Mindfulness for Cognition in Early-stage Alzheimer's Disease
Mechanisms of Mindfulness for Cognition in Early-Stage Alzheimer's Disease
1 other identifier
interventional
100
1 country
1
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:
- 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2025
CompletedStudy Start
First participant enrolled
January 23, 2025
CompletedFirst Posted
Study publicly available on registry
January 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
January 27, 2025
January 1, 2025
1.9 years
January 14, 2025
January 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Neuropsychological tests
Paper-and-pencil tests measuring attention, processing speed, and memory.
From before the intervention (baseline) to after the intervention (post-intervention 10 weeks)
Performance on computerized tasks
Reaction time and accuracy on computer tasks measuring attention and memory
From before the intervention (baseline) to after the intervention (post-intervention 10 weeks)
Resting state and event-related electrophysiology
Electrophysiology measured while at rest and time-locked to performance on a computerized task measuring attention and memory
From before the intervention (baseline) to after the intervention (post-intervention 10 weeks)
Brain function and structure
Blood-oxygen-level-dependent (BOLD) for functional magnetic resonance imaging. Voxel-based morphometry (VBM) and diffusion tensor imaging (DTI) for structural magnetic resonance imaging.
From before the intervention (baseline) to after the intervention (post-intervention 10 weeks))
Survey outcomes
Surveys measuring mood, social isolation, sleep, and quality of life
From before the intervention (baseline) to after the intervention (post-intervention 10 weeks))
Study Arms (2)
Mindfulness
EXPERIMENTALMBSR course of mindfulness using focused attention, body scan practice and light chair yoga.
Mindfulness Waitlist
NO INTERVENTIONIndividuals 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.
Interventions
The Mindfulness Intervention is an adapted form of Mindfulness-based stress reduction (MBSR) training virtual class that meets for 10 weeks. The class involves mindfulness training using awareness and focused attention, group discussion of the experience, and mindful movement. The Mindfulness Intervention also includes daily home practice using mindfulness recordings.
Participants in this arm will first wait 10 weeks and then complete a mindfulness course with outcome measures assessed at baseline, after 10 weeks wait list and then after mindfulness course.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Boston Healthcare System - Jamaica Plain Campus
Boston, Massachusetts, 02130, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Behavioral Neurologist at VA Boston Memory Disorders Clinic; Assistant Professor of Neurology at Boston University Chobanian & Avedisian School of Medicine
Study Record Dates
First Submitted
January 14, 2025
First Posted
January 27, 2025
Study Start
January 23, 2025
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
March 31, 2027
Last Updated
January 27, 2025
Record last verified: 2025-01