NCT06792877 Mindfulness for Cognition in Early-stage Alzheimer's Disease
| NCT ID | NCT06792877 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Boston Healthcare System |
| Condition | Mild Cognitive Impairment (MCI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-01-23 |
| Primary Completion | 2027-01-01 |
Trial Parameters
Eligibility Fast-Check
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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.
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