Training Response Artificial Intelligence Network (TRAIN)

NCT05903573 | Recruiting

• 2 other identifiers: IRB202201517K23AG080127
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Amnestic Mild Cognitive Impairment

Outcome Measures

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).

  Baseline up to week 12 during follow-up

Study Arms (2)

Intervention Group: Cognitive Training

EXPERIMENTAL

Participants will complete computerized cognitive training via Posit Science Brain HQ. The duration is 60 min/day; the frequency is two to three days/wk, for 16 weeks with the goal of completing 40 sessions.

Behavioral: Cognitive Training

Active Control Group: Computerized Cognitive Stimulation

ACTIVE COMPARATOR

Participants 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.

Behavioral: Computerized Cognitive Stimulation

Interventions

Computerized Cognitive Stimulation BEHAVIORAL

Participants 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.

Active Control Group: Computerized Cognitive Stimulation

Cognitive Training BEHAVIORAL

The 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.

Intervention Group: Cognitive Training

Eligibility Criteria

• Age: 55 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

MeSH Terms

Interventions

Cognitive Training

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Joseph Gullett, Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Gullett, Ph.D.

CONTACT

352-294-8631; gullettj@phhp.ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 15, 2023
• Study Start: October 9, 2023
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)