Cognitive Training for Mild Cognitive Impairment
Recruiting in Palo Alto (17 mi)
+4 other locations
Overseen byJerri Edwards, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Alabama at Birmingham
Disqualifiers: Dementia, Stroke, Parkinson's, others
No Placebo Group
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.
12345Is 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.
36789How 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.
123510Eligibility 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.
+7 more
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.
+15 more
Trial 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
Participant Groups
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.
5Treatment groups
Experimental Treatment
Active Control
Group I: CTacExperimental Treatment1 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: CTabcExperimental Treatment1 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: CTabExperimental Treatment1 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: CTaExperimental Treatment1 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 StimulationActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Clemson UniversitySeneca, SC
University of MinnesotaMinneapolis, MN
University of California San FranciscoSan Francisco, CA
University of FloridaGainesville, FL
More Trial Locations
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Who Is Running the Clinical Trial?
University of Alabama at BirminghamLead Sponsor
University of South FloridaLead Sponsor
University of FloridaCollaborator
University of California, San FranciscoCollaborator
University of MinnesotaCollaborator
National Institute on Aging (NIA)Collaborator
Clemson UniversityCollaborator
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.
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 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.
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.
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.
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.
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.
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.