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

NCT07243600 | Not Yet Recruiting DMC

• 1 other identifier: PSC-0703-25
• Study Type: interventional
• Target: 84
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Mild Cognitive Impairment

Outcome Measures

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.

  at 3 months (post-intervention)

Other Outcomes (6)

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

  at 3 months (post-intervention)

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

  at 3 months (post-intervention)

• Change in NIH EXAMINER Executive Composite Score

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

Study Arms (2)

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.

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.

Other: Computerized executive function cognitive training

Interventions

Computerized speed-based cognitive training OTHER

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

Speed Training

Computerized executive function cognitive training OTHER

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

Executive Function Training

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Posit Science Corporation: lead
• McGill University: collaborator

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Mouna Attarha, PhD

  Posit Science Corporation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah-Jane Grant, MA

CONTACT

415-539-3130; sarah-jane.grant@positscience.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 24, 2025
• Study Start: May 5, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03