Cognitive Training for Mild Cognitive Impairment

Recruiting at 4 trial locations

Overseen By Marlayna Cromedy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Dementia, Stroke, Parkinson's, others

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

Compensation: Varies

Number of Visits: 2

Duration: 16 weeks

1305 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the optimal combination of brain exercises to help individuals with mild cognitive impairment (MCI) enhance their daily living skills and potentially delay dementia onset. Participants will engage in various combinations of computerized cognitive training sessions, also known as cognitive therapy or brain training. The study seeks individuals who have noticed changes in their thinking abilities and have been diagnosed with MCI. Participants should be able to use a computer and be willing to commit to all study activities. As an unphased trial, this study provides a unique opportunity to contribute to understanding the impact of cognitive training on MCI.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking medications typically prescribed for dementia, like Namenda or Aricept, your dose must have been stable for at least 30 days before joining the study.

What prior data suggests that these cognitive training exercises are safe for older adults with mild cognitive impairment?

Research shows that computerized cognitive training (CCT) is generally safe for older adults. Studies have found that this training can improve mental abilities like memory and attention without causing harm. Specifically, previous research found CCT to be a safe and effective way to enhance mental function in people with mild cognitive impairment (MCI).

No major reports of negative side effects link to CCT, indicating participants usually handle this training well. Additionally, cognitive training is a common and trusted method for helping people with cognitive issues and improving brain health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about cognitive training for mild cognitive impairment because it offers a non-invasive and personalized approach to boost brain function. Unlike standard treatments that often rely on medications to manage symptoms, these computerized cognitive exercises aim to directly enhance cognitive skills through targeted mental challenges. This method leverages technology to engage and potentially improve brain plasticity, allowing for tailored interventions that can be adjusted based on individual progress. The potential for cognitive training to empower patients to take an active role in managing their cognitive health is a promising development in the field.

What evidence suggests that this trial's cognitive training treatments could be effective for mild cognitive impairment?

Research has shown that computerized cognitive training (CCT), which participants in this trial may receive, can help people with mild cognitive impairment (MCI) improve memory and thinking skills. For example, a study with 1,489 participants with MCI found that CCT significantly improved verbal memory and also aided visual memory. Another study found that engaging in multi-tasking CCT three times a week significantly enhanced thinking skills over six months. In this trial, some participants will receive computerized cognitive stimulation (CS), which also positively affects thinking skills and can help reduce symptoms of depression. Overall, both CCT and CS show promise for improving brain function in people at risk for dementia. ^{2 6 7 8 9}

Who Is on the Research Team?

Jerri Edwards, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

Adults aged 55-89 with mild cognitive impairment (MCI) are eligible for this trial. They must have a certain score on a cognitive assessment, stable medication use, and changes in cognitive function from their baseline. Participants need to be able to see, hear, and use a computer. Those with severe dementia or other major health issues that affect cognition or study participation are excluded.

Inclusion Criteria

I am between 55 and 89 years old.

I understand and can follow the study's procedures.

I can hear normal speech in at least one ear.

Exclusion Criteria

Your score on the Geriatric Depression short scale is higher than 5 out of 15. If you have a mood disorder that is controlled with treatment and your score is lower than 6 out of 15, you are not excluded.

You cannot have an MRI because you have a pacemaker, metal implants in your body, or feel very scared in small spaces.

I have been diagnosed with dementia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cognitive training exercises aimed at improving instrumental activities of daily living (IADL) and delaying dementia onset

16 weeks

2-3 visits per week (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of dementia incidence and cognitive function

6 months to 2 years

Periodic follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Training
• Computerized Cognitive Stimulation

Trial Overview The trial is testing different combinations of cognitive training exercises against computerized cognitive stimulation to improve daily living activities and delay the onset of dementia in older adults at risk. It includes neuroimaging and blood biomarker analysis to identify the most effective CT combination.

How Is the Trial Designed?

Group I: CTac Experimental Treatment 1 Intervention

Participants will complete computerized cognitive training. 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: CTabc Experimental Treatment 1 Intervention

Participants will complete computerized cognitive training. 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 III: CTab Experimental Treatment 1 Intervention

Participants will complete computerized cognitive training. 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 IV: CTa Experimental Treatment 1 Intervention

Participants will complete computerized cognitive training. 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 V: 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 Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+

University of Florida

Collaborator

Trials

1,428

Recruited

987,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Clemson University

Collaborator

Trials

38

Recruited

8,200+

Published Research Related to This Trial

A study involving 71 participants with mild cognitive impairment (MCI) found that all three formats of language training (computer, paper/pencil, and oral) significantly improved cognitive abilities compared to control groups over 48 sessions across 6 months.

Participants in the experimental groups showed enhancements in cognitive abilities and daily functioning, while control groups did not show any improvement, indicating the effectiveness of structured cognitive training for MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Comparative Single-Blind Randomized Controlled Trial With Language Training in People With Mild Cognitive Impairment. Poptsi, E., Lazarou, I., Markou, N., et al.[2020]

A study involving 50 community-dwelling adults with mild cognitive impairment (MCI) found that those receiving home-based computerized cognitive training (HB-CCT) showed significant improvements in cognitive function and depression after eight weeks, while the control group did not.

