Reversing Alzheimer's Trial in Bay Area

Plumster
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Reversing Alzheimer's Trial in Bay Area

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Dr. Dean Ornish and colleagues are conducting a randomized controlled study to see if diet and other lifestyle factors can actually reverse Alzheimer's. They are looking for willing patients in the Bay area. Here's his site.
My colleagues and I are conducting the first randomized controlled trial to determine if the progression of early Alzheimer’s disease may be reversed by a comprehensive lifestyle medicine program. This program includes a whole foods plant-based diet low in fat and sugar with supplements; moderate exercise; stress management techniques; and support groups.

We hope that this new study may be the first randomized controlled trial showing that any intervention may reverse the progression of early-stage Alzheimer’s disease, based on pilot data as well as other relevant studies of less-intensive interventions.

This clinical research is being conducted via the non-profit Preventive Medicine Research Institute (a 501(c)(3) public foundation) in collaboration with UCSF. The primary endpoint measure is cognitive function testing.

We are also studying changes in hippocampal volume at Dr. Howard Rosen’s lab at UCSF; telomere length at Dr. Elizabeth Blackburn’s lab at UCSF; changes in the microbiome at Dr. Rob Knight’s lab at UCSD; inflammatory biomarkers at UCSF; and measuring changes in gene expression and proteomics at Dr. David Sinclair’s lab at Harvard. We are also looking at changes in inflammatory markers. These will provide insight into mechanisms by which lifestyle changes may affect the progression of Alzheimer’s disease. Dr. Rudy Tanzi is a co-principal investigator (Joseph P. and Rose F. Kennedy Professor of Neurology at Harvard University, and Co-Director of the Henry and Allison McCance Center for Brain Health at Massachusetts General Hospital).

In this study, 100 patients who have early Alzheimer’s disease in the San Francisco Bay area 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, four hours/day, three days/week. 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. This study has been approved by both the UCSF and Western Institutional Review Boards.

All meals are provided (21 meals/week) during the study to patients and also their 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, testing, or transportation.

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 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.

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. This study was published with J. Craig Venter, who first decoded the human genome.

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). New 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 where we were 40 years ago regarding coronary heart disease. In other words, epidemiological data, anecdotal clinical evidence, and animal studies suggest that Alzheimer’s disease may be reversed by making these comprehensive lifestyle changes, but no one has yet conducted this study.

For example, other studies (e.g., the MIND and FINGER studies) have shown that more moderate lifestyle changes may slow the rate of dementia. We are studying if more intensive lifestyle changes may 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 valuable to know as well.

Alzheimer’s disease currently affects over five million people at an annual cost of $259 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 either treating or preventing Alzheimer’s. And when you lose your memories, you lose everything.

If you are interested in finding out more information about enrolling patients who live in the greater Bay area or in supporting this research, please call Colleen Kemp, RN, MSN at 415-332-2525 x-255 or 415-332-2525 x-229. Thank you very much for your consideration.

Dean Ornish, M.D.
Founder & President, Preventive Medicine Research Institute [a 501 (c)(3) nonprofit]
Clinical Professor of Medicine, School of Medicine, University of California, San Francisco
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circular
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Re: Reversing Alzheimer's Trial in Bay Area

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Plumster wrote:Dr. Dean Ornish and colleagues are conducting a randomized controlled study to see if diet and other lifestyle factors can actually reverse Alzheimer's. They are looking for willing patients in the Bay area. Here's his site.
My colleagues and I are conducting the first randomized controlled trial to determine if the progression of early Alzheimer’s disease may be reversed by a comprehensive lifestyle medicine program. This program includes a whole foods plant-based diet low in fat and sugar with supplements; moderate exercise; stress management techniques; and support groups.

We hope that this new study may be the first randomized controlled trial showing that any intervention may reverse the progression of early-stage Alzheimer’s disease, based on pilot data as well as other relevant studies of less-intensive interventions.

This clinical research is being conducted via the non-profit Preventive Medicine Research Institute (a 501(c)(3) public foundation) in collaboration with UCSF. The primary endpoint measure is cognitive function testing.

We are also studying changes in hippocampal volume at Dr. Howard Rosen’s lab at UCSF; telomere length at Dr. Elizabeth Blackburn’s lab at UCSF; changes in the microbiome at Dr. Rob Knight’s lab at UCSD; inflammatory biomarkers at UCSF; and measuring changes in gene expression and proteomics at Dr. David Sinclair’s lab at Harvard. We are also looking at changes in inflammatory markers. These will provide insight into mechanisms by which lifestyle changes may affect the progression of Alzheimer’s disease. Dr. Rudy Tanzi is a co-principal investigator (Joseph P. and Rose F. Kennedy Professor of Neurology at Harvard University, and Co-Director of the Henry and Allison McCance Center for Brain Health at Massachusetts General Hospital).

