Training an AI to predict cognitive training responses in older adults
Using Artificial Intelligence to Predict Cognitive Training Response in Amnestic Mild Cognitive Impairment
This study is testing a new tool that uses AI to see how older adults with memory issues respond to a brain training program on an iPad over 16 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 55 Years to 100 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT05903573 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to develop a machine learning tool that predicts how older adults with amnestic mild cognitive impairment will respond to a cognitive training intervention. Participants will undergo baseline brain MRI scans and will be randomized into different cognitive training groups or an active control condition. The cognitive training will involve a self-administered, iPad-based program over 16 weeks, focusing on enhancing various cognitive skills. The study will evaluate the effectiveness of the training by measuring cognitive improvements compared to the control group.
Who should consider this trial
Good fit: Ideal candidates are older adults diagnosed with amnestic mild cognitive impairment who are willing to participate in cognitive training and meet specific cognitive performance criteria.
Not a fit: Patients with significant dementia or those who do not meet the cognitive performance criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to personalized cognitive training interventions that significantly improve cognitive function in older adults with mild cognitive impairment.
How similar studies have performed: Other studies have shown promise in using cognitive training interventions for similar populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Gainesville, Florida
- University of Florida — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Joseph Gullett, Ph.D. — University of Florida
- Study coordinator: Joseph Gullett, Ph.D.
- Email: gullettj@phhp.ufl.edu
- Phone: 352-294-8631
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.