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Age-related Cognitive DeclineBETTER AgingNCT03197454

Brain Enhancement Training Towards Elders Resilience to Aging

A study testing Computerized Plasticity-Based Adaptive Cognitive Training and Commercially available computerized training in people with Age-related Cognitive Decline, run by Posit Science Corporation at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is a parallel arm, double-blind, randomized, controlled clinical trial to assess the efficacy of an experimental software program designed to improve cognitive functions versus a computer-based software control. Both the study and the software being investigated meet the criteria of Non-Significant Risk. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Age-related Cognitive Decline
What is being tested?
Computerized Plasticity-Based Adaptive Cognitive Training and Commercially available computerized training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
147 participants
Where
2 sitesUnited States
Study dates
1 Jun 2018to 16 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Participant must be 65 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)

Who cannot join

  • 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
Show all 9Show fewer
  • 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)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Texas at Dallas

    Dallas, Texas, 75235

  • University of Iowa

    Iowa City, Iowa, 52242

Other trials in United States

About this study

Official title: Brain Enhancement Training Towards Elders Resilience to Aging (BETTER Aging)

This study is a parallel arm, double-blind, randomized, controlled clinical trial to assess the efficacy of an experimental software program designed to improve cognitive functions versus a computer-based software control. Both the study and the software being investigated meet the criteria of Non-Significant Risk.

Read the detailed description

The primary objective of this study is to evaluate the effects of the experimental treatment (cognitive training) further outlined in this protocol on the cognitive abilities (e.g., processing speed, attention, working memory, and executive function), brain functionality, functional status and quality of life of individuals with age-related cognitive decline as compared to a computer-based active control.

Being tested
Computerized Plasticity-Based Adaptive Cognitive Training, Commercially available computerized training

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Computerized Plasticity-Based Adaptive Cognitive TrainingOther

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

  • Commercially available computerized trainingOther

    Forty-two minutes of training on computerized, casual video games.

Study groups in NCT03197454
Study groupRoleWhat they receive
Experimental TreatmentExperimentalComputerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, up to 5 sessions per week, 42 minutes per session.
Receives: Other: Computerized Plasticity-Based Adaptive Cognitive Training
Active ComparatorActive comparatorCommercially available computerized training requiring a total maximum of 50 treatment sessions, up to 5 sessions per week, 42 minutes per session.
Receives: Other: Commercially available computerized training

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At 3 months and at 9 months

Secondary outcomes (8)

  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.

    Measured: At 3 months and at 9 months

  2. Change in performance on memory

    Change in performance on memory will be measured using the composite score created by averaging the z-scores of Selective Reminding Task, Face Name Task, and Visual Short Term Memory tasks.

    Measured: At 3 months and at 9 months

  3. 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, N-Back Task and Task Switch (fMRI task).

    Measured: At 3 months and at 9 months

  4. 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.

    Measured: At 3 months

  5. 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.

    Measured: At 3 months

  6. Change in task-related brain activation

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

    Measured: At 3 months

  7. 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.

    Measured: At 3 months and at 9 months

  8. 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.

    Measured: At 3 months and at 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2017
  2. Study start1 Jun 2018
  3. Primary completion16 Jul 2021
  4. Study completion16 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
147 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03197454
Sponsor's protocol ID
PSC-0605-17
Acronym
BETTER Aging
Status last verified
Oct 2023
First submitted
21 Jun 2017
Last updated
31 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Skolasinska P, Qin S, Voss M, Lee HK, Basak C. Brain activations elicited during task-switching generalize beyond the task: A partial least squares correlation approach to combine fMRI signals and cognition. Hum Brain Mapp. 2024 Aug 1;45(11):e26804. doi: 10.1002/hbm.26804.

    PubMed 39126346

  • Lee HK, Basak C, Grant SJ, Ray NR, Skolasinska PA, Oehler C, Qin S, Sun A, Smith ET, Sherard GH, Rivera-Dompenciel A, Merzenich M, Voss MW. The Effects of Computerized Cognitive Training in Older Adults' Cognitive Performance and Biomarkers of Structural Brain Aging. J Gerontol B Psychol Sci Soc Sci. 2024 Jul 1;79(7):gbae075. doi: 10.1093/geronb/gbae075.

    PubMed 38686621

Questions about this trial

What is this clinical trial studying?

A study testing Computerized Plasticity-Based Adaptive Cognitive Training and Commercially available computerized training in people with Age-related Cognitive Decline, run by Posit Science Corporation at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in performance on global cognitive composite score (time frame: At 3 months and at 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03197454, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023; AzTrials last refreshed its copy on 29 Oct 2026.

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