Brain Enhancement Training Towards Elders Resilience to Aging, Phase IIB (BETTER Aging)

BETTER Aging Trial: Brain Enhancement Training Towards Elders Resilience to Aging, Phase IIB

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.

Study Overview

• Status: Completed
• Conditions: Age-related Cognitive Decline
• Intervention / Treatment: Other: Computerized Plasticity-Based Adaptive Cognitive Training

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).

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Texas
    • Dallas, Texas, United States, 75235
      • University of Texas at Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Treatment; Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, up to 5 sessions per week, 42 minutes per session.	Other: Computerized Plasticity-Based Adaptive Cognitive Training; Forty-two minutes of training on computerized exercises that targets processing speed, memory and attention.; Other Names: PACR-CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 5 years and at 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At 5 years and at 3 months
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.	At 5 years and at 3 months
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.	At 5 years and at 3 months
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).	At 5 years and at 3 months
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.	At 5 years and at 3 months
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.	At 5 years and at 3 months
Change in task-related brain activation	Change in functional connectivity and brain activation will be measured while performing Task Switch.	At 5 years and at 3 months
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.	At 5 years and at 3 months
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.	At 5 years and at 3 months
Blood-based Biomarker for Alzheimer's Disease	Group differences in the P-tau181, Aβ1-42/Aβ1-40 concentrations	At 5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Stress	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.	At 5 years and at 3 months
Change in Self-Efficacy	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.	At 5 years and at 3 months
Change in Life Satisfaction	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.	At 5 years and at 3 months
Change in Physical Activity	Change in total score based on weekly self-report dairy about physical activity during training period.	At 5 years and at 3 months
Change in Diet	Change in total score based on weekly self-report dairy about diet during training period.	At 5 years and at 3 months
Change in Social Activity	Change in total score based on weekly self-report dairy about social activity during training period.	At 5 years and at 3 months
Change in Sleep	Change in total score based on weekly self-report dairy about sleep during training period.	At 5 years and at 3 months
Change in Functional Abilities	Change in total score based on weekly self-report dairy about functional abilities during training period.	At 5 years and at 3 months

Collaborators and Investigators

• Sponsor: Posit Science Corporation
• Collaborators: University of Iowa; The University of Texas at Dallas
• Investigators: Principal Investigator: Hyun Kyu Lee, PhD, Posit Science Corporation

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2023
• Primary Completion (Actual): January 28, 2026
• Study Completion (Actual): January 28, 2026

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): October 31, 2022

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: PSC-1024-22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No