AzTrials
AzTrials

Healthy AgingINHANCENCT04149457

Improving Neurological Health in Aging Via Neuroplasticity-based Computerized Exercise

A study testing Computerized Plasticity-Based Adaptive Cognitive Training and Commercially available computerized training in people with Healthy Aging, run by Posit Science Corporation at 1 site in Canada.

Completed

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

Official record
Search all trials

Trial summary

This study is a validation study to evaluate efficacy of a neuroplasticity-based, computerized cognitive training program INHANCE (Improving Neurological Health in Aging via Neuroplasticity-based Computerized Exercise) to improve neurological and neuropsychological health in older adults. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy Aging
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
93 participants
Where
1 siteCanada
Study dates
16 Jul 2021to 7 Jun 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Potential participant must be 65+ years old at the time of study screening.
  • Potential participant should achieve a score of ≥ 23 on the Montreal Cognitive Assessment (MoCA).
  • Potential participant must be likely able to compete all primary outcome measures in the judgment of the consenting study staff person.
  • Potential participant must demonstrate adequate decisional capacity, in the judgment of the consenting study staff member, to make a choice about participating in this research study.
  • Potential participant must have the visual, auditory, and motors capacity to use the computerized intervention in the judgment of the consenting study staff person.
  • Potential participant must already have, be willing to obtain, or be willing to travel to locations with WiFi connectivity to complete intervention activities.
  • Potential participant must be able to communicate in either English or French.

Who cannot join

  • Potential participant should not have an existing diagnosis of major or minor neurocognitive disorder at screening.
  • Potential 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)
  • Potential participant should not have a Geriatric Depression Scale (GDS) score of >10.
  • Potential participant should not have been treated within 5 years of the date of consent with a computer-based cognitive training program manufactured by Posit Science.
  • Potential participant should not be participating in a concurrent clinical trial (involving an investigational pharmaceutical, behavioral treatment, medical device or other) that, in the judgment of the Site Principal Investigator, could affect the outcome of this study.
  • Potential participant may not be pregnant and should not have claustrophobia or implantation with any medical devices above the waist that may concentrate radio frequency fields, or have other medical issues that may frustrate participation in MRI imaging procedures.
  • Potential participant should not have medical illnesses deemed to interfere with participation in study activities and/or unstable and/or untreated conditions that may affect cognition, including substance abuse/dependence disorders, drugs that interfere with cholinergic function, ongoing chemotherapy or other cancer treatment.
  • Potential participant who shows signs of intoxication due to current substance abuse (including alcohol and/or illegal drugs) will be excluded.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • McGill University

    Montreal, Quebec, H3A 2B4

Other trials in Canada

About this study

Official title: Improving Neurological Health in Aging Via Neuroplasticity-based Computerized Exercise (INHANCE)

This study is a validation study to evaluate efficacy of a neuroplasticity-based, computerized cognitive training program INHANCE (Improving Neurological Health in Aging via Neuroplasticity-based Computerized Exercise) to improve neurological and neuropsychological health in older adults.

Read the detailed description

The primary objective of this study is to evaluate the impact of a targeted speed and alertness training program (INHANCE) to improve cognition in healthy older adults, as evidenced by standard measures of cognition, and positive improvements in the neuromodulatory cholinergic system as measured via positron-emission tomography (PET).

The investigators will employ a double-blind, parallel-arm, placebo-controlled, randomized clinical trial design comprised of a treatment group using INHANCE, a computerized program that trains speed of processing and attention, compared to an active control group using computer games in 92 healthy older adults.

Approximately 108 participants will be consented to ensure the successful completion of 92 participants (post 20% attrition). Participants will then complete the Screening (V0) assessments to determine eligibility. Following inclusion, participants will complete the Baseline (V1) assessments, PET imaging and structural MRI scan; participants will then be randomized into either the INHANCE training or Computer Games, and will engage in approximately 35 hours of program use for the 10-week intervention period. Approximately halfway through the intervention period (~5 weeks), participants will complete Interim (V2) assessments to be compared to the Post-Intervention assessments. Following the 10-week intervention, participants will complete a Post-Intervention (V3) assessment and PET imaging to evaluate changes in cognitive function. Participants will then stop using their assigned program for 3 months and return for a Follow-up (V4) end-of-study assessment to evaluate the endurance of changes in cognitive function in the absence of further program use.

