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Mindfulness for Cognition in Early-stage Alzheimer's Disease

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06792877
Enrollment
100
Registered
2025-01-27
Start date
2025-01-23
Completion date
2027-03-31
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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)

Keywords

Mindfulness, Aging, Mild Cognitive Impairment (MCI), Cognition, Memory, Alzheimers Disease, Social Group

Brief 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.

Interventions

BEHAVIORALMindfulness 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.

BEHAVIORALWaitlist 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

VA Boston Healthcare System
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 100 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Neuropsychological testsFrom before the intervention (baseline) to after the intervention (post-intervention 10 weeks)Paper-and-pencil tests measuring attention, processing speed, and memory.
Performance on computerized tasksFrom before the intervention (baseline) to after the intervention (post-intervention 10 weeks)Reaction time and accuracy on computer tasks measuring attention and memory
Resting state and event-related electrophysiologyFrom 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
Brain function and structureFrom 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.
Survey outcomesFrom before the intervention (baseline) to after the intervention (post-intervention 10 weeks))Surveys measuring mood, social isolation, sleep, and quality of life

Countries

United States

Contacts

Primary ContactKatherine W Turk, MD
ctcnbrainlab@gmail.com8573645429
Backup ContactKathy Y Xie, PhD
ctcnbrainlab@gmail.com8572300905

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026