Clinical trial NCT06792877: Mindfulness for Cognition in Early-stage Alzheimer's Disease
Official title: Mechanisms of Mindfulness for Cognition in Early-Stage Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment (MCI)
Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease
TBI (Traumatic Brain Injury)
Aging
Healthy Elderly
Alzheimer&Amp;Amp;#39;s Dementia (AD)
Keywords: Mindfulness
Aging
Mild Cognitive Impairment (MCI)
Cognition
Memory
Alzheimers Disease
Social Group
Lead sponsor: VA Boston Healthcare System
Sponsor class: FED
First posted: 2025-01-27
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Primary outcomes:
measure: Neuropsychological tests
timeFrame: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks)
measure: Performance on computerized tasks
timeFrame: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks)
measure: Resting state and event-related electrophysiology
timeFrame: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks)
measure: Brain function and structure
timeFrame: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks))
measure: Survey outcomes
timeFrame: From before the intervention (baseline) to after the intervention (post-intervention 10 weeks))
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System - Jamaica Plain Campus
state: Massachusetts
Study officials:
References: