Mild Cognitive ImpairmentINHANCE-MCINCT07243600
Improving Neurological Health With Acetylcholine Via Neuroplasticity-based Computerized Exercise in Mild Cognitive Impairment
A study testing Computerized speed-based cognitive training and Computerized executive function cognitive training in people with Mild Cognitive Impairment, run by Posit Science Corporation at 1 site in Canada.
Trial summary
This study is a validation study to evaluate efficacy of two neuroplasticity-based, computerized cognitive training programs to improve neurological and neuropsychological health in older adults with mild cognitive impairment (MCI). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Computerized speed-based cognitive training and Computerized executive function cognitive training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteCanada
- Study dates
- 25 Sep 2026to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Older adult
Who may be able to join
- Potential participant must be 65 years or older at the time of study screening.
- Potential participant must have MCI as defined by:
- Total score between 18-26 inclusive on the Montreal Cognitive Assessment (MoCA)
- Cognitive concern by participant, informant, or clinician and evidence of preserved functional abilities as defined as a Clinical Dementia Rating (CDR) of 0.5 with a memory score of 0.5 or 1.
- Potential participant must have a study partner/informant defined as any acquaintance (e.g., family member, friend, neighbor, clinician) who has regular (at least monthly) interactions (in person or remote) with the participant.
- If potential participant reports use of medications typically prescribed for dementia such as, but not limited to, Namenda, Memantine, Namzaric, Donepezil, Aricept, Rivastigmine, Exelon, Razadyne, Galantamine, Reminyl, Aducanumab, Leqembi or Lecanemab, Donanemab, the dose must be stable for at least 12 weeks prior to study enrollment.
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- Potential participant must demonstrate adequate decisional capacity, in the judgment of the investigator, and capable of to making an informed decision regarding their participation in this research study.
- Potential participant must be likely able to complete all study activities and outcome measures in the judgment of the investigator.
- Potential participant must have the visual, auditory, and motors capacity to use the computerized intervention in the judgment of the investigator.
- Potential participant must be able to communicate in either English or French.
Who cannot join
- Potential participant has an existing diagnosis of major neurocognitive disorder at screening (DSM-IV).
- Potential participant who answered 'yes' to question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the C-SSRS or 'yes' to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act or behavior) on the C-SSRS "Suicidal Behavior" if the ideation or behavior occurred within 2 months from Participant's date of consent (as recommended by the FDA for treatment trials.)
- Potential participant scores >10 on the Geriatric Depression Scale - Short Form (GDS-SF).
- Potential participant has previously completed 10 or more hours of the computerized cognitive intervention program manufactured by Posit Science.
- Potential participant is participating in a concurrent clinical trial (involving an investigational pharmaceutical, behavioral treatment, medical device or other) that, in the judgment of the investigator, could affect the outcome of this study.
- Potential participant is pregnant or breastfeeding.
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- Potential participant has 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/PET imaging procedures.
- Potential participant has a history of large vessel stroke with significant residual motor or cognitive impairment.
- Potential participant has a history of moderate to severe traumatic brain injury with residual cognitive symptoms.
- Potential participant has a history of brain tumor.
- Potential participant has a congestive heart failure diagnosis.
- Potential participant has a primary diagnosis of idiopathic Parkinson's disease.
- Potential participant has multiple sclerosis or Amyotrophic lateral sclerosis diagnosis.
- Potential participant has evidence of a non-neurodegenerative neurological disorder that would interfere with the ability to carry out study activities.
- Potential participant has has evidence of any other unstable medical conditions that would interfere with the ability to carry out study activities or cause fluctuations in cognition (for example, but not limited to, unstable diabetes, chronic obstructive pulmonary disorder dependent on oxygen).
- Potential participant has any other clinically significant or unstable medical condition (for example, but not limited to, ongoing alcohol dependency or drug abuse, schizophrenia, psychosis) that in the investigator's opinion would interfere with the ability to carry out study activities.
- Potential participant is undergoing or plans to undergo surgery requiring anesthesia, chemotherapy, or radiation treatment in the six months following screening (can be rescreened and enrolled later).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Montreal Neurological Institute-Hospital
Montreal, Quebec, H3A 2B4
Celia Sciandra, (514)-398-5500, Neurocog-cru.neuro@mcgill.ca
Ting Ting Liu, (514)-398-5500, Neurocog-cru.neuro@mcgill.ca
About this study
Official title: Improving Neurological Health With Acetylcholine Via Neuroplasticity-based Computerized Exercise in Mild Cognitive Impairment (INHANCE-MCI)
This study is a validation study to evaluate efficacy of two neuroplasticity-based, computerized cognitive training programs to improve neurological and neuropsychological health in older adults with mild cognitive impairment (MCI).
Read the detailed description
The primary objective of this study is to evaluate will evaluate the impact of speed training to change cholinergic signaling, cognitive performance, and functional abilities in patients with MCI, as evidenced by [18F]fluoroethoxybenzovesamicol (FEOBV) positron-emission tomography (PET) and standard measures of cognition and function.
The investigators will employ a prospective, double-blind, parallel-arm, active-controlled, randomized clinical trial in patients with clinically-defined mild cognitive impairment aged 65 and above with a baseline MoCA of 18-26 inclusive.
Approximately 84 participants will be consented to ensure the successful completion of at least 70 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 speed-based brain training or an active control of visual non-speeded computerized games and will engage in approximately 35 hours of program use for the 10-week Intervention Period. Following the 10-week intervention, participants will complete a Post-Intervention (V2) 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 (V3) end-of-study assessment and PET imaging to evaluate the endurance of changes in cognition, function, and behavior in the absence of further program use.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Computerized speed-based cognitive training, Computerized executive function cognitive training
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized speed-based cognitive trainingOther
Thirty minutes of training on computerized exercises that targets visual processing speed, memory, attention and alertness.
