Training Response Artificial Intelligence Network (TRAIN)
ConditionAmnestic Mild Cognitive Impairment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-100
SponsorUniversity of Florida
About this trial
This study will train a machine learning tool to predict response to a cognitive training intervention using baseline brain MRI sequences from older adults with amnestic mild cognitive impairment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Evidence of changed cognition reported by a close informant as obtained by an interview with a licensed clinical psychologist (PI, Gullett)
Cognitive performance on one or more standardized neuropsychological measures of verbal or non-verbal memory > 1.0 standard deviation or more below the normative mean for age and education
No evidence of reported dependence in instrumental functional abilities (IADLs) despite reported cognitive difficulties
No evidence of dementia based on cognitive screening (Montreal Cognitive Assessment Score within normal limits for age, education, and sex using the NACC Uniform Data Set (UDS) norms.
Disqualifiers
Sensory loss (vision, hearing) or motor deficits that would preclude participation in the experimental tasks or neuropsychological assessment
English as a second language
Inability to undergo brain imaging due to claustrophobia or implants such as pacemakers, heart valves, brain aneurysm clips, orthodontics, non-removable body jewelry, or shrapnel containing ferromagnetic metal
Previous major strokes or other known significant brain abnormalities or diseases affecting the brain and/or cognition (e.g., Parkinson disease, multiple sclerosis, seizure disorder, brain surgery, moderate TBI, REM Behavior Sleep Disorder, untreated sleep apnea, etc.)
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive Training
BehavioralThe intervention group will receive cognitive training that provides specific training tasks directed at essential cognitive domains tied to the project's aims and hypotheses (processing speed and working memory) that correspond with the neurocognitive and functional neuroimaging measures to be studied.
Computerized Cognitive Stimulation
BehavioralParticipants will complete cognitively-stimulating computer activities. The duration is 60 min/day; the frequency is two to three days/wk, for 16 weeks with the goal of completing 40 sessions.
Treatment groups
75 Participants
are divided into 2 treatment groupsGroup A: Intervention Group: Cognitive TrainingExperimental treatment 1 intervention
Group B: Active Control Group: Computerized Cognitive StimulationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Useful Field of View Composite
The Useful Field of View (UFOV) composite change score is calculated by subtracting the post-intervention score (0-500) from the pre-intervention score (0-500), where a more negative change score is indicative of stronger improvement after intervention (range +500 to -500).
Time frame
Baseline up to week 12 during follow-upSponsors and contacts
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University of Florida
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov