Mindfulness for Cognition in Early-stage Alzheimer's Disease

Veterans Affairs (VA) Boston Healthcare System

Status: Enrolling

Conditions: Aging; Mild Cognitive Impairment (MCI); Alzheimer's Dementia (AD); Healthy Elderly; Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease; TBI (Traumatic Brain Injury)

Treatments: Behavioral: Waitlist then mindfulness; Behavioral: Mindfulness Intervention

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT06792877

1796795

Details and patient eligibility

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. 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 50 to 100 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Mindfulness

Experimental group

Description:

MBSR course of mindfulness using focused attention, body scan practice and light chair yoga.

Treatment:

Behavioral: Mindfulness Intervention

Behavioral: Waitlist then mindfulness

Mindfulness Waitlist

No Intervention group

Description:

Individuals in the Mindfulness Waitlist group will not engage in any of the study interventions until 2 months has passed. Then they will be enrolled in the Mindfulness Intervention.