Computerized executive function cognitive trainingOther
Thirty minutes of training on computerized exercises that target executive function.
| Study group | Role | What they receive |
|---|---|---|
| Speed Training | Experimental | Computerized speed-based cognitive training requiring a total maximum of 70 treatment sessions, up to 7 sessions per week, 30 minutes per session. Receives: Other: Computerized speed-based cognitive training |
| Executive Function Training | Active comparator | Computerized executive function cognitive training requiring a total maximum of 70 treatment sessions, up to 7 sessions per week, 30 minutes per session. Receives: Other: Computerized executive function cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Global cholinergic signaling using [18F]fluoroethoxybenzovesamicol (FEOBV) positron-emission tomography (PET)
FEOBV standard uptake value ratios (SUVR) in the global cortex ROI. 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 posted24 Nov 2025
- Study start25 Sep 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Posit Science Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- McGill University
- Responsible party
- Sponsor
- Investigators
- Mouna Attarha, PhD, Principal investigator, Posit Science Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243600
- Sponsor's protocol ID
- PSC-0703-25
- Acronym
- INHANCE-MCI
- Status last verified
- Sep 2026
- First submitted
- 14 Nov 2025
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Neurological Health With Acetylcholine Via Neuroplasticity-based Computerized Exercise in Mild Cognitive Impairment (INHANCE-MCI)
- ClinicalTrials.gov ID
- NCT07243600
- Acronym / sponsor ID
- INHANCE-MCI / PSC-0703-25
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Posit Science CorporationIndustry (pharma, biotech, devices)
- Collaborators
- McGill University
- Study start
- 25 Sep 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
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 two neuroplasticity-based, computerized cognitive training programs to improve neurological and neuropsychological health in older adults with mild cognitive impairment (MCI).
Detailed description
The primary objective of this study is to evaluate will evaluate the impact of speed training to change cholinergic signaling, cognitive performance, and functional abilities in patients with MCI, as evidenced by [18F]fluoroethoxybenzovesamicol (FEOBV) positron-emission tomography (PET) and standard measures of cognition and function.
The investigators will employ a prospective, double-blind, parallel-arm, active-controlled, randomized clinical trial in patients with clinically-defined mild cognitive impairment aged 65 and above with a baseline MoCA of 18-26 inclusive.
Approximately 84 participants will be consented to ensure the successful completion of at least 70 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 speed-based brain training or an active control of visual non-speeded computerized games and will engage in approximately 35 hours of program use for the 10-week Intervention Period. Following the 10-week intervention, participants will complete a Post-Intervention (V2) 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 (V3) end-of-study assessment and PET imaging to evaluate the endurance of changes in cognition, function, and behavior in the absence of further program use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Speed Training | Experimental | Other: Computerized speed-based cognitive trainingComputerized speed-based cognitive training requiring a total maximum of 70 treatment sessions, up to 7 sessions per week, 30 minutes per session. |
| Executive Function Training | Active comparator | Other: Computerized executive function cognitive trainingComputerized executive function cognitive 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
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Potential participant must be 65 years or older at the time of study screening.
- Potential participant must have MCI as defined by:
- Potential participant must have a study partner/informant defined as any acquaintance (e.g., family member, friend, neighbor, clinician) who has regular (at least monthly) interactions (in person or remote) with the participant.
- If potential participant reports use of medications typically prescribed for dementia such as, but not limited to, Namenda, Memantine, Namzaric, Donepezil, Aricept, Rivastigmine, Exelon, Razadyne, Galantamine, Reminyl, Aducanumab, Leqembi or Lecanemab, Donanemab, the dose must be stable for at least 12 weeks prior to study enrollment.
- Potential participant must demonstrate adequate decisional capacity, in the judgment of the investigator, and capable of to making an informed decision regarding their participation in this research study.
Key exclusion criteria (17 listed)
- Potential participant has an existing diagnosis of major neurocognitive disorder at screening (DSM-IV).
- Potential participant who answered 'yes' to question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the C-SSRS or 'yes' to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act or behavior) on the C-SSRS "Suicidal Behavior" if the ideation or behavior occurred within 2 months from Participant's date of consent (as recommended by the FDA for treatment trials.)
- Potential participant scores >10 on the Geriatric Depression Scale - Short Form (GDS-SF).
- Potential participant has previously completed 10 or more hours of the computerized cognitive intervention program manufactured by Posit Science.
- Potential participant is participating in a concurrent clinical trial (involving an investigational pharmaceutical, behavioral treatment, medical device or other) that, in the judgment of the 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 speed-based cognitive trainingThirty minutes of training on computerized exercises that targets visual processing speed, memory, attention and alertness. | Other | Speed Training |
| Computerized executive function cognitive trainingThirty minutes of training on computerized exercises that target executive function. | Other | Executive Function Training |
Primary outcome
Change in Global cholinergic signaling using [18F]fluoroethoxybenzovesamicol (FEOBV) positron-emission tomography (PET)
Time frame: at 3 months (post-intervention)
FEOBV standard uptake value ratios (SUVR) in the global cortex ROI. Higher score is better.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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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.
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 speed-based cognitive training and Computerized executive function cognitive training in people with Mild Cognitive Impairment, 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 10 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 21 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah-Jane Grant, MA (415-539-3130, sarah-jane.grant@positscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Global cholinergic signaling using [18F]fluoroethoxybenzovesamicol (FEOBV) positron-emission tomography (PET) (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?
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 21 Sep 2026.