75 Participants Needed

Brain Training for Mild Cognitive Impairment

JG
Overseen ByJoseph Gullett, Ph.D.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot use antipsychotics, sedatives, or medications with significant anticholinergic properties. Also, you should not use photo-sensitive medications like steroids or retin-A within 15 days of the study.

What data supports the effectiveness of the treatment TRAIN, Cognitive Training Intervention, Machine Learning Tool for Cognitive Training for Mild Cognitive Impairment?

Research shows that cognitive training can help maintain or slightly improve memory in people with mild cognitive impairment (MCI), especially in those with certain biological traits like a larger left entorhinal cortex. Additionally, cognitive training has been shown to improve verbal memory and increase brain activity in areas related to memory, suggesting it can be beneficial for people with MCI.12345

Is brain training for mild cognitive impairment safe for humans?

The studies suggest that brain training for mild cognitive impairment is generally safe for humans, as participants in various trials, including those with mild cognitive impairment, completed the training without significant safety concerns. However, more research is needed to confirm these findings across larger and more diverse groups.16789

How does brain training differ from other treatments for mild cognitive impairment?

Brain training for mild cognitive impairment is unique because it uses computer-based exercises to improve cognitive abilities by enhancing brain plasticity (the brain's ability to change and adapt). Unlike medications, which have generally not been successful for this condition, brain training targets specific cognitive skills and neural networks to potentially improve overall cognitive function.410111213

Research Team

JG

Joseph M Gullett, PhD

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for older adults with mild cognitive impairment who have a close informant to report on their cognition, can handle daily activities despite some difficulties, and score within normal limits on a cognitive screening. They must not be dependent on certain medications or have conditions like dementia, major psychiatric disturbances, uncontrolled medical issues, or past participation in similar studies.

Inclusion Criteria

Global clinical dementia rating scale (CDR) score must be equal to 0.5
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 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.
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Exclusion Criteria

I do not have any uncontrolled health conditions or a current cancer diagnosis.
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.
I do not have significant vision or hearing loss that would prevent me from participating in study tasks.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline brain MRI sequences and neuropsychological assessments are conducted

1 month
1 visit (in-person)

Treatment

Participants undergo cognitive training using the Posit Science Brain HQ Suite for 16 weeks

16 weeks
Self-administered 2-3 days/week

Follow-up

Participants are monitored for cognitive improvements and changes in UFOV composite score

12 weeks
Assessments at end of treatment

Treatment Details

Interventions

  • TRAIN
Trial OverviewThe TRAIN study uses brain MRI data from participants to train an AI tool that predicts how well they'll respond to computerized cognitive training designed for those with memory impairments. Participants will either receive this training or educational training (control) over 12 weeks.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention Group: Cognitive TrainingExperimental Treatment1 Intervention
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.
Group II: Active Control Group: Computerized Cognitive StimulationActive Control1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

National Institute on Aging (NIA)

Collaborator

Trials
1,841
Recruited
28,150,000+

Findings from Research

Cognitive training in patients with mild cognitive impairment (MCI) showed small benefits for memory functions, with a study of 25 participants indicating that those with a larger left entorhinal cortex and higher motivation experienced more improvement in episodic memory after treatment.
Participants who did not receive cognitive training experienced a significant decline in episodic memory, highlighting the potential of cognitive interventions to stabilize or enhance memory functions in MCI patients, especially when tailored to individual biological factors.
Biological Factors Contributing to the Response to Cognitive Training in Mild Cognitive Impairment.Peter, J., Schumacher, LV., Landerer, V., et al.[2018]
A pilot study involving 32 older adults with Mild Cognitive Impairment (MCI) found that Gist Reasoning training led to significant changes in neural activity, specifically increased theta synchronization and enhanced alpha band desynchronization during cognitive tasks, indicating improved neural processing.
The results suggest that Gist Reasoning training may be more effective than New Learning training in promoting neuroplasticity and cognitive function in individuals with MCI, particularly in tasks requiring higher-order reasoning.
Event-related neural oscillation changes following reasoning training in individuals with Mild Cognitive Impairment.Mudar, RA., Nguyen, LT., Eroh, J., et al.[2022]
Cognitive speed of processing training (SOPT) was effective in improving cognitive function in older adults with mild cognitive impairment (MCI), with all subtypes showing immediate benefits post-training compared to controls.
The single non-amnestic subtype of MCI experienced the most significant improvements, and all subtypes maintained their training gains over five years, suggesting the durability of SOPT's effects.
The effects of cognitive speed of processing training among older adults with psychometrically- defined mild cognitive impairment.Valdes, EG., O'Connor, ML., Edwards, JD.[2019]

References

Biological Factors Contributing to the Response to Cognitive Training in Mild Cognitive Impairment. [2018]
Event-related neural oscillation changes following reasoning training in individuals with Mild Cognitive Impairment. [2022]
3.United Arab Emiratespubmed.ncbi.nlm.nih.gov
The effects of cognitive speed of processing training among older adults with psychometrically- defined mild cognitive impairment. [2019]
A single case study of computerised cognitive training for older persons with mild cognitive impairment. [2018]
Cognitive training changes hippocampal function in mild cognitive impairment: a pilot study. [2022]
Computer-based cognitive training for mild cognitive impairment: results from a pilot randomized, controlled trial. [2022]
Preliminary evidence for the feasibility of at-home online cognitive training with older adults. [2022]
Assessment of cognition in mild cognitive impairment: a comparative study. [2022]
Biomarkers of Cognitive Training Effects in Aging. [2023]
Cognitive training and neuroplasticity in mild cognitive impairment (COG-IT): protocol for a two-site, blinded, randomised, controlled treatment trial. [2020]
Computerized cognitive training for Chinese mild cognitive impairment patients: A neuropsychological and fMRI study. [2020]
Unifying framework for cognitive training interventions in brain aging. [2023]
SMR/Theta Neurofeedback Training Improves Cognitive Performance and EEG Activity in Elderly With Mild Cognitive Impairment: A Pilot Study. [2020]