Mindfulness for Cognition in Early-stage Alzheimer's Disease

January 23, 2025 updated by: Katherine Turk, VA Boston Healthcare System

Mechanisms of Mindfulness for Cognition in Early-Stage Alzheimer's Disease

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02130
        • Recruiting
        • VA Boston Healthcare System - Jamaica Plain Campus
        • Contact:
        • Contact:
          • Katherine W Turk, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness
MBSR course of mindfulness using focused attention, body scan practice and light chair yoga.
Behavioral: Mindfulness Intervention
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.
Other Names:
  • Meditation
  • Mindfulness-Based Stress Reduction
Behavioral: Waitlist then mindfulness
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From before the intervention (baseline) to after the intervention (post-intervention 10 weeks)
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
From before the intervention (baseline) to after the intervention (post-intervention 10 weeks)
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
From before the intervention (baseline) to after the intervention (post-intervention 10 weeks)
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.
From before the intervention (baseline) to after the intervention (post-intervention 10 weeks))
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
From before the intervention (baseline) to after the intervention (post-intervention 10 weeks))

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Boston Healthcare System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

January 14, 2025

First Submitted That Met QC Criteria

January 23, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 23, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1796795

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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