Brain Enhancement Training Towards Elders Resilience to Aging, Phase IIB

NCT05599490 | Completed DMC

• 1 other identifier: PSC-1024-22
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 2

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.

Conditions

Age-related Cognitive Decline

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Change in performance on processing speed composite score

  At 5 years and at 3 months

• Change in performance on working memory

  At 5 years and at 3 months

• Changes in performance on episodic memory

  At 5 years and at 3 months

• Change in performance on executive function

  At 5 years and at 3 months

• Change in brain function

  At 5 years and at 3 months

Other Outcomes (8)

• Change in Stress

  At 5 years and at 3 months

• Change in Self-Efficacy

  At 5 years and at 3 months

• Change in Life Satisfaction

  At 5 years and at 3 months

Study Arms (1)

Experimental Treatment

EXPERIMENTAL

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

Interventions

Computerized Plasticity-Based Adaptive Cognitive Training OTHER

Forty-two minutes of training on computerized exercises that targets processing speed, memory and attention.

Also known as: PACR-CT

Experimental Treatment

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Posit Science Corporation: lead
• University of Iowa: collaborator
• The University of Texas at Dallas: collaborator

Study Sites (2)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Texas at Dallas

Dallas, Texas, 75235, United States

Location

Study Officials

• Hyun Kyu Lee, PhD

  Posit Science Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The Investigators and Assessors will be blinded to the previous treatment assignment of participants from the Phase II study.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: October 31, 2022
• Study Start: December 14, 2023
• Primary Completion: January 28, 2026
• Study Completion: January 28, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

US (2)