ClinicalTrials.gg
CompletedNCT05599490BETTER AgingUpdated Feb 19, 2026

Brain Enhancement Training Towards Elders Resilience to Aging, Phase IIB

An interventional study of Computerized Plasticity-Based Adaptive Cognitive Training in Age-related Cognitive Decline, sponsored by Posit Science Corporation. Completed at 2 sites in United States. Open to participants aged 70 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-19.

Sponsored by Posit Science Corporation · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
135
Allocation
Not applicable
Ages
70 Years and older
Sex
All
01

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.

Read the 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).

02

Conditions studied

  • Age-related Cognitive Decline
03

In context

Lead sponsor

Posit Science Corporation is the lead sponsor of 36 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (MoCA)

Exclusion criteria

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 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)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
135 participants (actual)

Study arms

  • 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

Interventions

  • OtherComputerized Plasticity-Based Adaptive Cognitive Training

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

    Also known as: PACR-CT

06

What researchers measure

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.

    Time frame: At 5 years and at 3 months

Secondary outcomes

  1. 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.

    Time frame: At 5 years and at 3 months

  2. 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.

    Time frame: At 5 years and at 3 months

  3. 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.

    Time frame: At 5 years and at 3 months

  4. 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).

    Time frame: At 5 years and at 3 months

  5. 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.

    Time frame: At 5 years and at 3 months

  6. 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.

    Time frame: At 5 years and at 3 months

  7. Change in task-related brain activation

    Change in functional connectivity and brain activation will be measured while performing Task Switch.

    Time frame: At 5 years and at 3 months

  8. 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.

    Time frame: At 5 years and at 3 months

  9. 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.

    Time frame: At 5 years and at 3 months

  10. Blood-based Biomarker for Alzheimer's Disease

    Group differences in the P-tau181, Aβ1-42/Aβ1-40 concentrations

    Time frame: At 5 years

Other outcomes

  1. 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.

    Time frame: At 5 years and at 3 months

  2. 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.

    Time frame: At 5 years and at 3 months

  3. 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.

    Time frame: At 5 years and at 3 months

  4. Change in Physical Activity

    Change in total score based on weekly self-report dairy about physical activity during training period.

    Time frame: At 5 years and at 3 months

  5. Change in Diet

    Change in total score based on weekly self-report dairy about diet during training period.

    Time frame: At 5 years and at 3 months

  6. Change in Social Activity

    Change in total score based on weekly self-report dairy about social activity during training period.

    Time frame: At 5 years and at 3 months

  7. Change in Sleep

    Change in total score based on weekly self-report dairy about sleep during training period.

    Time frame: At 5 years and at 3 months

  8. Change in Functional Abilities

    Change in total score based on weekly self-report dairy about functional abilities during training period.

    Time frame: At 5 years and at 3 months

07

Study locations

2 sites
  • University of Iowa
    Iowa City, Iowa 52242, United States
  • University of Texas at Dallas
    Dallas, Texas 75235, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2023 to primary completion in Jan 2026, 25 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 26, 2022
First posted
Oct 31, 2022
StartActual
Dec 14, 2023
Primary completionActual
Jan 28, 2026
CompletionActual
Jan 28, 2026
Last update
Feb 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05599490
Collaborators
University of Iowa, The University of Texas at Dallas
Responsible party
Sponsor
First posted
Oct 31, 2022
Start date
Dec 14, 2023
Primary completion
Jan 28, 2026
Completion
Jan 28, 2026
Last update
Feb 19, 2026

Study contacts

Hyun Kyu Lee, PhD
principal investigator · Posit Science Corporation

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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