240 Participants Needed

Cognitive Training for Mild Cognitive Impairment

(COGIT-2 Trial)

Recruiting at 4 trial locations
CH
DP
CH
LN
Overseen ByLola Nedic, BA
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

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.13678

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
See 5 more

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
See 9 more

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?
3Treatment groups
Active Control
Placebo Group
Group I: Low Dose CrosswordActive Control1 Intervention
Group II: High Dose CrosswordActive Control1 Intervention
Group III: ControlPlacebo Group1 Intervention

Find a Clinic Near You

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.
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.
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.
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]

Citations

Crossword puzzle training and neuroplasticity in mild ...Endpoint reductions in hippocampal volume and cortical thickness were smaller with crosswords than with computerized cognitive training.
Study Details | NCT06601933 | Cognitive Training and ...In a previous study, crossword puzzles were found to be superior to computerized cognitive training on the primary cognitive outcome and function with decreased ...
Study Shows Crossword Puzzles Beat Computer Games in ...Crossword puzzles showed an advantage over digital brain games in sharpening memory among older adults with mild cognitive impairment, according to a study in ...
4.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40852373/
Crossword puzzle training and neuroplasticity in mild ...The COGIT-2 trial is a 78-week study comparing high and low-dose crossword puzzles to a control group in MCI subjects, with potential for a low-cost cognitive ...
Cognitive Training and Neuroplasticity in Mild ...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 ...
Study Details | NCT06601933 | Cognitive Training and ...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 ...
Computerized Games versus Crosswords Training in Mild ...We compared the efficacy of computerized training with Web-based cognitive games with computerized training with crossword puzzles among adults ...
Impact of Computerized Cognitive Training on Default ...The goal of this study was to examine the effect of CCT versus a non-targeted active brain exercise on functional cognitive networks.
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