Clinical trial NCT05599490: Brain Enhancement Training Towards Elders Resilience to Aging, Phase IIB
Official title: BETTER Aging Trial: Brain Enhancement Training Towards Elders Resilience to Aging, Phase IIB
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Age-related Cognitive Decline
Lead sponsor: Posit Science Corporation
Sponsor class: INDUSTRY
Collaborators: name: University of Iowa
name: The University of Texas at Dallas
First posted: 2022-10-31
Enrollment: 180
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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)

Primary outcomes:
measure: Change in performance on global cognitive composite score
timeFrame: At 5 years and at 3 months
Secondary outcomes:
measure: Change in performance on processing speed composite score
timeFrame: At 5 years and at 3 months
measure: Change in performance on working memory
timeFrame: At 5 years and at 3 months
measure: Changes in performance on episodic memory
timeFrame: At 5 years and at 3 months
measure: Change in performance on executive function
timeFrame: At 5 years and at 3 months
measure: Change in brain function
timeFrame: At 5 years and at 3 months
measure: Change in brain structure
timeFrame: At 5 years and at 3 months
measure: Change in task-related brain activation
timeFrame: At 5 years and at 3 months
measure: Change in functional performance
timeFrame: At 5 years and at 3 months
measure: Change in Depressive Symptoms
timeFrame: At 5 years and at 3 months
measure: Blood-based Biomarker for Alzheimer's Disease
timeFrame: At 5 years
Other outcomes:
measure: Change in Stress
timeFrame: At 5 years and at 3 months
measure: Change in Self-Efficacy
timeFrame: At 5 years and at 3 months
measure: Change in Life Satisfaction
timeFrame: At 5 years and at 3 months
measure: Change in Physical Activity
timeFrame: At 5 years and at 3 months
measure: Change in Diet
timeFrame: At 5 years and at 3 months
measure: Change in Social Activity
timeFrame: At 5 years and at 3 months
measure: Change in Sleep
timeFrame: At 5 years and at 3 months
measure: Change in Functional Abilities
timeFrame: At 5 years and at 3 months
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Dallas
country: United States
facility: University of Texas at Dallas
state: Texas
Study officials:
affiliation: Posit Science Corporation
name: Hyun Kyu Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References: