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View on ClinicalTrials.gov

Comparing Computerized speed-based cognitive with Computerized executive function for mild cognitive impairment

Official title: Improving Neurological Health With Acetylcholine Via Neuroplasticity-based Computerized Exercise in Mild Cognitive Impairment

Improving Neurological Health With Acetylcholine Via Neuroplasticity-based Computerized Exercise in Mild Cognitive Impairment (INHANCE-MCI)

Condition: Mild Cognitive ImpairmentSponsor: Posit Science CorporationTarget enrollment: 84
  • 2 groups
  • One site, in Montreal
  • Recruiting
Montreal Neurological Institute-Hospital, Montreal, Quebec

Interventions

  • Other intervention

    Computerized speed-based cognitive training

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

  • Other intervention

    Computerized executive function cognitive training

    Thirty minutes of training on computerized exercises that target executive function.

Canadian Sites (1)

1 of 1 recruiting

  • Montreal Neurological Institute-Hospital

    Montreal, Quebec

    Recruiting

Eligibility Criteria

See who this study is looking for27 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

  • +Total score between 18-26 inclusive on the Montreal Cognitive Assessment (MoCA)
  • +Potential participant must be 65 years or older at the time of study screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
  • +Potential participant must have MCI as defined by:
  • +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 enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →.
  • +Potential participant must demonstrate adequate decisional capacity, in the judgment of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, 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 measuresEndpointThe specific thing a study measures to answer its question.Read more → 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.

Exclusion

  • Potential participant has an existing diagnosis of major neurocognitive disorder at screeningScreeningThe checks done before joining, to see whether a study fits.Read more → (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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → (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 trialInterventional studyA study where participants are given something to see what happens.Read more → (involving an investigational pharmaceutical, behavioral treatment, medical device or other) that, in the judgment of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, could affect the outcome of this study.
  • 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 pregnant or breastfeeding.
  • 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 enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → later).
5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning 
What this study is

This study is testing a treatment for a condition.

This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.

From the trial registry

Built from these fields:

  • designModule.designInfo.primaryPurpose
  • designModule.phases
Who receives what

There are 2 groups in this study.

Group A receives Computerized speed-based cognitive training.

Registry label: A: Speed Training

Group B, the comparison group, receives Computerized executive function cognitive training.

Registry label: B: Executive Function Training

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].label
  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.

From the trial registry

Built from these fields:

  • designModule.designInfo.allocation
  • designModule.designInfo.maskingInfo.masking
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment, so the two can be compared.

From the trial registry

Built from these fields:

  • armsInterventionsModule.armGroups[].type
  • armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for

The study lists a minimum age of 65 years, with no upper limit given.

The study is open to people of any sex.

The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.

From the trial registry

Built from these fields:

  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How big and how long

The study aims to enrol about 84 people.

The study is currently expected to finish around May 2027.

The main measurement is taken over: at 3 months (post-intervention).

From the trial registry

Built from these fields:

  • designModule.enrollmentInfo.count
  • statusModule.completionDateStruct.date
  • outcomesModule.primaryOutcomes[].timeFrame
What the study measures

Change in Global cholinergic signaling using [18F]fluoroethoxybenzovesamicol (FEOBV) positron-emission tomography (PET) — measured over at 3 months (post-intervention).

From the trial registry

Built from these fields:

  • outcomesModule.primaryOutcomes[].measure
  • outcomesModule.primaryOutcomes[].timeFrame

Source: NCT07243600 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?

What is being tested — in plain terms

About Computerized speed-based cognitive trainingOther

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

From the trial registry — its own words, unedited.

What a other is here: An intervention the registry did not place in another category.

Read the full explanation → · in clinical review

About Computerized executive function cognitive trainingOther

Thirty minutes of training on computerized exercises that target executive function.

From the trial registry — its own words, unedited.

What a other is here: An intervention the registry did not place in another category.

Read the full explanation → · in clinical review

Common questions

Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.

Am I eligible for this trial?

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.

What the study lists: a minimum age of 65 years.

The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.

The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.eligibilityCriteria
Is there a placebo?

This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.

One group receives an existing treatment so the two can be compared.

From the trial registry
  • armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?

You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

From the trial registry
  • designModule.designInfo.maskingInfo.masking
  • designModule.designInfo.allocation
Who can join?

The study lists a minimum age of 65 years, with no upper limit given.

It is open to people of any sex.

It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.

Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.

From the trial registry
  • eligibilityModule.minimumAge
  • eligibilityModule.sex
  • eligibilityModule.healthyVolunteers
How long would this take?

The study's main measurement is taken over: at 3 months (post-intervention).

The study as a whole is currently expected to finish around 2027-05-31.

How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.

From the trial registry
  • outcomesModule.primaryOutcomes[].timeFrame
  • statusModule.completionDateStruct.date
How many people are taking part?

The study aims to enrol about 84 people.

From the trial registry
  • designModule.enrollmentInfo.count
Where is this happening?

This study lists one location: Montreal, Quebec, Canada.

Sites can open and close during a study, so confirm with the team before travelling.

From the trial registry
  • trial_locations

About This Trial

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).

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This page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.