The latest review of Aducanumab (Aduhelm), the recently FDA approved medication for Alzheimer's, has been determined to have 'Zero Benefit' as determined by the California Technology Assessment Forum in a recent report to the Institute for Clinical and Economic Review (ICER). The stunningly depressing and ironic fact is that the report decries the lack of effective medications for Alzheimer's while not considering supporting treatment alternatives, e.g., transcranial infrared photobiomodulation, that have published clinical efficacy in reversing both cognitive and behavioral symptoms in subjects diagnosed with mild to moderate dementia.
Hopefully more people will recognize that there are options available to influence the slope of decline as well as taking steps to prevent disease onset using what are considered 'alternative' approaches like those advocated by Dale Bredesen and Apollo Health (https://www.apollohealthco.com/). Quietmind Foundation is proud to have been invited to partner with Apollo Health in advocating for the development of noninvasive, non-drug treatment protocols for Alzheimer's and other neurodegenerative disorders.
Link to the Medscape article: zero benefit to dementia patients while costing $56,000/yr.
The new drug from Biogen carries a very hefty price tag along with a very limited level of efficacy that has now been further limited by recent FDA labeling guidelines. The drug that costs $56,000 a year and is delivered intravenously is designed to flatten the slope of cognitive decline and will not reverse memory loss, behavioral challenges or other functional deficits.
The irony is not lost on us that transcranial infrared photobiomodulation, a treatment for which there is published evidence of reversal of memory, mood and motor symptoms and costing less than $4000, has not been afforded much recognition within the mainstream Alzheimer's treatment community. We are hopeful this will changes as clinicians like Dr. Dale Bredesen recognize and advocate for the use of this technology in the treatment of neurodegenerative disorders.
Quietmind Foundation has been selected to partner with Dr. Bredesen's company Apollo Health to provide consultation and training in the clinical use of photobiomodulation with their practitioners and patients. We are excited by this important opportunity and look forward to working with this community of providers and consumers and hope the word will spread and more people will be able to take advantage of this important neurophysiological health resource.
Alzheimer’s was first identified in 1906. Over a hundred years later, there's still no curative treatment for the disease. What we do have are potential procedures, lifestyle changes, and medications that help slow down its progression. Just recently, the Food and Drug Administration (FDA) approved a new Alzheimer’s drug, Aduhelm. And it’s been met with a lot of mixed reactions from the scientific community. To get FDA approval, drugs must go through two Phase III trials with positive results. Aduhelm skipped both and only presented preliminary results. It’s one of the first few drugs specifically made for Alzheimer’s; bypassing the processes may set a negative precedent for further research and trials. It creates more doubt and disagreements within the scientific community and mistrust among the general public.
There’s no space for dubious processes in Alzheimer’s treatment research, not when there are a number of other roadblocks to overcome.
Lack of Funding
A study conducted by the Rush Alzheimer’s Disease Center found that Alzheimer’s-related deaths are now nearly on par with cancer deaths, claiming 500,000 lives annually. Despite that, research funding for Alzheimer’s ($550 million) doesn’t even come close to half of the funds dedicated to cancer research ($5.7 billion). In fact, many research teams have had to turn to private funding and seek out donations to continue their studies on non-drug Alzheimer’s treatment. This isn’t to minimize the severity of cancer – it still is a serious and debilitating disease – but considering how Alzheimer’s is just as pervasive, it should also be prioritized.
From a macro perspective, the U.S. ranks low in elderly care among other rich countries. Perhaps since Alzheimer’s is perceived more as a condition of the elderly, it’s not given much importance. The study highlighted how dire the need is for government and systemic support. In response to the worrying figures, Alzheimer’s advocates have called for a sense of urgency from the government. They pointed out that without swift action and effective treatment, Alzheimer’s-related deaths will continue to rise. It’s a condition that’s just as life threatening as cancer and there should be more support in finding cures.
A compounding effect of the lack of funding is the lack of knowledge about Alzheimer’s disease. While there’s a general understanding that Alzheimer’s is linked to the plaque formation of beta-amyloid in the brain, researchers are still debating whether it’s a cause or a symptom of the disease – this is a concern since these plaques are used as biomarkers of Alzheimer's.
What’s more, there’s a disproportionate standard of imaging and non-imaging biomarkers. Doctors generally rely on lab tests, scans, and exams to evaluate the symptoms of the disease. But there’s a need to advance non-imaging biomarkers since the condition is difficult to confirm based on imaging diagnostics alone. There are behavioral and cognitive biomarkers that need to be studied and determined. It's only when these theories are substantiated that effective treatment can be made.
