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NCT Number: NCT06792877

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.

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Key information

Conditions

Mild Cognitive Impairment (MCI) Aging Alzheimer Disease Alzheimer&Amp;Amp;#39;s Dementia (AD) Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Craniocerebral Trauma Dementia Healthy Elderly Mental Disorders Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases TBI (Traumatic Brain Injury) Tauopathies Trauma, Nervous System Wounds and Injuries

Age range

50 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Boston Healthcare System - Jamaica Plain Campus

Boston, Massachusetts, 02130, United States

Location status: Recruiting

Location contact

Katherine W Turk, MD

PRINCIPAL_INVESTIGATOR

Kathy Xie, PhD

CONTACT

[email protected]

8573645429

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Mindfulness-Based Stress Reduction, Meditation

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.

Primary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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.

  5. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Katherine W Turk, MD

CONTACT

[email protected]

8573645429

Kathy Y Xie, PhD

CONTACT

[email protected]

8572300905

Sponsors and collaborators

Lead sponsor

VA Boston Healthcare System

Fed

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 27, 2025
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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