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.
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.
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 group | Role | What they receive |
|---|---|---|
| Experimental Treatment | Experimental | Computerized 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 Comparator | Active comparator | Commercially 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.
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.
- First posted4 Nov 2019
- Study start16 Jul 2021
- Primary completion7 Jun 2024
- Study completion7 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Posit Science Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- McGill University, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Thomas Van Vleet, PhD, Principal investigator, Posit Science CorporationMouna Attarha, PhD, Principal investigator, Posit Science Corporation
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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 39116435Attarha 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 40622012Attarha 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 40654319Pelegrino 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 40191405Attarha 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Neurological Health in Aging Via Neuroplasticity-based Computerized Exercise (INHANCE)
- ClinicalTrials.gov ID
- NCT04149457
- Acronym / sponsor ID
- INHANCE / PSC-0903-19
- Conditions
- Healthy Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Posit Science CorporationIndustry (pharma, biotech, devices)
- Collaborators
- McGill University, National Institute on Aging (NIA)
- Study start
- 16 Jul 2021 (actual)
- Primary completion
- 7 Jun 2024 (actual)
- Study completion
- 7 Jun 2024 (actual)
- First posted
- 4 Nov 2019 (actual)
- Results
- Posted 13 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Treatment | Experimental | Other: Computerized Plasticity-Based Adaptive Cognitive TrainingComputerized plasticity-based adaptive cognitive training requiring a total maximum of 70 treatment sessions, up to 7 sessions per week, 30 minutes per session. |
| Active Comparator | Active comparator | Other: Commercially available computerized trainingCommercially available computerized training requiring a total maximum of 70 treatment sessions, up to 7 sessions per week, 30 minutes per session. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized Plasticity-Based Adaptive Cognitive TrainingThirty minutes of training on computerized exercises that targets visual processing speed, memory, attention and alertness. | Other | Experimental Treatment |
| Commercially available computerized trainingThirty minutes of training on computerized, casual video games. | Other | Active Comparator |
Primary outcome
Change Mean in FEOBV SUVR (Standardized Uptake Value Ratio) Through PET Imaging in the Anterior Cingulate Cortex
Time frame: At 3 months (post-intervention)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 39116435Attarha 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.
- Background: PubMed 40622012Attarha 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.
- Background: PubMed 40654319Attarha 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.
- Background: PubMed 40191405Pelegrino 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.
- Results publication: PubMed 41084791Attarha 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.
- Two years after trial completion (on May 31, 2026), the INHANCE dataset will be made available to verified academic and industry researchers. Investigators can conduct both confirmatory and exploratory analyses using LORIS.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Van Vleet, PhD principal investigator
Posit Science Corporation
Mouna Attarha, PhD principal investigator
Posit Science Corporation
1 site in 1 country: see every site and its status.
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.