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Behavioral Intervention
Resilience Training for Age-related Cognitive Decline (MEDEX-2 Trial)
N/A
Waitlist Available
Led By Eric J Lenze, MD
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately three years
Awards & highlights
MEDEX-2 Trial Summary
This trial will study how stress affects cognitive function and emotional health in later life, including measures of Alzheimer Disease risk, stress, and aging.
Who is the study for?
This trial is for older adults who were part of a previous study (Protocol ID #201410093). They should be able to safely continue with classes and assessments. The focus is on those experiencing cognitive decline or stress related to the COVID-19 pandemic.Check my eligibility
What is being tested?
The study tests how health education, mindfulness-based stress reduction, exercise, and a combination of mindfulness plus exercise can impact brain health and resilience during the pandemic among older adults.See study design
What are the potential side effects?
While not explicitly listed, typical side effects from these interventions might include muscle soreness from exercise or temporary emotional discomfort when engaging in mindfulness practices.
MEDEX-2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately three years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately three years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Effects of the interventions on changes in cognitive performance
MEDEX-2 Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness-Based Stress Reduction + ExerciseExperimental Treatment1 Intervention
This condition will receive both MBSR and exercise as described. Participants in this condition will attend monthly sessions with encouragement to complete at-home mindfulness practice as well as at-home exercise for the duration of the study.
Group II: Mindfulness-Based Stress ReductionExperimental Treatment1 Intervention
Mindfulness-Based Stress Reduction (MBSR) as delivered in the parent study (Protocol ID #201410093) consisted of a brief introductory meeting, eight weekly 2.5-hour classes, and a retreat, followed by monthly booster sessions for approximately 15 months. Content included instruction in mindfulness meditation practices, gentle mindful movement, and exercises to enhance mindfulness in everyday life. For the current study, participants will continue monthly approximately 2.5 hour booster sessions covering similar content for the duration of the study. Participants will be encouraged to maintain daily formal meditative activities at home.
Group III: ExerciseExperimental Treatment1 Intervention
The exercise protocol in the parent study (Protocol ID #201410093) was optimal for improving aerobic fitness and insulin sensitivity in older adults, as well as improving strength and balance and reducing indices of frailty. It consisted of classes twice weekly for 6 months, building up to 1.5 hr, under the direct supervision of trained exercise instructors, followed by once weekly classes for 12 months. For the current study, participants will continue monthly approximately 1.5 hour classes focused on functional training for the duration of the study. Participants will be encouraged to continue between-session engagement in aerobic and resistance training activities at home.
Group IV: Health EducationActive Control1 Intervention
The health education control condition is based on a chronic disease self-management program developed at Stanford University and was used as an attentional control in the parent study (Protocol ID #201410093). This control intervention was designed to be time-equivalent to MBSR, with 8 weeks of 2.5 hour weekly group classes followed by monthly booster sessions for approximately 15 months. For the current study, participants will continue monthly approximately 1.5 hour sessions covering similar content for the duration of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness-Based Stress Reduction
2015
Completed Phase 4
~1880
Exercise
2016
Completed Phase 1
~760
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Who is running the clinical trial?
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,120 Total Patients Enrolled
1 Trials studying Age-related Cognitive Decline
585 Patients Enrolled for Age-related Cognitive Decline
National Institute on Aging (NIA)NIH
1,668 Previous Clinical Trials
28,004,596 Total Patients Enrolled
4 Trials studying Age-related Cognitive Decline
9,637 Patients Enrolled for Age-related Cognitive Decline
Washington University School of MedicineLead Sponsor
1,931 Previous Clinical Trials
2,299,241 Total Patients Enrolled
2 Trials studying Age-related Cognitive Decline
714 Patients Enrolled for Age-related Cognitive Decline
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Exercise
- Group 2: Health Education
- Group 3: Mindfulness-Based Stress Reduction
- Group 4: Mindfulness-Based Stress Reduction + Exercise
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies left for potential participants in this experiment?
"According to clinicaltrials.gov, the recruitment for this medical trial has ended as of August 31st 2022; it first appeared on December 6th 2021. Despite no longer looking for candidates, there are still 1,597 other studies that require patients at present time."
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