RECRUITING

Training Response Artificial Intelligence Network (TRAIN)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Using Artificial Intelligence to Predict Cognitive Training Response in Amnestic Mild Cognitive Impairment

Quick Facts

Study Start:2023-10-09

Study Completion:2028-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05903573

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Joseph Gullett, Ph.D.

CONTACT

352-294-8631

gullettj@phhp.ufl.edu

Principal Investigator

Joseph Gullett, Ph.D.

PRINCIPAL_INVESTIGATOR

University of Florida

Study Locations (Sites)

University of Florida

Gainesville, Florida, 32610

United States

Collaborators and Investigators

Sponsor: University of Florida

Joseph Gullett, Ph.D., PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-09

Study Completion Date2028-04-30

Study Record Updates

Study Start Date2023-10-09

Study Completion Date2028-04-30

Terms related to this study

Additional Relevant MeSH Terms

Amnestic Mild Cognitive Impairment