Brain Training for Mild Cognitive Impairment

Overseen By Joseph Gullett, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must not be taking: Antipsychotics, Sedatives, Anticholinergics, Steroids

Disqualifiers: Sensory loss, Major strokes, Uncontrolled conditions, Psychiatric disturbance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 16 weeks

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether brain training can improve memory in individuals with mild cognitive issues related to memory. Researchers will use brain scans to predict who might benefit most from the training. Participants will either engage in a specific brain training program (called TRAIN) or participate in other mentally stimulating computer activities. The trial seeks individuals who have noticed memory changes but can still manage daily tasks independently. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on cognitive health.

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 prior data suggests that this cognitive training intervention is safe for individuals with mild cognitive impairment?

Research has shown that computerized brain training is generally safe and well-tolerated. Studies have tested this type of training, such as the one used in the TRAIN program, on people with mild memory and thinking problems without major safety concerns. Participants typically perform the exercises on a computer, which includes activities to enhance memory and thinking skills.

In these studies, few side effects were reported. Most participants found the training manageable, experiencing only minor issues like eye strain or tiredness, similar to what one might feel after extended computer use. No serious side effects were reported. This suggests that the brain training used in this trial is likely safe for people with mild cognitive issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the cognitive training being tested because it offers a non-drug approach to managing mild cognitive impairment. Unlike the standard medications that primarily target symptoms, this method focuses on enhancing brain function through interactive exercises. Delivered via the Posit Science Brain HQ platform, it provides a personalized experience that adapts to individual progress, potentially leading to significant cognitive improvements over time. This tech-driven approach represents a shift towards leveraging digital tools for brain health, making it an innovative option in the field.

What evidence suggests that this cognitive training intervention is effective for mild cognitive impairment?

Research has shown that computer-based brain exercises can improve memory in people with mild cognitive impairment (MCI). In this trial, participants in the intervention group will use a cognitive training program called TRAIN, which involves interactive brain exercises. One study found that an interactive tool for brain exercises was promising for patients with Alzheimer's, a condition similar to MCI. Researchers also found that personalized brain training programs can be effective for people with MCI. These programs boost brain function through specific exercises. Early results suggest that these training methods could help manage MCI symptoms. ^{1 2 3 5 6}

Who Is on the Research Team?

Joseph M Gullett, PhD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

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 any uncontrolled health conditions or a current cancer diagnosis.

I do not have significant vision or hearing loss that would prevent me from participating in study tasks.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• TRAIN

Trial Overview The 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.

How Is the Trial Designed?

Group I: Intervention Group: Cognitive Training Experimental Treatment 1 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 Stimulation Active Control 1 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.

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+

Published Research Related to This Trial

This study will evaluate the effectiveness of home-based computerized cognitive training (CCT) in improving cognitive abilities in 100 patients with mild cognitive impairment (MCI) over 12 weeks, with follow-up booster sessions for up to 78 weeks.

The trial aims to assess not only cognitive improvements but also changes in brain structure and function, specifically looking at hippocampal volume and the default mode network, using MRI scans, making it a comprehensive approach to understanding the impact of CCT on MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive training and neuroplasticity in mild cognitive impairment (COG-IT): protocol for a two-site, blinded, randomised, controlled treatment trial. D'Antonio, J., Simon-Pearson, L., Goldberg, T., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Event-related neural oscillation changes following reasoning training in individuals with Mild Cognitive Impairment. Mudar, RA., Nguyen, LT., Eroh, J., et al.[2022]

In a pilot study involving 20 elderly patients with mild cognitive impairment (MCI), sensorimotor (SMR)/theta neurofeedback training over 10 weeks led to significant improvements in cognitive assessments, including the Montreal Cognitive Assessment and the Wechsler Adult Intelligence Scale.

The training also resulted in increased EEG theta and alpha power, indicating enhanced brain activity, with these improvements sustained at a 1-month follow-up, suggesting that neurofeedback could be a promising non-invasive method for cognitive rehabilitation in the elderly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SMR/Theta Neurofeedback Training Improves Cognitive Performance and EEG Activity in Elderly With Mild Cognitive Impairment: A Pilot Study. Marlats, F., Bao, G., Chevallier, S., et al.[2020]

A pilot study involving 47 participants with mild cognitive impairment showed that intensive, computer-based cognitive training improved neuropsychological assessment scores by 0.36 standard deviations, although this was not statistically significant compared to the control group.

The study suggests that while the cognitive training may have specific benefits for verbal learning and memory, further research with larger sample sizes is needed to confirm these effects and explore their potential domain-specific impacts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-based cognitive training for mild cognitive impairment: results from a pilot randomized, controlled trial. Barnes, DE., Yaffe, K., Belfor, N., et al.[2022]

There is a growing need for quick and reliable cognitive assessments to identify early signs of cognitive decline, especially as research shifts towards developing treatments for Alzheimer's disease before symptoms appear.

