Mindfulness for Cognition in Early-stage Alzheimer's Disease

NCT ID: NCT06792877

Last Updated: 2025-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-23

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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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)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Mindfulness

MBSR course of mindfulness using focused attention, body scan practice and light chair yoga.

Group Type EXPERIMENTAL

Mindfulness Intervention

Intervention Type 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

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Mindfulness-Based Stress Reduction Meditation

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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VA Boston Healthcare System

FED

Sponsor Role lead

Responsible Party

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Katherine Turk

Behavioral Neurologist at VA Boston Memory Disorders Clinic; Assistant Professor of Neurology at Boston University Chobanian & Avedisian School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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VA Boston Healthcare System - Jamaica Plain Campus

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Katherine W Turk, MD

Role: CONTACT

8573645429

Kathy Y Xie, PhD

Role: CONTACT

8572300905

Facility Contacts

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Kathy Xie, PhD

Role: primary

8573645429

Other Identifiers

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1796795

Identifier Type: -

Identifier Source: org_study_id

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