Cognitive Training for Mild Cognitive Impairment

(COGIT-2 Trial)

Recruiting at 4 trial locations

Overseen By Lola Nedic, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how varying amounts of crossword puzzle activities might help people with mild cognitive impairment (MCI) enhance their memory and thinking skills through Cognitive Training (also known as Computerized Cognitive Training or Brain Training). Researchers will compare the effects of completing four crossword puzzles per week, one crossword puzzle per week, and participating in health education. This trial suits individuals who notice memory or thinking challenges and have access to a computer or tablet with internet. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to early-stage findings.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that doing crosswords is generally safe and easy to handle. Past studies have demonstrated that crossword puzzles improve thinking skills in older adults with mild memory problems, without causing any adverse side effects. This holds true for both frequent and occasional crossword puzzle practice. No evidence suggests that doing crosswords leads to negative effects. Participants solve puzzles online, which has been shown to sharpen memory. This type of training is non-invasive, meaning it doesn't involve surgery or entering the body, and is considered low-risk. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these cognitive training techniques because they offer a novel, non-pharmacological approach to managing mild cognitive impairment. Unlike standard treatments that often involve medications to manage symptoms, these methods focus on actively engaging the brain. The use of web-based crossword training, especially in varying doses, aims to enhance cognitive function through mental exercises, potentially strengthening brain health without the side effects associated with drugs. This personalized, interactive approach could lead to a more sustainable and enjoyable way to maintain cognitive abilities over time.

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

An earlier study found that doing crossword puzzles was more effective than using computer programs for improving memory and thinking skills in people with mild cognitive impairment (MCI). This was linked to less brain shrinkage, particularly in areas crucial for memory. In this trial, participants will be assigned to different groups to evaluate the effects of crossword training. The study examines both low-dose (one puzzle per week) and high-dose (four puzzles per week) crossword training to determine if doing more puzzles each week might have a stronger effect. Early results suggest that crossword puzzles could be a simple and effective way to enhance brain health in individuals at risk for dementia. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

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

Montreal Cognitive Assessment (MoCA) score ≥ 20/30

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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The goal of this study was to examine the effect of CCT versus a non-targeted active brain exercise on functional cognitive networks.