Brain Enhancement Training Towards Elders Resilience to Aging, Phase IIB

NCT ID: NCT05599490

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-14
• Study Completion Date: 2026-04-01

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).

Conditions

Age-related Cognitive Decline

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Computerized Plasticity-Based Adaptive Cognitive Training

Intervention Type: OTHER

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

Interventions

Computerized Plasticity-Based Adaptive Cognitive Training

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

Intervention Type: OTHER

Other Intervention Names

PACR-CT

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)

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Iowa

OTHER

Sponsor Role: collaborator

The University of Texas at Dallas

OTHER

Sponsor Role: collaborator

Posit Science Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hyun Kyu Lee, PhD

Role: PRINCIPAL_INVESTIGATOR

Posit Science Corporation

Locations

University of Iowa

Iowa City, Iowa, United States

University of Texas at Dallas

Dallas, Texas, United States

Countries

United States

Other Identifiers

PSC-1024-22

Identifier Type: -

Identifier Source: org_study_id