NCT05903573 Training Response Artificial Intelligence Network (TRAIN)

Eligibility & Interventions

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What to Expect as a Participant

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This trial targets 75 participants in total. It began in 2023-10-09 with a primary completion date of 2028-04-30.

Brief Summary

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

Inclusion Criteria: * 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. * Global clinical dementia rating scale (CDR) score must be equal to 0.5 * Willingness to be randomized into either the educational training (control) or intervention (cognitive training) group * Able and willing to devote 12 weeks to the intervention with additional time for pre- and post-testing * Able and willing to perform cognitive and emotional measures both on paper and on a tablet computer * In line with the recommendations of the SCD task force, an informant must be available. This is to a) obtain information about the participant's complaints and cognitive difficulties on interview, and b) to ascertain validity of self-reported IADL function in regard to instrumental functional activities. Exclusion Criteria: * 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.) * Unstable and uncontrolled medical conditions (metastatic cancer, HIV, moderate-severe kidney disease, uncontrolled diabetes, uncontrolled hypertension, severe cardiac disease, etc.). No current cancer diagnosis * Current or past history of major psychiatric disturbance including schizophrenia, or active psychosis, bipolar disorder, current major depressive episode, current alcohol or substance abuse or history thereof within the past six months. The investigators are not excluding individuals who are taking antidepressant or anti-anxiety medications, however, use of these medications will be recorded and data analyzed in post-hoc analyses * Use of antipsychotics, sedatives, or other medications with significant anticholinergic properties (due to potential influence on memory) * Use of photo-sensitive medications such as steroids or retin-A within 15 days of the study intervention. * Previous participation in a cognitive training study within the last 6 months or current involvement in another study involving cognitive, physical or other intervention at the time of participation.

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