Back to resultsBrain Enhancement Training Towards Elders Resilience to Aging, Phase IIB (BETTER Aging)
Primary Purpose
Age-related Cognitive Decline
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized Plasticity-Based Adaptive Cognitive Training
Sponsored by
About this trial
This is an interventional treatment trial for Age-related Cognitive Decline
Eligibility Criteria
Inclusion Criteria: Participant must be 70 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 Type
Experimental
Arm Label
Experimental Treatment
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.
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.
Blood-based Biomarker for Alzheimer's Disease
Group differences in the P-tau181, Aβ1-42/Aβ1-40 concentrations
Full Information
NCT ID
NCT05599490
First Posted
October 26, 2022
Last Updated
May 2, 2023
Sponsor
Posit Science Corporation
Collaborators
University of Iowa, The University of Texas at Dallas
1. Study Identification
Unique Protocol Identification Number
NCT05599490
Brief Title
Brain Enhancement Training Towards Elders Resilience to Aging, Phase IIB
Acronym
BETTER Aging
Official Title
BETTER Aging Trial: Brain Enhancement Training Towards Elders Resilience to Aging, Phase IIB
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
April 1, 2026 (Anticipated)
Study Completion Date
April 1, 2026 (Anticipated)
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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims to examine the longer-term benefits of a novel, neuroplasticity-based, computerized and web-deliverable training program (PACR-CT) five years from the initial 10 weeks of training from our Phase II study - Protocol #: PSC-0605-17 (Aim 1) and test the interactive effect of previous training and 10 weeks of booster training (Aim 2). Both the study and the software being investigated meet the criteria of Non-Significant Risk.
Detailed Description
This study will employ a single arm, open label design with use of the PACR-CT with all participants who completed the Phase II study, as well as approximately 60 new participants (with a goal of 40 completers) who are age-matched and untrained older adults. After consent, only the new, untrained participants will complete the screening visit. Then all participants will perform the pre-training visit (cognitive and functional assessments, MRI/fMRI and blood draw), followed by 10 weeks of training, and then followed by post-training visit (cognitive and functional assessments and MRI/fMRI).
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
Single Group Assignment
Masking
None (Open Label)
Masking Description
The Investigators and Assessors will be blinded to the previous treatment assignment of participants from the Phase II study.
Allocation
N/A
Enrollment
180 (Anticipated)
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.
Intervention Type
Other
Intervention Name(s)
Computerized Plasticity-Based Adaptive Cognitive Training
Other Intervention Name(s)
PACR-CT
Intervention Description
Forty-two minutes of training on computerized exercises that targets processing speed, memory and attention.
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 5 years and at 3 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 5 years and at 3 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 5 years and at 3 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 5 years and at 3 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 5 years and at 3 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 5 years and 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 5 years and 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 5 years and 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 5 years and at 3 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 5 years and at 3 months
Title
Blood-based Biomarker for Alzheimer's Disease
Description
Group differences in the P-tau181, Aβ1-42/Aβ1-40 concentrations
Time Frame
At 5 years
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 5 years and at 3 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 5 years and at 3 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 5 years and at 3 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 5 years and 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 5 years and 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 5 years and 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 5 years and 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 5 years and at 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participant must be 70 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah-Jane Grant, MA
Phone
415-539-3130
Email
sarah-jane.grant@positscience.com
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 Contact:
First Name & Middle Initial & Last Name & Degree
Sarah-Jane Grant
Email
sarah-jane.grant@positscience.com
First Name & Middle Initial & Last Name & Degree
Michelle Voss, PhD
Facility Name
University of Texas at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah-Jane Grant
Email
sarah-jane.grant@positscience.com
First Name & Middle Initial & Last Name & Degree
Chandramallika Basak, PhD
12. IPD Sharing Statement
Learn more about this trial
Brain Enhancement Training Towards Elders Resilience to Aging, Phase IIB
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