Mindfulness for Cognition in Early-stage Alzheimer's Disease

Not Applicable

Recruiting

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

• Registration Number: NCT06792877
• Lead Sponsor: VA Boston Healthcare System

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-14
• Study Start: 2025-01-23
• Study First Submitted QC: 2025-01-23
• Last Update Submitted: 2025-01-23
• Study First Posted: 2025-01-27
• Last Update Posted: 2025-01-27
• Primary Completion: 2027-01-01
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Neuropsychological tests	From before the intervention (baseline) to after the intervention (post-intervention 10 weeks)	Paper-and-pencil tests measuring attention, processing speed, and memory.
Performance on computerized tasks	From before the intervention (baseline) to after the intervention (post-intervention 10 weeks)	Reaction time and accuracy on computer tasks measuring attention and memory
Resting state and event-related electrophysiology	From before the intervention (baseline) to after the intervention (post-intervention 10 weeks)	Electrophysiology measured while at rest and time-locked to performance on a computerized task measuring attention and memory
Brain function and structure	From before the intervention (baseline) to after the intervention (post-intervention 10 weeks))	Blood-oxygen-level-dependent (BOLD) for functional magnetic resonance imaging. Voxel-based morphometry (VBM) and diffusion tensor imaging (DTI) for structural magnetic resonance imaging.
Survey outcomes	From before the intervention (baseline) to after the intervention (post-intervention 10 weeks))	Surveys measuring mood, social isolation, sleep, and quality of life

Trial Locations

Locations (1)

VA Boston Healthcare System - Jamaica Plain Campus; 🇺🇸 Boston, Massachusetts, United States