Alzheimer’s Disease

My colleagues and I are conducting the first randomized controlled trial to determine if the progression of early Alzheimer’s disease and mild cognitive impairment (MCI) may be stopped or reversed by a comprehensive lifestyle medicine program, based on pilot data as well as other relevant studies of less-intensive interventions.  

This program includes a whole foods plant-based diet low in fat and sugar with supplements; moderate exercise; stress management techniques; and support groups.  

This clinical research is being conducted via the non-profit Preventive Medicine Research Institute (a 501(c)(3) nonprofit public foundation) in collaboration with other institutions, including the University of California San Francisco (Dr. Elizabeth Blackburn), Harvard Medical School/Massachusetts General Hospital in Boston (Dr. Rudy Tanzi and Dr. Steven Arnold), the Karolinska Institute in Stockholm (Dr. Miia Kivipelto), Renown Health Institute of Neurosciences in Reno Nevada (Dr. Jonathan Artz), and the University of California San Diego (Dr. Douglas Galasko and Dr. Rob Knight).

The primary endpoint measure is cognitive function testing.  We are also studying changes in a variety of biomarkers that affect Alzheimer’s disease.  These include: telomere length at Dr. Blackburn’s lab at UCSF; changes in the microbiome at Dr. Knight’s lab at UCSD; inflammatory and other biomarkers at Dr. Tanzi and Dr. Arnold’s labs at Harvard; changes in metabolic biomarkers at Dr. Rima Kaddurah-Daouk’s lab at Duke.  These will provide important insights into mechanisms by which lifestyle changes may affect the progression of Alzheimer’s disease.

In this study, 51 patients who have early Alzheimer’s disease are being enrolled and are randomly-assigned to one of two groups.  Both groups will be tested at baseline using these state-of-the-art measures. 

After baseline testing, the first group then receives this lifestyle medicine program for 20 weeks.  The second group will not 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 change program for 20 additional weeks.  After a total of 40 weeks, both groups will be re-tested again and compared.

All meals are provided (21 meals/week) during the study to patients and also their spouses or caregivers along with training in stress management, exercise, and support groups three days/week, four hours/session.  There are no costs to participants for the food, training, or testing.  

This study has been approved by both the UCSF and Western Institutional Review Boards and is listed on clinicaltrials.gov.  

Since February 2020, due to Covid-19, this lifestyle intervention has been offered virtually via Zoom.  Patients make these lifestyle changes at home, and food is delivered to their homes.  

For the past 40 years, we have conducted scientific research, including randomized control trials and demonstration projects, proving for the first time that the progression of many other chronic diseases may be reversible by making these comprehensive lifestyle changes.  

These include reversing coronary heart disease, type 2 diabetes, early stage prostate cancer, high blood pressure, elevated cholesterol levels, and obesity.  Medicare created a new benefit category to cover this lifestyle medicine program for reversing heart disease nationwide, which has essentially the same intervention.  

A panel of nutrition experts convened by U.S. News & World Report has rated this way of eating as “The #1 Best Heart Healthy Diet” for 11 years since they began rating diets in 2011, including 2022.  What’s good for your heart is also good for your brain.  

The reason that these lifestyle changes are beneficial in reversing so many chronic diseases is that they affect many of the same underlying biological mechanisms.  For example, we found that changing lifestyle changes gene expression—over 500 genes in only three months—upregulating genes that facilitate health, downregulating genes that cause chronic inflammation, oxidative stress, and oncogenes that promote prostate cancer, breast cancer, and colon cancer.  

We also conducted the first controlled study showing that these lifestyle changes may lengthen telomeres, the ends of our chromosomes that regulate aging (in collaboration with Dr. Elizabeth Blackburn, who received the Nobel Prize for her pioneering work with telomeres).  Research indicates that there may be a causal relationship between shorter telomeres and Alzheimer’s.  

We are at a state of scientific evidence with respect to Alzheimer’s disease very similar to 44 years ago regarding coronary heart disease.  In other words, epidemiological data, anecdotal clinical evidence, and animal studies suggest that the progression of early-stage Alzheimer’s disease may be stopped or perhaps even reversed by making these comprehensive lifestyle changes, but no one has yet conducted this study.  

For example, other studies (e.g., the MIND study and the FINGER study) have shown that more moderate lifestyle changes may slow or help prevent progression to dementia.  We are studying if more intensive lifestyle changes may stop or reverse its progression.  

Whatever we show will be of great interest.  If this study is successful, it will redefine what is possible, thereby giving many people new hope and new choices.  If we show the intervention is not beneficial, then that will be important to know.  

Alzheimer’s disease currently affects over five million people at an annual cost of over $300 billion in the U.S.  By 2050, 16 million people are projected to be affected at an annual cost of $1.1 trillion.  As our population ages, this will increase.  There are currently no highly effective drugs for stopping or preventing Alzheimer’s.  And when you lose your memories, you lose everything.  

Thank you very much for your interest.  

Dean Ornish, M.D.
Founder & President, Preventive Medicine Research Institute [a 501 (c)(3) nonprofit foundation]
Clinical Professor of Medicine, University of California, San Francisco