Can Lifestyle Changes Reverse Early-Stage Alzheimer's Disease
NCT ID: NCT04606420
Last Updated: 2022-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
51 participants
INTERVENTIONAL
2018-09-08
2023-09-30
Brief Summary
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Detailed Description
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After baseline testing, the first group then receives this lifestyle medicine program for 20 weeks, four hours/day, three days/week (all done virtually via Zoom since March 2020 due to COVID-19).
The second group will not receive the lifestyle program for 20 weeks and will serve as a randomized control group during this phase of the study.
Both groups will be re-tested after 20 weeks.
Then, the second group will "cross over" and receive this lifestyle medicine program for 20 weeks and the first group will continue the lifestyle program for 20 additional weeks. After a total of 40 weeks, both groups will be re-tested again and compared. Those initially randomly assigned to the control group will receive the intervention for 40 weeks and then be re-tested at that time.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
Due to challenges in recruiting patients, including Covid-19, we recently terminated recruitment after 51 patients were recruited. This decision was based on recruitment and funding issues, without review of any of the data. This trial will continue until all 51 patients have completed it.
TREATMENT
SINGLE
Study Groups
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Experimental (Intervention) Group
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.
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.
Control (Non-Intervention) Group
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Willingness and ability to participate in all aspects of the intervention
* Availability of spouse or caregiver who can provide collateral information and assist with study adherence
Exclusion Criteria
* physical disability that precludes regular exercise
* clear evidence for other causes of neurodegeneration or dementia, e.g., severe cerebrovascular disease, Parkinson's disease
* significant ongoing psychiatric or substance abuse problems
45 Years
90 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
Harvard Medical School (HMS and HSDM)
OTHER
University of California, San Diego
OTHER
The Cleveland Clinic
OTHER
Renown Health
OTHER
Preventive Medicine Research Institute
OTHER
Responsible Party
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Principal Investigators
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Dean Ornish, MD
Role: PRINCIPAL_INVESTIGATOR
President, Preventive Med Res Inst; Clinical Prof Medicine UCSF
Catherine Madison, MD
Role: STUDY_DIRECTOR
Chief Neurologist, Preventive Medicine Research Institute
Rudolph E Tanzi, PhD
Role: STUDY_DIRECTOR
Co-Director, McCance Center for Brain Health, Harvard Medical School/Mass General Hospital
Steven E. Arnold, MD
Role: STUDY_DIRECTOR
Director, Alzheimer's Clinical and Translational Research Unit, Harvard Medical School/Mass General Hospital
Jonathan Rosand, MD
Role: STUDY_DIRECTOR
Kistler Endowed Chair in Neurology, Harvard Medical School/Mass General Hospital
Douglas Galasko, MD
Role: STUDY_DIRECTOR
Professor of Neurology, University of California, San Diego
David A Sinclair, PhD
Role: STUDY_DIRECTOR
Co-Director, Paul Glenn Labs for the Biology of Aging, Harvard Medical School
Jonathan Artz, MD
Role: STUDY_DIRECTOR
Renown Health Institute of Neurosciences
Locations
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University of California, San Diego
San Diego, California, United States
Preventive Medicine Research Institute
Sausalito, California, United States
McCance Center for Brain Health, Harvard Medical School/Mass General Hospital
Boston, Massachusetts, United States
Renown Health Institute of Neurosciences
Reno, Nevada, United States
Countries
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References
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Other Identifiers
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20172897
Identifier Type: -
Identifier Source: org_study_id
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