NCT06792877 · VA Boston Healthcare System
Mindfulness for Cognition in Early-stage Alzheimer's Disease
What this study is about
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.
View original scientific description
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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 27, 2025 · Source of record for eligibility and locations