This review systematically evaluates 16 cognitive measures, primarily computer-based, to determine their effectiveness in distinguishing between healthy individuals and those showing subtle cognitive changes, providing a framework for selecting appropriate tools for clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of cognition in mild cognitive impairment: a comparative study. Snyder, PJ., Jackson, CE., Petersen, RC., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biological Factors Contributing to the Response to Cognitive Training in Mild Cognitive Impairment. Peter, J., Schumacher, LV., Landerer, V., et al.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The Chinese-version computer-based multi-model cognitive training for mild cognitive impairment (MCI) patients showed cognitive benefits, particularly in memory and attention, after 6 months of training, with 78 patients in the training group demonstrating a 0.23 standard deviation improvement in mini-mental state examination scores.

Functional MRI results indicated increased neural activity in areas associated with memory and cognition, such as the hippocampus, although the long-term effects of the training were not significant after a 12-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized cognitive training for Chinese mild cognitive impairment patients: A neuropsychological and fMRI study. Li, BY., He, NY., Qiao, Y., et al.[2020]

Cognitive training has potential to slow or prevent cognitive decline in older adults at risk for dementia, but its effectiveness has been limited by a lack of evidence for broad improvements across different cognitive areas.

The proposed framework suggests enhancing cognitive training by tailoring tasks to individual cognitive characteristics and using feedback loops to optimize the training experience, which may lead to better overall brain function and real-world benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unifying framework for cognitive training interventions in brain aging. Turnbull, A., Seitz, A., Tadin, D., et al.[2023]

An online cognitive training program (CogniFit™) showed promise in improving working memory and processing speed in older adults, including those with mild cognitive impairment, based on assessments before and after the training.

While participants generally adhered to the training, those with mild cognitive impairment showed lower adherence, indicating that more direct support may be necessary for this group to benefit fully from cognitive interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary evidence for the feasibility of at-home online cognitive training with older adults. Gigler, KL., Blomeke, K., Shatil, E., et al.[2022]

Cognitive training in healthy aging individuals is linked to structural brain improvements, such as increased brain volume and cortical thickness, as well as enhanced white matter integrity.

In individuals with mild cognitive impairment (MCI), cognitive training boosts brain metabolism and task-related activation, suggesting potential benefits for cognitive function, though further research is needed to confirm these effects across larger and more diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomarkers of Cognitive Training Effects in Aging. Belleville, S., Bherer, L.[2023]

In a study involving two older adults with Amnestic Mild Cognitive Impairment, cognitive training led to improved performance on untrained measures of attention and reasoning for one participant after 40 training sessions.

Both participants reported fewer cognitive failures in daily life and improved mood after completing the training, suggesting potential benefits of cognitive training beyond the specific tasks practiced.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A single case study of computerised cognitive training for older persons with mild cognitive impairment. Finn, M., McDonald, S.[2018]

In a randomized pilot study involving participants with mild cognitive impairment (MCI), cognitive training led to significant improvements in verbal memory and increased activation in the left hippocampus after two months.

The results indicate that the hippocampus in individuals with MCI retains enough neuroplasticity to benefit from cognitive training, as evidenced by improvements in 5 out of 6 participants in the experimental group compared to declines in all participants in the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive training changes hippocampal function in mild cognitive impairment: a pilot study. Rosen, AC., Sugiura, L., Kramer, JH., et al.[2022]

Citations

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Training Response Artificial Intelligence Network (TRAIN) This study will train a machine learning tool to predict response to a cognitive training intervention using baseline brain MRI sequences ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2760033/

Computer-Based Cognitive Training for Mild ... A randomised pilot study to assess the efficacy of an interactive, multimedia tool of cognitive stimulation in Alzheimer's disease. J Neurol Neurosurg ...

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Computerized cognitive training for memory functions in ... A randomised pilot study to assess the efficacy of an interactive, multimedia tool of cognitive stimulation in Alzheimer's disease. ... training ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1568163710001121

Review Cognitive intervention for persons with mild ... Researchers report that errorless learning is an effective memory rehabilitation tool for persons with MCI (Akhtar et al., 2006). Schreiber and Schneider (2007) ...

5. bmcmedicine.biomedcentral.com bmcmedicine.biomedcentral.com/articles/10.1186/s12916-024-03647-x

Individualised computerised cognitive training (iCCT) for ... Cognitive intervention programmes on patients affected by mild cognitive impairment: a promising intervention tool for MCI? J Nutr Health ...

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06348810

Dual-Task Training for People With Mild Cognitive ... This instrument consists of a 19-item self-rated questionnaire to assess sleep quality during the last month, which includes seven domains, i.e., subjective ...