Mindfulness for Cognition in Early-stage Alzheimer's Disease

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
VA Boston Healthcare System
Study ID
NCT06792877
Status
Recruiting
Apply to this trial

Conditions

  • Aging
  • Alzheimer&Amp;Amp;#39;s Dementia (AD)
  • Healthy Elderly
  • Mild Cognitive Impairment (MCI)
  • Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease
  • TBI (Traumatic Brain Injury)

Eligibility Criteria

Sex
ALL
Age
50 Years - 100 Years
Healthy Volunteers
Accepted

Interventions

  • Mindfulness Intervention — BEHAVIORAL
    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.
  • Waitlist then mindfulness — BEHAVIORAL
    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.

Study Details

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: 1. How does mindfulness impact thinking and memory? 2. How does mindfulness influence brain function and structure? 3. 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.

Key Dates

Start date
Jan 23, 2025
Status verified
Jan 2025
Primary completion
Jan 1, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Mindfulness
    MBSR course of mindfulness using focused attention, body scan practice and light chair yoga.
  • No Intervention: 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.

Primary Outcome Measure

Neuropsychological tests [ Time Frame: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Boston Healthcare System - Jamaica Plain CampusBostonMassachusetts02130
Kathy Xie, PhD
[email protected]
8573645429
Katherine W Turk, MD (PRINCIPAL_INVESTIGATOR)

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By research site
VA Boston Healthcare System - Jamaica Plain Campus· Boston, MA

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