is 0-40. Higher scores indicate higher perceived stress.
Time Frame
At 3 months and at 9 months
Title
Change in Self-Efficacy
Description
Between-group magnitude of change in sum score using the self-report measure, Self-Efficacy Survey. The scoring range is 10-40. Lower scores indicate lower self efficacy.
Time Frame
At 3 months and at 9 months
Title
Change in Life Satisfaction
Description
Between-group magnitude of change in sum score using the self-report measure, Life Satisfaction Scale. The scoring range is 5-35. Lower scores indicate lower life satisfaction.
Time Frame
At 3 months and at 9 months
Title
Change in Physical Activity
Description
Change in total score based on weekly self-report dairy about physical activity during training period.
Time Frame
At 3 months
Title
Change in Diet
Description
Change in total score based on weekly self-report dairy about diet during training period.
Time Frame
At 3 months
Title
Change in Social Activity
Description
Change in total score based on weekly self-report dairy about social activity during training period.
Time Frame
At 3 months
Title
Change in Sleep
Description
Change in total score based on weekly self-report dairy about sleep during training period.
Time Frame
At 3 months
Title
Change in Functional Abilities
Description
Change in total score based on weekly self-report dairy about functional abilities during training period.
Time Frame
At 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Participant must be 65 years of age or older Participant must be a fluent English speaker Participant must have adequate sensorimotor capacity to perform the program, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control a computer mouse Participant must not have evidence of dementia as indicated by the Montreal Cognitive Assessment (MoCA) Exclusion Criteria: Participant with any medical illnesses, injuries or conditions predisposing to imminent functional and/or cognitive decline Participant requiring caregiver assistance in dressing/personal hygiene Participant with severe visual deficits (including visual neglect, partial field cuts, anopias) and/or severe hearing deficit that would prevent use of the computerized treatment program Participant with recent participation of computer-delivered cognitive training within 2 years of consent Participant with claustrophobia or any other contraindication to MRI scanning Participant with inability to complete a 1-hour MRI Pregnant women Participant with any implanted devices above the waist (e.g., cardiac pacemaker or auto-defibrillators, neural pacemaker, aneurysm clips, cochlear implant, metallic bodies in the eye or central nervous system, any form of wires or metal devices that may concentrate radio frequency fields) Participants with active suicidal ideation with specific plan and intent or suicide-related behaviors within 2 months of consent as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyun Kyu Lee, PhD
Organizational Affiliation
Posit Science Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Texas at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

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