In this study, 100 patients who have early Alzheimer’s disease in the San Francisco Bay area 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, four hours/day, three days/week. 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. This study has been approved by both the UCSF and Western Institutional Review Boards.

All meals are provided (21 meals/week) during the study to patients and also their 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, testing, or transportation.

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 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. [Note if their program works Medicare might cover it to reverse cognitive decline too, although prevention would be better!]

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. This study was published with J. Craig Venter, who first decoded the human genome.

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). New 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 where we were 40 years ago regarding coronary heart disease. In other words, epidemiological data, anecdotal clinical evidence, and animal studies suggest that Alzheimer’s disease may be reversed by making these comprehensive lifestyle changes, but no one has yet conducted this study.

For example, other studies (e.g., the MIND and FINGER studies) have shown that more moderate lifestyle changes may slow the rate of dementia. We are studying if more intensive lifestyle changes may 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 valuable to know as well.

Alzheimer’s disease currently affects over five million people at an annual cost of $259 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 either treating or preventing Alzheimer’s. And when you lose your memories, you lose everything.

If you are interested in finding out more information about enrolling patients who live in the greater Bay area or in supporting this research, please call Colleen Kemp, RN, MSN at 415-332-2525 x-255 or 415-332-2525 x-229. Thank you very much for your consideration.

Dean Ornish, M.D.
Founder & President, Preventive Medicine Research Institute [a 501 (c)(3) nonprofit]
Clinical Professor of Medicine, School of Medicine, University of California, San Francisco
Thanks Plumster, this will be very interesting for a number of reasons. I've highlighted some portions that stood out to me. We need more and more trials of this sort so we can move away from people using epidemiology studies to reinforce their perspectives.
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Julie G
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Re: Reversing Alzheimer's Trial in Bay Area

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Really interesting, Plumster. Thank you for sharing. Dr. Ornish has trained under Dr. Bredesen. It looks like he’s generally using that same approach with a low fat, 100% plant based diet. This is one I’ll be watching!
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Re: Reversing Alzheimer's Trial in Bay Area

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I'm particularly interested to see what supplements are used and whether they will be customized based on participant lab values. Perhaps so if Dr. Ornish has trained under Bredesen.

Also, I can't find time to make side-by-side lists of the lifestyle modifications in this study, MIND and FINGER. The Ornish et. al. study to reverse cognitive decline say their modifications are more "intensive" than more "moderate" studies that have showed a slowing of decline (eg MIND and FINGER). I'd like to see that difference between "intensive" and "moderate" delineated if or when more details are available. Maybe it has to do with personalized screening to identify appropriate supplements for each participant? Or maybe it has to do with a more extreme plant based diet with less animal protein than allowed in MIND and FINGER?

This party of lifestyle studies is missing the high animal protein/omnivore flavors 8-)
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Re: Reversing Alzheimer's Trial in Bay Area

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I admire the fact that Dr. Ornish has built enough evidence of the efficacy of his lifestyle approach for heart disease that it's covered by Medicare. That's exactly the direction we need to be moving with lifestyle protocols for cognitive decline. This needs to become reimbursable standard of care. We get there with clinical trials like this. BTW, Dr. Bredesen's first will be concluding at the end of this year with very promising early results.
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Re: Reversing Alzheimer's Trial in Bay Area

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Julie G wrote:I admire the fact that Dr. Ornish has built enough evidence of the efficacy of his lifestyle approach for heart disease that it's covered by Medicare. That's exactly the direction we need to be moving with lifestyle protocols for cognitive decline. This needs to become reimbursable standard of care. We get there with clinical trials like this. BTW, Dr. Bredesen's first will be concluding at the end of this year with very promising early results.
Thanks for the background link. I hadn't known that Dr. Ornish's approach was covered by Medicare until I saw the reference in the OP.

Another page at Dr. Ornish's website says:
The reason Ornish Lifestyle Medicine promotes a plant-based diet that does not include meat, poultry, seafood or fish is because 35 years of research, including peer-reviewed, controlled double-blind studies, have shown that a low-fat, no-animal protein (with exception of limited and optional egg whites and nonfat dairy) not only reverses heart disease but also has positive impacts on Type 2 diabetes, hypercholesterolemia and high blood pressure. It even slows, stops or reverses the progression of early-stage prostate cancer.
The exclusion of meat, poultry, seafood or fish won't be news to those familiar with Dr. Ornish's work, but I thought it worth highlighting. One thing that interests me here: to distinguish whether the evidence showing Dr. Ornish's approach can reverse heart and other diseases can be repeated, but including a diet higher in animal and fish/seafood protein coming from pastured/regenerative and other environmentally sustainable sources. Would both approaches show the same results? Is it meat, fish and seafood making people sick and preventing their recovery (in the diet component of the lifestyle) or the food system that's trashing our body and environmental ecosystems?