The HB-CCT intervention was safe, with no reported side effects, indicating it could be a beneficial tool for enhancing cognitive abilities in adults with MCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Home-Based Computerized Cognitive Training in Community-Dwelling Adults With Mild Cognitive Impairment. Baik, JS., Min, JH., Ko, SH., et al.[2023]

Computerized cognitive training (CCT) shows moderate efficacy in improving overall cognition and specific cognitive domains in older adults with mild cognitive impairment, based on a review of 17 trials.

In individuals with dementia, CCT has limited evidence of efficacy, primarily influenced by a few trials using immersive technologies like virtual reality, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerized Cognitive Training in Older Adults With Mild Cognitive Impairment or Dementia: A Systematic Review and Meta-Analysis. Hill, NT., Mowszowski, L., Naismith, SL., et al.[2022]

Cognitive training intervention (CTI) significantly improved global cognitive function in healthy elderly participants after 12 weeks, with a mean difference score of 0.57 compared to a wait-list group, indicating its efficacy.

However, there was no lasting carry-over effect observed at 24 weeks, suggesting that while CTI can provide short-term benefits, its effects may not be sustained over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Cognitive Training in Healthy Community Residing Thai Elderly: A Randomized Controlled Trial. Phanasathit, M., Nimnuan, C., Lohsoonthorn, V.[2023]

Computer-assisted cognitive training has been shown to be an effective tool in neurological rehabilitation, particularly for patients with attention deficits, as it allows for precise stimulus representation and reaction time measures.

This type of training is most beneficial when integrated into a comprehensive therapeutic framework, enhancing the overall rehabilitation process and ensuring sufficient therapeutic intensity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Computer-assisted neuropsychological training in neurological rehabilitation]. Reuter, BM., Schönle, PW.[2006]

In a preliminary study involving 13 elderly patients with mild cognitive impairment (MCI), the combination of cognitive training and neurofeedback significantly improved working memory after four weeks of treatment.

The neurofeedback technique, which monitored brain activity in the left dorsolateral prefrontal cortex, showed that decreased brain activity correlated with better cognitive performance, suggesting a potential mechanism for enhancing cognitive function in MCI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive training based on functional near-infrared spectroscopy neurofeedback for the elderly with mild cognitive impairment: a preliminary study. Lee, I., Kim, D., Kim, S., et al.[2023]

Cognitive training (CT) was found to be feasible and acceptable for both healthy older adults and individuals with mild cognitive impairment (MCI) or dementia, with 37 participants providing positive feedback after 12 weeks of training.

Participants reported several benefits from CT, including enjoyment and improved cognitive awareness, but also faced barriers such as technology issues and emotional challenges, particularly those with dementia, highlighting the need for tailored approaches in future implementations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative Analysis of the Cognition and Flow (CoGFlowS) Study: An Individualized Approach to Cognitive Training for Dementia Is Needed. Beishon, L., Haunton, V., Subramaniam, H., et al.[2021]

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]

Computerized cognitive training (CCT) has been shown to provide a significant but small improvement in global cognitive function in patients with mild cognitive impairment (MCI), based on a systematic review of 18 studies involving 1059 participants.

While CCT also led to marginal improvements in specific cognitive domains, the overall effect size was modest, indicating the need for larger and longer-term studies to better understand its efficacy and potential recommendations for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Computerized Cognitive Training in Delaying Cognitive Function Decline in People With Mild Cognitive Impairment: Systematic Review and Meta-analysis. Li, R., Geng, J., Yang, R., et al.[2022]

Home-based Computerized Cognitive Training (CCT) tailored to individual needs significantly improved cognitive functions such as memory and learning in older adults with mild cognitive impairment (MCI) and mood-related neuropsychiatric symptoms (MrNPS) over an 8-12 week period.

Participants in the CCT group not only showed enhanced cognitive performance but also reported improved mood and reduced caregiver burden compared to those in the active control group, indicating broader benefits beyond just cognitive outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tailored and Adaptive Computerized Cognitive Training in Older Adults at Risk for Dementia: A Randomized Controlled Trial. Bahar-Fuchs, A., Webb, S., Bartsch, L., et al.[2022]

Citations

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Computerized cognitive training for memory functions in ... Among 1489 participants with MCI, CCT showed improvements in verbal memory (SMD (95%CI) = 0.55 (0.35–0.74)), visual memory (0.36 (0.12–0.60)), ...

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Individualised computerised cognitive training (iCCT) for ... By using a multi-tasking CCT three times a week for 30 min, people with MCI living at home can significantly improve their cognitive abilities within 6 months.

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Effectiveness of cognitive stimulation for individuals with ... Our findings suggest a significant positive impact of CS on cognitive function among individuals with MCI. CS encourages the active involvement of individuals ...

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Advancing Computerized Cognitive Training for MCI and ... The FDA guidance categorizes early AD into three stages—Stage 1 (pathological changes but no clinical deficits), Stage 2 (mild cognitive ...

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Effects of computerized cognitive training on structure ... Computerized cognitive training (CCT) has been demonstrated to be a safe and effective means of improving neurocognitive functions [15]. A few ...

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Intervention of computer-assisted cognitive training ... Computerized cognitive training combined with occupational therapy can improve patients' cognitive status, enhance their compliance with continuing care.

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Comparative efficacy of cognitive training modalities in ... Cognitive training is a widely utilized non-pharmacological intervention to enhance cognitive performance in individuals with cognitive impairment. Despite its ...