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Lifestyle medicine for Alzheimer's Disease
N/A
Waitlist Available
Led By Dean Ornish, MD
Research Sponsored by Preventive Medicine Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline and also after 20 weeks, 40 weeks.
Awards & highlights
No Placebo-Only Group
Summary
This trial tests if making significant lifestyle changes can slow, stop, or reverse early-stage Alzheimer's disease. It involves patients adopting healthier habits like better diet, regular exercise, stress management, and social activities to improve brain health.
Eligible Conditions
- Alzheimer's Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline and also after 20 weeks, 40 weeks.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline and also after 20 weeks, 40 weeks.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from Baseline in Alzheimer Disease Assessment Scale cognitive section (ADAS-Cog) score
Change from Baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) score
Change from Baseline in Clinical Global Impression of Change (CGIC) score
Secondary study objectives
Amyloid peptides
Angiogenesis biomarkers
Changes from baseline in biomarkers
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental (Intervention) GroupExperimental Treatment1 Intervention
These patients will receive the comprehensive lifestyle medicine intervention from day 1 through the end of the study. They will be tested at baseline, after 20 weeks, and after 40 weeks.
Group II: Control (Non-Intervention) GroupActive Control1 Intervention
These patients will be asked to continue their current diet and lifestyle without making any changes for 20 weeks. They will be tested at baseline and after 20 weeks. Then, they will "cross over" and receive the same lifestyle medicine intervention for 20 weeks and will be tested again after 20 weeks of the intervention and also after 40 weeks of the intervention. After 20 weeks in the randomized control group, patients who no longer meet these eligibility criteria (e.g, a MoCA score \<18) will not cross over and will not receive the lifestyle intervention; their data during the first 20 weeks in the control group (when they met the entry criteria) will be used.
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Who is running the clinical trial?
Renown HealthOTHER
3 Previous Clinical Trials
5,755 Total Patients Enrolled
Harvard Medical School (HMS and HSDM)OTHER
203 Previous Clinical Trials
1,316,408 Total Patients Enrolled
University of California, San FranciscoOTHER
2,586 Previous Clinical Trials
14,900,013 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a very serious form of forgetfulness called severe dementia.You have a physical disability that prevents you from exercising regularly.You have a medical condition other than dementia or neurodegeneration that is causing similar symptoms, such as severe stroke or Parkinson's disease.You have serious mental health or drug abuse issues that are currently a concern.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental (Intervention) Group
- Group 2: Control (Non-Intervention) Group
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.
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