Recruiting

Observational Study

Sponsor:

University of Florida

Code:

NCT05903573

Conditions

Amnestic Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

Interventions

Cognitive Training

Computerized Cognitive Stimulation

Study Details

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

Study ID

NCT05903573

Start date

Oct 9, 2023

Status verified date

Dec, 2025

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Apr 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention Group: Cognitive Training

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.

active comparator: Active Control Group: Computerized Cognitive Stimulation

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.

Interventions

Cognitive Training

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.

Computerized Cognitive Stimulation

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.

Primary outcome measure

  • Useful Field of View Composite [ Time Frame: Baseline up to week 12 during follow-up ]

Central Contacts and Locations

Central contacts

Joseph Gullett, Ph.D.

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

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Joseph Gullett, PhD

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

Principal Investigator:

Joseph M Gullett, PhD

More Information

Sponsor

University of Florida

Last update posted

Dec 4, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2025-12-04.