Can Lifestyle Changes Reverse Early-Stage Alzheimer's Disease
NCT04606420 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51
Last updated 2022-09-15
Summary
The objective of this study is to determine if comprehensive lifestyle changes may slow, stop, or reverse the progression of early-stage Alzheimer's disease.
Conditions
- Alzheimer Disease
Interventions
- BEHAVIORAL
-
Lifestyle medicine
Diet: A low fat (10-15%) whole foods vegan diet, high in complex carbs and low in refined carbs (fruits, vegetables, whole grains, legumes, soy, seeds \& nuts). Calories unrestricted. Multivitamin, fish oil, curcumin, vitamin C, B12, CoQ10, lion's mane, probiotic, and magnesium. 21 meals/week and supplements provided to participants and caregivers at no cost to them. Exercise: Aerobic (e.g., walking) and strength training 30 minutes/day based on a personalized prescription from an exercise physiologist or certified personal trainer and registered nurse. Stress Management: Meditation, gentle yoga-based poses, progressive relaxation, breathing exercises, and meditation (with optional glasses) 1 hour per day, supervised by a certified stress management specialist. Group Support: Participants and their spouses/caregivers participate in a support group one hour/session, 3 days/week, supervised by a licensed mental health professional in a supportive, safe environment.
Sponsors & Collaborators
-
University of California, San Francisco
collaborator OTHER -
Harvard Medical School (HMS and HSDM)
collaborator OTHER -
University of California, San Diego
collaborator OTHER -
The Cleveland Clinic
collaborator OTHER -
Renown Health
collaborator OTHER -
Preventive Medicine Research Institute
lead OTHER
Principal Investigators
-
Dean Ornish, MD · President, Preventive Med Res Inst; Clinical Prof Medicine UCSF
-
Catherine Madison, MD · Chief Neurologist, Preventive Medicine Research Institute
-
Rudolph E Tanzi, PhD · Co-Director, McCance Center for Brain Health, Harvard Medical School/Mass General Hospital
-
Steven E. Arnold, MD · Director, Alzheimer's Clinical and Translational Research Unit, Harvard Medical School/Mass General Hospital
-
Jonathan Rosand, MD · Kistler Endowed Chair in Neurology, Harvard Medical School/Mass General Hospital
-
Douglas Galasko, MD · Professor of Neurology, University of California, San Diego
-
David A Sinclair, PhD · Co-Director, Paul Glenn Labs for the Biology of Aging, Harvard Medical School
-
Jonathan Artz, MD · Renown Health Institute of Neurosciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 45 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-09-08
- Primary Completion
- 2023-09-30
- Completion
- 2023-09-30
Countries
- United States
Study Locations
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