Cognitive Training for Mild Cognitive Impairment
(COGIT-2 Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Columbia University
Must not be taking: Benzodiazepines, Narcotics, Anticholinergics, others
Disqualifiers: Dementia, Schizophrenia, Bipolar, others
Prior Safety Data
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.
12345Is 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.
34678How 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.
123910Eligibility 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.
+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
+9 more
Trial 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
Participant Groups
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.
3Treatment groups
Active Control
Placebo Group
Group I: Low Dose CrosswordActive Control1 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 CrosswordActive Control1 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: ControlPlacebo Group1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Columbia University Irving Medical CenterNew York, NY
Columbia University CRRNew York, NY
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Who Is Running the Clinical Trial?
Columbia UniversityLead Sponsor
National Institute on Aging (NIA)Collaborator
References
Tailored and Adaptive Computerized Cognitive Training in Older Adults at Risk for Dementia: A Randomized Controlled Trial. [2022]Computerized Cognitive Training (CCT) has been shown to improve cognitive function in older adults with mild cognitive impairment (MCI) or mood-related neuropsychiatric symptoms (MrNPS), but many questions remain unresolved.
[Computer-assisted neuropsychological training in neurological rehabilitation]. [2006]Using computer-assisted cognitive training to treat patients with cognitive disorders has proved a useful tool in neurological rehabilitation. This has been shown by positive experience in many rehabilitation clinics but also in numerous control studies investigating the efficiency of such training. Patients with attention deficits show the most pronounced improvements as the computer with its technical possibilities is an ideal training instrument because of stimulus representation and reaction time measures. In other areas, computer training has become an essential therapeutic means complementing other therapies. In a clinical environment it seems that computer training is essential because it enables attaining the necessary therapeutic density. However, training must be integrated and become part of a global therapeutic framework.
Effectiveness of Computerized Cognitive Training in Delaying Cognitive Function Decline in People With Mild Cognitive Impairment: Systematic Review and Meta-analysis. [2022]With no current cure for mild cognitive impairment (MCI), delaying its progression could significantly reduce the disease burden and improve the quality of life for patients with MCI. Computerized cognitive training (CCT) has recently become a potential instrument for improvement of cognition. However, the evidence for its effectiveness remains limited.
Computerized Cognitive Training in Older Adults With Mild Cognitive Impairment or Dementia: A Systematic Review and Meta-Analysis. [2022]Previous meta-analyses indicate that computerized cognitive training (CCT) is a safe and efficacious intervention for cognition in older adults. However, efficacy varies across populations and cognitive domains, and little is known about the efficacy of CCT in people with mild cognitive impairment or dementia.
Qualitative Analysis of the Cognition and Flow (CoGFlowS) Study: An Individualized Approach to Cognitive Training for Dementia Is Needed. [2021]Cognitive training (CT) may have benefits for both healthy older adults (HC) and those with early cognitive disorders [mild cognitive impairment (MCI) and dementia]. However, few studies have qualitatively evaluated home-based, computerized CT programs.
Cognitive training based on functional near-infrared spectroscopy neurofeedback for the elderly with mild cognitive impairment: a preliminary study. [2023]Mild cognitive impairment (MCI) is often described as an intermediate stage of the normal cognitive decline associated with aging and dementia. There is a growing interest in various non-pharmacological interventions for MCI to delay the onset and inhibit the progressive deterioration of daily life functions. Previous studies suggest that cognitive training (CT) contributes to the restoration of working memory and that the brain-computer-interface technique can be applied to elicit a more effective treatment response. However, these techniques have certain limitations. Thus, in this preliminary study, we applied the neurofeedback paradigm during CT to increase the working memory function of patients with MCI.
The Effects of Cognitive Training in Healthy Community Residing Thai Elderly: A Randomized Controlled Trial. [2023]Cognitive training intervention (CTI) is defined as any mechanism of action of a non-pharmacological procedure provided to improve cognitive function. CTI in healthy elderly has the potential to improve cognitive function; however, the effects of interactive computerized-CTI in old ages have been inconclusive. The present study aimed to determine the effects of low-technology CTI in community-based populations.
Effects of Home-Based Computerized Cognitive Training in Community-Dwelling Adults With Mild Cognitive Impairment. [2023]There is a growing importance for the home-based (HB) support services, and computerized cognitive training (CCT) has been reported as an effective intervention for cognitive impairment. However, there is still a need for further verification of the effect of HB-CCT. This study aimed to determine the effectiveness of HB-CCT on the cognitive function of community-dwelling adults with mild cognitive impairment (MCI) as well as safety in its use.
Cognitive training and neuroplasticity in mild cognitive impairment (COG-IT): protocol for a two-site, blinded, randomised, controlled treatment trial. [2020]Mild cognitive impairment (MCI) is common in older adults and represents a high-risk group for progression to Alzheimer's disease (AD). Medication trials in MCI have generally failed, but new discoveries with brain plasticity in ageing have led to the study of cognitive training as a potential treatment to improve cognitive abilities. Computerised cognitive training (CCT) involves computerised cognitive exercises that target specific cognitive abilities and neural networks to potentially improve cognitive functioning through neuroplasticity.
A Comparative Single-Blind Randomized Controlled Trial With Language Training in People With Mild Cognitive Impairment. [2020]Although cognitive training is effective for people with mild cognitive impairment (MCI), it is not clear which format is more effective.