Abstract
BackgroundAmnestic mild cognitive impairment (aMCI) is considered a risk state for the development of dementia due to Alzheimer’s disease. It is also a period in which interventions may be most effective in slowing progression to dementia. Computerized cognitive training and increased physical activity have shown to be among the most promising interventions. However, current evidence from randomized controlled trials comparing cognitive training, physical activity, and an active control is inconsistent. Furthermore, the neural mechanisms underlying these interventions are currently unclear.MethodsThe objective of the current pilot study is to explore the feasibility of a trial investigating the impact of computerized cognitive training, yoga, and an active control intervention (wellness education) in individuals with aMCI by conducting a group-randomized, multisite, parallel, three-arm pilot study. We will establish preliminary effect sizes regarding the association of each intervention with neuroimaging and cognitive and participant-reported measures. We also aim to estimate the strength of association between the various outcomes. The current trial aims to recruit 75 people with aMCI and their 75 cognitively healthy care partners through clinics and senior care facilities. The initial intervention will last 10 days and will consist of 1 h daily of the assigned intervention i.e., (yoga, computerized cognitive training, or wellness education) combined with 1 h of memory compensation training and 1 h of support groups. Twenty-five participants will be group-randomized to each arm using a random number generator. Study staff and participants will be kept blind until recruitment is complete for each group. After the initial two-week intervention, participants will continue the assigned intervention for 24 weeks. Outcome measures are: functional connectivity and cerebral perfusion as assessed by magnetic resonance imaging; cognition; daily functioning; mood; anxiety; self-efficacy; caregiver burden; quality of life; and study feasibility including recruitment and retention rates.DiscussionThis pilot trial aims to investigate the feasibility of a trial studying the impact of computerized cognitive training, yoga, and an active control intervention in persons with aMCI on MRI-based functional connectivity and cerebral perfusion as well as cognition, daily functioning, mood, anxiety, and quality of life and feasibility?Trial registrationsClinicalTrials.gov, NCT03095170. Registered on 23 March 2017.
Highlights
Amnestic mild cognitive impairment is considered a risk state for the development of dementia due to Alzheimer’s disease
The PEACEOFMND trial will investigate the impact of computerized cognitive training versus yoga versus an active control group on functional connectivity and cerebral perfusion in the brain as well as on cognitive functions, daily functioning, mood, anxiety, self-efficacy, caregiver burden, and quality of life
The study partners will be asked to fill out the Treatment Diffusion Log about the person with Amnestic mild cognitive impairment (aMCI)’s and their own time spent on any type of physical exercise, computerized cognitive training, wellness behaviors, use of a calendar, and supportive therapy
Summary
Setting Potential trial participants will be recruited from the Memory Disorder Clinics, behavioral neurology and neuropsychology practices at the University of Florida, Mayo Clinic Jacksonville, and Tallahassee Memorial Hospital. The study partners will be asked to fill out the Treatment Diffusion Log about the person with aMCI’s and their own time spent on any type of physical exercise, computerized cognitive training, wellness behaviors, use of a calendar, and supportive therapy. This will be done to assess specific skills targeted by the interventions. Confidentiality Only the PI and Sub-Investigators that are approved by any of the three IRBs (of the University of Florida, Mayo Jacksonville, and Tallahassee Memorial Healthcare), other professionals at the study site that provide trial-related treatment or procedures, and the three IRBs are allowed to collect, use, and share protected health information. If any questions arise regarding the data, the protocol, and the statistical codes, any of the PIs may be contacted
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