Brain Enhancement Training Towards Elders Resilience to Aging, Phase IIB

Last updated: April 9, 2025
Sponsor: Posit Science Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aging

Memory Loss

Dementia

Treatment

Computerized Plasticity-Based Adaptive Cognitive Training

Clinical Study ID

NCT05599490
PSC-1024-22
  • Ages > 70
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 normalviewing distance, auditory capacity adequate to understand normal speech, and motorcapacity adequate to control a computer mouse

  • Participant must not have evidence of dementia as indicated by the MontrealCognitive Assessment (MoCA)

Exclusion

Exclusion Criteria:

  • Participant with any medical illnesses, injuries or conditions predisposing toimminent functional and/or cognitive decline

  • Participant requiring caregiver assistance in dressing/personal hygiene

  • Participant with severe visual deficits (including visual neglect, partial fieldcuts, anopias) and/or severe hearing deficit that would prevent use of thecomputerized treatment program

  • Participant with recent participation of computer-delivered cognitive trainingwithin 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 orauto-defibrillators, neural pacemaker, aneurysm clips, cochlear implant, metallicbodies in the eye or central nervous system, any form of wires or metal devices thatmay concentrate radio frequency fields)

  • Participants with active suicidal ideation with specific plan and intent orsuicide-related behaviors within 2 months of consent as measured by theColumbia-Suicide Severity Rating Scale (C-SSRS)

Study Design

Total Participants: 180
Treatment Group(s): 1
Primary Treatment: Computerized Plasticity-Based Adaptive Cognitive Training
Phase:
Study Start date:
December 14, 2023
Estimated Completion Date:
April 01, 2026

Study 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).

Connect with a study center

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • University of Texas at Dallas

    Dallas, Texas 75235
    United States

    Active - Recruiting

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