Recruiting

Cognitive Training

Sponsor:

Posit Science Corporation

Code:

NCT07243600

Conditions

Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Computerized speed-based cognitive training

Computerized executive function cognitive training

Study Details

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

Study ID

NCT07243600

Start date

Sep 25, 2026

Status verified date

Sep, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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 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.
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:

1. Potential participant has an existing diagnosis of major neurocognitive disorder at screening (DSM-IV).
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 investigational 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 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.
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).

Study Design

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

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.

Interventions

Computerized speed-based cognitive training

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

Computerized executive function cognitive training

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

Primary outcome measure

  • Change in Global cholinergic signaling using [18F]fluoroethoxybenzovesamicol (FEOBV) positron-emission tomography (PET) [ Time Frame: at 3 months (post-intervention) ]

Central Contacts and Locations

Central contacts

Locations

Montreal Neurological Institute-Hospital

Recruiting

Montreal, Quebec, Canada, H3A 2B4

Contacts

Principal Investigator:

Etienne de Villers-Sidani, PhD

More Information

Sponsor

Posit Science Corporation

Last update posted

Sep 21, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Posit Science Corporation on 2026-09-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.