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Recruiting NCT06792877

Mindfulness for Cognition in Early-stage Alzheimer's Disease

No phase Interventional Mild Cognitive Impairment (MCI) Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease TBI (Traumatic Brain Injury) Aging

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mindfulness Intervention, Waitlist then mindfulness.
Who it may be relevant to
Registry conditions: Mild Cognitive Impairment (MCI), Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease, TBI (Traumatic Brain Injury), Aging. Basic parameters: 50 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • 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.

Primary outcome measures

  • Neuropsychological tests [Time frame: 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)]
  • Resting state and event-related electrophysiology [Time frame: 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))]
  • Survey outcomes [Time frame: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks))]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • VA Boston Healthcare System - Jamaica Plain Campus — Boston

Identifiers

NCT: NCT06792877 · 1796795

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