ClinicalTrials.gg
RecruitingNCT07243600INHANCE-MCIUpdated Sep 21, 2026

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

An interventional study of Computerized speed-based cognitive training and Computerized executive function cognitive training in Mild Cognitive Impairment, sponsored by Posit Science Corporation. Recruiting at 1 site in Canada. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by Posit Science Corporation · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 223 studies in Cognitive Dysfunction with a site in Canada — 60 open to participants now, 79 under way, 7 of them phase 3. Cognitive Dysfunction · Canada.

Planned enrollment
73rd of 170
84 · median 62
Started
2026
with 9 others
No phase
115 of 223
36 open now
Primary completion
2027-05
later than 46 of 78 live
Registered
217th of 223
by date

Among the 223 studies in Cognitive Dysfunction with a site in Canada, this one is the 73rd largest by planned enrollment of the 170 interventional ones that give a count, is one of 10 that started in 2026, is one of 115 with no phase, reaches primary completion later than 46 of the 78 other live ones, and was the 217th registered.

Cognitive Dysfunction

3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.

Browse Cognitive Dysfunction studies →

Open to participants now

60 of the 223 studies in Cognitive Dysfunction with a site in Canada are open now. Recruiting first, the newest first:

54 more — sign in →

All 60 open studies →

A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →

Who these studies take

Of the 750 Cognitive Dysfunction studies recruiting now, 362 (48%) set no upper age limit and 143 (19%) stop at 75 or younger; 46 take children under 18; 259 take healthy volunteers.

This study: 65 Years and older · all sexes · no healthy volunteers.

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02

Study 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 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.

03

Conditions studied

  • Mild Cognitive Impairment
04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Potential participant must be 65 years or older at the time of study screening.
  2. Potential participant must have MCI as defined by:

    • Total score between 18-26 inclusive on the (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.
  3. 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.
  4. 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.
  5. 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.
  6. Potential participant must be likely able to complete all study activities and outcome measures in the judgment of the investigator.
  7. Potential participant must have the visual, auditory, and motors capacity to use the computerized intervention in the judgment of the investigator.
  8. Potential participant must be able to communicate in either English or French.

Exclusion criteria

Exclusion Criteria:

  1. Potential participant has an existing diagnosis of major neurocognitive disorder at screening ().
  2. 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.)
  3. Potential participant scores >10 on the Geriatric Depression Scale - Short Form (GDS-SF).
  4. Potential participant has previously completed 10 or more hours of the computerized cognitive intervention program manufactured by Posit Science.
  5. Potential participant is participating in a concurrent clinical trial (involving an pharmaceutical, behavioral treatment, medical device or other) that, in the judgment of the investigator, could affect the outcome of this study.
  6. Potential participant is pregnant or breastfeeding.
  7. 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.
  8. Potential participant has a history of large vessel stroke with significant residual motor or cognitive impairment.
  9. Potential participant has a history of moderate to severe traumatic brain injury with residual cognitive symptoms.
  10. Potential participant has a history of brain tumor.
  11. Potential participant has a congestive heart failure diagnosis.
  12. Potential participant has a primary diagnosis of idiopathic Parkinson's disease.
  13. Potential participant has multiple sclerosis or Amyotrophic lateral sclerosis diagnosis.
  14. Potential participant has evidence of a non-neurodegenerative neurological disorder that would interfere with the ability to carry out study activities.
  15. 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).
  16. Potential participant has any other 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.
  17. 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).
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
84 participants (estimated)

Study arms

  • Experimental
    Speed Training

    Computerized speed-based cognitive training requiring a total maximum of 70 treatment sessions, up to 7 sessions per week, 30 minutes per session.

    Other: Computerized speed-based cognitive training

  • Active comparator
    Executive Function Training

    Computerized executive function cognitive training requiring a total maximum of 70 treatment sessions, up to 7 sessions per week, 30 minutes per session.

    Other: Computerized executive function cognitive training

Interventions

  • OtherComputerized speed-based cognitive training

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

  • OtherComputerized executive function cognitive training

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: at 3 months (post-intervention)

Other outcomes

  1. Change in Memory-based cholinergic signaling in hippocampus gyrus using [18F]fluoroethoxybenzovesamicol (FEOBV) positron-emission tomography (PET)

    FEOBV-PET standard uptake value ratios (SUVR) hippocampus gyrus using Matched MNI-space region via Hammers Atlas. Higher score is better.

    Time frame: at 3 months (post-intervention)

  2. Change in Memory-based cholinergic signaling in parahippocampal gyrus using [18F]fluoroethoxybenzovesamicol (FEOBV) positron-emission tomography (PET)

    FEOBV-PET standard uptake value ratios (SUVR) parahippocampal gyrus using Matched MNI-space region via Hammers Atlas. Higher score is better

    Time frame: at 3 months (post-intervention)

  3. Change in NIH EXAMINER Executive Composite Score

    The NIH EXAMINER is a computer based battery of executive function tests which yields a total or 'composite' score to represent global executive functioning. Higher score is better.

    Time frame: at 3 months (post-intervention) and at 6 months (follow-up)

  4. Change in Clinical Dementia Rating Sum of Boxes (CDR-SB) Score

    The Clinical Dementia Rating (CDR) Scale is a validated assessment for evaluating severity of dementia. Lower score is better.

    Time frame: at 3 months (post-intervention) and at 6 months (follow-up)

  5. Change in Double Decision train-to-task Assessment Score

    This is a computerized assessment that serves as a positive control for task learning. A single exposure duration (in milliseconds) required for users to achieve approximately 80% criterion accuracy in identification of central and peripheral targets. Higher score is better.

    Time frame: at 3 months (post-intervention) and at 6 months (follow-up)

  6. Change in Eye-tracking Test

    Eye movements will be measured to determine acetylcholinergic function over time. A series of oculomotor tasks will be presented sequentially on an iPad Pro for approximately 20 minutes. Each task consists of visual stimuli designed to elicit specific eye movements. The iPad's front-facing camera will record facial and eye movements during task performance.

    Time frame: at 3 months (post-intervention) and at 6 months (follow-up)

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for May 2027, 8 months later.

Of 69 industry-sponsored interventional studies with no phase under Cognitive Dysfunction, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 35. This study's planned 8 months is below that.

Counting every sponsor, half of 1,511 studies reached it within 27 months; a quarter within 12 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 14, 2025
First posted
Nov 24, 2025
StartEst.
Sep 25, 2026
Primary completionEst.
May 31, 2027
CompletionEst.
May 31, 2027
Last update
Sep 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07243600
Collaborators
McGill University
Responsible party
Sponsor
First posted
Nov 24, 2025
Start date
Sep 25, 2026 (estimated)
Primary completion
May 31, 2027 (estimated)
Completion
May 31, 2027 (estimated)
Last update
Sep 21, 2026

Study contacts

Sarah-Jane Grant, MA
Contact
sarah-jane.grant@positscience.com
415-539-3130
Mouna Attarha, PhD
principal investigator · Posit Science Corporation

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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