Mindfulness for Cognition in Early-stage Alzheimer's Disease (NCT06792877) | Clinical Trial Compass
RecruitingNot Applicable
Mindfulness for Cognition in Early-stage Alzheimer's Disease
United States100 participantsStarted 2025-01-23
Plain-language 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.
Who can participate
Age range
50 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is enrolling people with mild cognitive impairment, Alzheimer's disease, traumatic brain injury, and even healthy older adults — given my specific diagnosis, does my doctor think I'd fit into this study, and which group would I likely be placed in?
2Since this is a Phase NA mindfulness-based study rather than a drug trial, what does my doctor think about the evidence behind mindfulness as an approach for cognitive symptoms, and could it realistically complement or conflict with any treatments I'm already receiving?
3The study involves brain scans, EEG recordings, computerized tasks, and neuropsychological testing — how much of my time and energy would these visits realistically require, and is that manageable given where I am in my health right now?
4Because this trial is measuring brain function and structure alongside survey outcomes, does my doctor think participating could give us useful information about how my cognition is changing, even if it's primarily a research study and not a treatment?
5Would my doctor recommend I consider any standard-of-care options before or instead of joining this trial, or does the mindfulness focus here fill a gap that existing treatments don't address for someone in my situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Neuropsychological tests
Timeframe: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks)
2
Performance on computerized tasks
Timeframe: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks)
3
Resting state and event-related electrophysiology
Timeframe: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks)
4
Brain function and structure
Timeframe: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks))
5
Survey outcomes
Timeframe: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks))