Cognitive Training for Mild Cognitive Impairment

(COGIT-2 Trial)

Recruiting at 1 trial location

Overseen By Cileyn Herrera, BA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Columbia University

Must not be taking: Benzodiazepines, Narcotics, Anticholinergics, others

Disqualifiers: Dementia, Schizophrenia, Bipolar, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 32

Duration: 12 weeks

240 Participants Needed

Trial Summary

What is the purpose of this trial?

Effective, clinically meaningful treatments are lacking for patients with mild cognitive impairment (MCI), which is associated with increased risk of transition to dementia. Cognitive training represents an important therapeutic strategy. In a previous study, crossword puzzles were found to be superior to computerized cognitive training on the primary cognitive outcome and function with decreased brain atrophy. Building on these findings, this study will evaluate and compare the impact of high dose crosswords (4 puzzles per week) to low dose crosswords (1 puzzle per week) and a health education control group on the cognition and function of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using certain medications that negatively impact cognition, like high doses of benzodiazepines, narcotics, or anticholinergics. If you are taking medications with anticholinergic or antihistaminergic properties, they will be reviewed to determine eligibility.

What data supports the effectiveness of this treatment 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 and varies across different groups and cognitive areas. ^{1 2 3 4 5}

Is cognitive training safe for humans?

Research suggests that computerized cognitive training is generally safe for older adults, including those with mild cognitive impairment or dementia. ^{3 4 6 7 8}

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 focuses on enhancing brain function directly. ^{1 2 3 9 10}

Eligibility Criteria

This trial is for people aged 55-89 with mild cognitive impairment (MCI), who have an informant to report on their functioning, access to a computer or tablet with internet, and can read English at a 6th-grade level. Women must be post-menopausal. Participants need documented memory impairment but still score above a certain threshold on a cognitive assessment.

Inclusion Criteria

Access to a home desktop or laptop computer or tablet at acceptable internet speed for the study duration

Must be English-speaking: Wide Range Achievement Test (WRAT3) score must indicate at least a 6th grade reading level with a score of ≥ 37

I am between 55 and 89 years old.

Exclusion Criteria

Current or recent alcohol or substance use disorder

Acute, severe unstable medical illness in the judgment of the clinician

Contraindication to MRI scan

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cognitive training with crosswords or health education for 12 weeks

12 weeks

In-person assessments at weeks 0 and 12

Booster Sessions

Participants receive booster sessions of cognitive training or health education at specified intervals

66 weeks

In-person assessments at weeks 32, 52, and 78; home sessions at weeks 20, 42, and 64

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cognitive Training

Trial Overview The COGIT-2 Trial is testing the effects of high dose crossword puzzles (4 per week) versus low dose crosswords (1 per week) and health education on cognition in MCI patients. It aims to see if more frequent puzzle-solving helps maintain or improve brain function compared to less frequent solving or just learning about health.

Participant Groups

Group I: Low Dose Crossword Active Control 1 Intervention

This sample will receive low dose crossword training with one crossword puzzle per week during the first 12 weeks on the Cognifit web-based platform. Subsequent booster sessions will occur at 20, 32, 42, 52, 64 and 78 weeks.

Group II: High Dose Crossword Active Control 1 Intervention

This sample will receive high dose crossword training. This sample will receive high dose crossword training with four crossword puzzles per week during the first 12 weeks on the Cognifit web-based platform, followed by booster sessions at 20, 32, 42, 52, 64 and 78 weeks.

Group III: Control Placebo Group 1 Intervention

This sample will receive health education. The participant will read chapters from the book, "Living a Healthy Life with chronic conditions," 5th edition, by K Lorig, D Laurent, V Gonzalez, D Sobel, M Minor and M Gecht-Silver, and review chapters with the unblinded study coordinator.

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

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]

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 (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]

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 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 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]

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 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. 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]

5. 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]

6. 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]

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

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

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]