Conditions
Healthy Aging
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

    Thirty minutes of training on computerized exercises that targets visual processing speed, memory, attention and alertness.

  • Commercially available computerized trainingOther

    Thirty minutes of training on computerized, casual video games.

Study groups in NCT04149457
Study groupRoleWhat they receive
Experimental TreatmentExperimentalComputerized plasticity-based adaptive cognitive training requiring a total maximum of 70 treatment sessions, up to 7 sessions per week, 30 minutes per session.
Receives: Other: Computerized Plasticity-Based Adaptive Cognitive Training
Active ComparatorActive comparatorCommercially available computerized training requiring a total maximum of 70 treatment sessions, up to 7 sessions per week, 30 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 Mean in FEOBV SUVR (Standardized Uptake Value Ratio) Through PET Imaging in the Anterior Cingulate Cortex

    Change from baseline and 3 months (post-intervention) for the 18F-fluoroethoxybenzovesamicol (FEOBV) standardized uptake value ratio (SUVR) in the Anterior Cingulate Cortex as measured through Positron Emission Tomography (PET) ligand imaging. Higher score is better.

    Measured: At 3 months (post-intervention)

Timeline

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

  1. First posted4 Nov 2019
  2. Study start16 Jul 2021
  3. Primary completion7 Jun 2024
  4. Study completion7 Jun 2024

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
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04149457
Sponsor's protocol ID
PSC-0903-19
Other IDs
5R44AG039965-06
Acronym
INHANCE
Status last verified
Jun 2026
First submitted
28 Oct 2019
Last updated
13 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Attarha M, de Figueiredo Pelegrino AC, Toussaint PJ, Grant SJ, Van Vleet T, de Villers-Sidani E. Improving Neurological Health in Aging Via Neuroplasticity-Based Computerized Exercise: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Aug 8;13:e59705. doi: 10.2196/59705.

    PubMed 39116435
  • Attarha M, De Figueiredo Pelegrino A, Ouellet L, Toussaint PJ, Grant SJ, Van Vleet T, de Villers-Sidani E. Association of a Brief Computerized Cognitive Assessment With Cholinergic Neurotransmission: Assessment Validation Study. JMIR Form Res. 2025 Jul 7;9:e68374. doi: 10.2196/68374.

    PubMed 40622012
  • Attarha M, Carolina de Figueiredo Pelegrino A, Ouellet L, Grant SJ, de Villers-Sidani E, Van Vleet T. Bringing Executive Function Testing Online: Assessment Validation Study. JMIR Form Res. 2025 Jul 14;9:e75687. doi: 10.2196/75687.

    PubMed 40654319
  • Pelegrino AF, Attarha M, Toussaint PJ, Ouellet L, Grant SJ, Van Vleet T, de Villers-Sidani E. Cholinergic neurotransmission in the anterior cingulate cortex is associated with cognitive performance in healthy older adults: Baseline characteristics of the Improving Neurological Health in Aging via Neuroplasticity-based Computerized Exercise (INHANCE) trial. Neuroimage Rep. 2025 Mar;5(1):100234. doi: 10.1016/j.ynirp.2025.100234. Epub 2025 Jan 29.

    PubMed 40191405
  • Attarha M, de Figueiredo Pelegrino A, Ouellet L, Toussaint PJ, Grant SJ, Van Vleet T, de Villers-Sidani E. Effects of Computerized Cognitive Training on Vesicular Acetylcholine Transporter Levels using [18F]Fluoroethoxybenzovesamicol Positron Emission Tomography in Healthy Older Adults: Results from the Improving Neurological Health in Aging via Neuroplasticity-based Computerized Exercise (INHANCE) Randomized Clinical Trial. JMIR Serious Games. 2025 Oct 13;13:e75161. doi: 10.2196/75161.

    PubMed 41084791

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 Healthy Aging, run by Posit Science Corporation at 1 site in Canada.

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 7 inclusion and 8 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 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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?

Yes. Results are posted in the registry (first posted 13 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Mean in FEOBV SUVR (Standardized Uptake Value Ratio) Through PET Imaging in the Anterior Cingulate Cortex (time frame: At 3 months (post-intervention)). 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 NCT04149457, which also lists 5 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 13 Jul 2026; AzTrials last refreshed its copy on 31 Oct 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in