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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Computerized speed-based cognitive training
Other interventionThirty minutes of training on computerized exercises that targets visual processing speed, memory, attention and alertness.
Computerized executive function cognitive training
Other interventionThirty minutes of training on computerized exercises that target executive function.
Treatment groups
Trial outcomes
Primary outcomes
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.
Other outcomes
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.
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
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.
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.
Sponsors and contacts
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Posit Science Corporation
Lead sponsor
McGill University
Collaborator