Mechanisms of Mindfulness for Cognition in Early-Stage Alzheimer's Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- VA Boston Healthcare System
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Performance on computerized tasks
Study Overview
Brief Summary
The goal of this clinical trial is to learn if mindfulness meditation can improve outcomes in older adults with and without cognitive impairment. The main questions it aims to answer are:
- How does mindfulness impact thinking and memory?
- How does mindfulness influence brain function and structure?
- How does mindfulness affect daily function and quality of life?
Researchers will compare all outcomes to one other groups. In one group, individuals will participate in a mindfulness class intervention; in the other group, individuals will not engage in any active interventions immediately, but will be placed on a waitlist for the mindfulness intervention. Researchers will compare all outcomes between the groups groups to determine whether the mindfulness interventions leads to greater improvement compared to no intervention (waitlist group).
Participants will:
- Be randomly assigned to participate in the mindfulness intervention, or no immediate intervention (waitlist)
- Complete paper-and-pencil cognitive testing, surveys, computerized tasks, and neuroimaging measures (EEG and MRI) before and after the intervention
Outcomes will be assess at baseline, 2 months, 4 months and 6 months.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy older adults will show cognitive performance within 1.0 SD for age & education adjusted norms on a neuropsychological test battery
- •Mild cognitive impairment (MCI) participants will show performance on delayed recall or one more or more other cognitive domains worse than 1.5 SD for age & education adjusted norms, an MMSE score between 25-30, and a MoCA score between 20-30.
Exclusion Criteria
- •Participants without a computer, smart phone and internet access will be excluded
- •If they cannot understand the informed consent form or have moderate dementia.
- •Mood disorders (e.g., PTSD, depression, anxiety) or alcohol and drug use that either interferes with day-to-day life or required hospitalization within the past 5 years
- •Cerebrovascular disease
- •Any medical condition whose severity could significantly impair cognition (e.g., stroke, frontotermporal dementia, Parkinson's disease) are exclusionary
Arms & Interventions
Mindfulness
MBSR course of mindfulness using focused attention, body scan practice and light chair yoga.
Intervention: Mindfulness Intervention (Behavioral)
Mindfulness
MBSR course of mindfulness using focused attention, body scan practice and light chair yoga.
Intervention: Waitlist then mindfulness (Behavioral)
Mindfulness Waitlist
Individuals in the Mindfulness Waitlist group will not engage in any of the study interventions until 2 months has passed. Then they will be enrolled in the Mindfulness Intervention.
Outcomes
Primary Outcomes
Performance on computerized tasks
Time Frame: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks)
Reaction time and accuracy on computer tasks measuring attention and memory
Resting state and event-related electrophysiology
Time Frame: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks)
Electrophysiology measured while at rest and time-locked to performance on a computerized task measuring attention and memory
Survey outcomes
Time Frame: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks))
Surveys measuring mood, social isolation, sleep, and quality of life
Neuropsychological tests
Time Frame: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks)
Paper-and-pencil tests measuring attention, processing speed, and memory.
Brain function and structure
Time Frame: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks))
Blood-oxygen-level-dependent (BOLD) for functional magnetic resonance imaging. Voxel-based morphometry (VBM) and diffusion tensor imaging (DTI) for structural magnetic resonance imaging.
Secondary Outcomes
No secondary outcomes reported
Investigators
Katherine Turk
Behavioral Neurologist at VA Boston Memory Disorders Clinic; Assistant Professor of Neurology at Boston University Chobanian & Avedisian School of Medicine
VA Boston Healthcare System