In healthy asymptomatic groups, which orientation leads to higher levels of functioning in old age without going through the disease state to begin with?

Since Dr. Ornish knows Dr. Bredesen's protocol, it would be ideal if they would run all the trial participants through ReCODE to see whether Dr. Ornish's results can be stratified by Dr. Bredesen's three 'types'. For example do those with the inflammatory type have a harder time benefiting from Dr. Ornish's program without inflammatory side effects from the lectins and diminished anabolic and micro-nutrients that more animal protein and/or fish/seafood could provide?

So these lifestyle studies are good and needed but still lead to a lot of questions which will take decades to sort out. Hopefully Dr. Ornish's new study will be another successful step on the way to addressing all these issues, while I hope that people don't extrapolate findings to other questions. If it can be shown that the quality of meat and seafood is the problem, not the food items themselves, we can go after the food system that I think may be the primary driver of disease. It will also leave us with more tools to use in a shift to an environmentally sustainable foods system where production and food options can be customized to local conditions.

Just musings, not a criticism of what Dr. Ornish is pursuing. It seems it should show some good results given the intimate dance between cardiovascular and brain health :D
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Re: Reversing Alzheimer's Trial in Bay Area

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Just musings, not a criticism of what Dr. Ornish is pursuing. It seems it should show some good results given the intimate dance between cardiovascular and brain health :D
I appreciate your musings. :D FWIW, I suspect that Dr. Ornish has shown the success that he has in spite of the zero animal protein as opposed to because of it- just my opinion, of course. His program (like Dr. Bredesen's) is multifactorial, so isolating that specific strategy would be important. In terms of cognitive health, we KNOW the brain needs omega-3 fatty acids and choline, both difficult to get from plants alone. My guess is that he will have to do some supplementing to meet these specific needs and others, including B12, Vitamin D, retinol, zinc. etc.
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Re: Reversing Alzheimer's Trial in Bay Area

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The Ornish diet is a tough one. When my hubs did a heart scan many years ago and the results weren't good, we followed the Ornish plan for some time. Hubs did fine, but with the emphasis on grains, beans, legumes, soy foods, and small amounts of nuts & seeds for protein, my gut and joints suffered mightily. I was diagnosed with RA around that time, and I tried to reduce the grains, legumes, beans and soy foods on the advice of my integrative doctor at the time, but it's just incredibly hard to get the protein one needs without them. I don't have the full suite of celiac genes, but I do have some, so one thing I would urge anyone considering this diet, is to understand if gluten and/or specific lectins (Sarah Ballantyne has a very complete look at lectins in her first book) are a problem for them. I'm still trying to heal my gut over 10 years later.

I'm truly glad the Ornish approach works for some, but for me, soy and whole grains (especially gluten) are inflammatory, which we all know are not good for brain or overall health. One size doesn't necessarily fit all even if the aggregate data are positive.
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Re: Reversing Alzheimer's Trial in Bay Area

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The objective of the Ornish diet is to reduce inflammation by avoiding inflammatory foods (primarily saturated fats). With your food sensitivities, Susan, his diet is clearly far from ideal. I don't have a problem with soy or lectins, but gluten makes my joints hurt in addition to giving me stomach pain, so I avoid it. But there are plenty of glutenfree whole grains to choose from, still, and they work for me: brown rice, quinoa, job's tears (served like al dente pasta), teff (think Ethiopian injera), millet, buckwheat, and even airpopped popcorn. I have hot buckwheat cereal (Bob's Red Mill) with flax, Ceylon cinnamon and lots of berries every morning and love it. Turning fully plant based is one of the best things I have done for myself, especially now that I know my genes (my reports from Rhonda Patrick and Promethease turn saturated fats into the devil :twisted: ).

Here's a recent Zoom meeting (June 23, 2020) between Dean Ornish and Glenda Greenwald from the Aspen Brain Institute and Neal Barnard: "Can Diet and Lifestyle Changes Prevent and Reverse Alzheimer’s?" I haven't listened to it yet, but it's here on Facebook.
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Re: Reversing Alzheimer's Trial in Bay Area

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I pretty much can't eat any of the whole grain alternatives. I tried that route when giving up gluten, and just couldn't tolerate them. Glad it works for you. Finding the right diet is definitely important for each of us!
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