Mindfulness for Cognition in Early-stage Alzheimer's Disease

NCT06792877 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-01-27

No results posted yet for this study

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:

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.

Conditions

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

Interventions

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.

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.

Sponsors & Collaborators

  • VA Boston Healthcare System

    lead FED

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-23
Primary Completion
2027-01-01
Completion
2027-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06792877 on ClinicalTrials.gov