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

Trial Summary

What is the purpose of this trial?

Older adults at risk for dementia show a variety of cognitive deficits, which can be ameliorated by different cognitive training (CT) exercises. The best combination of CT exercises is unknown. The aim is to discover the most efficacious combination of CT exercises as compared to cognitive stimulation (which will serve as a stringent, active control) to modify the functional trajectories of older adults' with MCI, who are at high risk for dementia. The primary objective of the U01 phase was to design and pilot-test an adaptive, randomized clinical trial (RCT) of cognitive training (CT) combinations aimed to enhance performance of instrumental activities of daily living (IADL) among persons with mild cognitive impairment (MCI). In the R01 phase, the objective is to identify the best combination of CT exercises to delay dementia onset among persons with MCI. The longitudinal endpoint goal is reducing incident dementia. The primary aim of the study is to determine which CT combination has the best probability to delay dementia by producing the largest IADL improvements. The study further aims to explore neuroimaging and novel blood-based biomarkers.

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 data supports the effectiveness of the treatment Cognitive Training for Mild Cognitive Impairment?

Research shows that computerized cognitive training can improve cognitive function in older adults with mild cognitive impairment, although the evidence is still limited. It has been used successfully in neurological rehabilitation, particularly for attention deficits, and is considered a valuable tool when integrated into a broader therapeutic plan. ^{1 2 3 4 5}

Is cognitive training safe for people with mild cognitive impairment?

Research indicates that computerized cognitive training is generally safe for older adults, including those with mild cognitive impairment. ^{3 6 7 8 9}

How is Cognitive Training different from other treatments for mild cognitive impairment?

Cognitive Training is unique because it uses computer-based exercises to target specific brain functions and improve cognitive abilities through neuroplasticity (the brain's ability to reorganize itself). Unlike medications, which have generally not been successful for mild cognitive impairment, this approach leverages the brain's natural capacity to adapt and change. ^{1 2 3 5 10}

Research Team

Jerri Edwards, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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) 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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Tailored and Adaptive Computerized Cognitive Training in Older Adults at Risk for Dementia: A Randomized Controlled Trial. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

[Computer-assisted neuropsychological training in neurological rehabilitation]. [2006]

3. Canada 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. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Qualitative Analysis of the Cognition and Flow (CoGFlowS) Study: An Individualized Approach to Cognitive Training for Dementia Is Needed. [2021]

5. England 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. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Computerized Cognitive Training in Older Adults With Mild Cognitive Impairment or Dementia: A Systematic Review and Meta-Analysis. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Cognitive training based on functional near-infrared spectroscopy neurofeedback for the elderly with mild cognitive impairment: a preliminary study. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of Home-Based Computerized Cognitive Training in Community-Dwelling Adults With Mild Cognitive Impairment. [2023]

9. New Zealand pubmed.ncbi.nlm.nih.gov

The Effects of Cognitive Training in Healthy Community Residing Thai Elderly: A Randomized Controlled Trial. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

A Comparative Single-Blind Randomized Controlled Trial With Language Training in People With Mild Cognitive Impairment. [2020]