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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorPosit Science Corporation

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Potential participant must be 65 years or older at the time of study screening.

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Computerized speed-based cognitive training

    Other intervention

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

  • Computerized executive function cognitive training

    Other intervention

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

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: Speed TrainingExperimental treatment 1 intervention
Group B: Executive Function TrainingActive comparator 1 intervention

Trial outcomes

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)

Secondary outcomes

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)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Posit Science Corporation

Lead sponsor

McGill University

Collaborator