Mindfulness for Cognition in Early-stage Alzheimer's Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-100
SponsorVA Boston Healthcare System

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mindfulness Intervention

    Behavioral

    The Mindfulness Intervention is an adapted form of Mindfulness-based stress reduction (MBSR) training virtual class that meets for 10 weeks. The class involves mindfulness training using awareness and focused attention, group discussion of the experience, and mindful movement. The Mindfulness Intervention also includes daily home practice using mindfulness recordings.

  • Waitlist then mindfulness

    Behavioral

    Participants in this arm will first wait 10 weeks and then complete a mindfulness course with outcome measures assessed at baseline, after 10 weeks wait list and then after mindfulness course.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: MindfulnessExperimental treatment 2 interventions
Group B: Mindfulness WaitlistNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Neuropsychological tests

Paper-and-pencil tests measuring attention, processing speed, and memory.

Time frame
From before the intervention (baseline) to after the intervention (post-intervention 10 weeks)
2

Performance on computerized tasks

Reaction time and accuracy on computer tasks measuring attention and memory

Time frame
From before the intervention (baseline) to after the intervention (post-intervention 10 weeks)
3

Resting state and event-related electrophysiology

Electrophysiology measured while at rest and time-locked to performance on a computerized task measuring attention and memory

Time frame
From before the intervention (baseline) to after the intervention (post-intervention 10 weeks)
4

Brain function and structure

Blood-oxygen-level-dependent (BOLD) for functional magnetic resonance imaging. Voxel-based morphometry (VBM) and diffusion tensor imaging (DTI) for structural magnetic resonance imaging.

Time frame
From before the intervention (baseline) to after the intervention (post-intervention 10 weeks))

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.