Studies on Alzheimer’s have been dominantly focused within the neuroscientific field. This means that only a select few are regarded as authorities on the subject. However, that’s been challenged in the modern interdisciplinary research environment. Professionals from different disciplines need to have access and opportunity to spur on Alzheimer’s research.
Today, many healthcare and research professionals are pursuing continuing education and exploring specialties in cognitive sciences, particularly through online institutions that allow them to study and maintain their careers. This is evident in online MSN degrees, in particular, which lead nurses to more advanced practice specializations. These degree-holders are taught to take a holistic approach, providing both medical care and assistance in making lifestyle choices as well. This makes them valuable assets to Alzheimer’s research, especially as we begin to see the condition beyond just the medical lens. Moreover, research for Alzheimer’s treatment should run the gamut from a range of biomedical science perspectives – or even those with training in engineering and computational science – to speed the process along. Expertise in neuroscience alone can only take treatment discovery so far.
Treatment Options Focused on Pharmacology
Despite the growing body of published clinical evidence that the symptoms of Alzheimer’s and other dementias can be treated and in some cases prevented – by lifestyle change, photobiomodulation, neurofeedback training and functional medicine, many healthcare professionals still insist on single molecule pharmacology. This is due, in part, to the skewed credence given to traditional allopathic neurologists who staunchly advocate for medications and invasive therapies. Much like all new views in medicine, new ideas are often initially met with resistance and overcoming resistance takes time to educate physicians and relentless patient advocacy that allow people to make new choices for their loved ones and themselves.
As it is, medical institutions can barely service the demand. Home-based, self-administered, systemically-oriented treatment solutions that are safe, affordable and grounded in rigorous scientific evidence are what is needed. One such solution is the RECODE protocol advanced by Dr. Dale Bredesen. It’s essentially a lifestyle modification method that aims to delay or protect against neurodegeneration. The protocol suggests targeting and improving 36 lifestyle factors that have been shown to contribute to cognitive decline. The protocol advocates for removal of systemic toxins include heavy metals, mold and other environmental pathogens, regular aerobic exercise, and intermittent fasting and a Mediterranean diet. Dr. Bredesen and his colleagues at Apollo Health strongly support the idea that dementia is the result of long term systemic inflammation and that changes of the kind he suggests can enhance cognitive function and reverse decline at any age. Recent dialogue between Quietmind Foundation President Marvin Berman and Dr. Bredesen (Bredesen Facebook Live have shown how closely their ideas and practices are aligned and future combined trials have been mentioned.
Given the support and chance to grow, many non-invasive and non-pharmacological methods could be discovered to treat Alzheimer’s. These could be game-changing for both patients and the healthcare system. These types of treatments would allow Alzheimer’s patients to require less inpatient care, letting them continue treatment at home.
Even if there are a number of roadblocks, there’s still much hope for a safe, effective and affordable Alzheimer’s treatment. Recognizing these challenges is the first step in overcoming these hurdles.
This article was prepared especially for www.quietmindfdn.org by Alice Palmer
Combining Photobiomodulation and Neurofeedback and Functional Medicine with Dale Bredesen, MD and Julie Gregory
I was extremely pleased to be interviewed by Dr. Dale Bredesen and Julie Gregory on Dr. Bredesen's Facebook Live channel on Thursday.
We covered a range of topics related to the mechanisms of action of infrared light photobiomodulation (PBM) and other forms of non-invasive stimulation, neurofeedback training and how these safe, reliable, affordable technologies can enhance the effectiveness of functional medicine as a treatment model for neurodegenerative conditions. This will hopefully be viewed those patients and clinicians who have trained and are affiliated with Apollo Health in order to expand the availability of these types of home-based, low-cost, non-drug, noninvasive treatment options for people seeking to stop or prevent cognitive and functional decline.
We will post the full transcript of the program along with additional links to information discussed in the program and some discount codes for purchasing the light therapy devices. I'm quite keen to see how we can put together a trial that will combine RECODE, PBM and neurofeedback.
Researchers are now able to report that the COVID 19 virus has the ability to cause small vessel damage to the brain tissue itself and not impair neuronal activity as was previously thought. The key point was made by the study author, Anna Cervantes, MD "Even though most of the coagulopathy is largely venous and probably microvascular, this does affect the brain through a myriad of ways". Our efforts to encourage the use of photobiomodulation are rooted in the knowledge that inflammatory processes include microvasular occlusion resulting in hypoperfusion. These are the fundamental hallmarks for all neurodegenerative disorders and why we advocate so strongly for taking prophylactic steps now to protect our brain with near infrared stimulation and functional medicine to reduce or hopefully remove neurotoxicity.
The combined approach of photobiomodulation and neurofeedback has proven to be of considerable benefit to many patients who needed to feel a sense of hope and control over their condition which is a key part of the integrative health model at QMF.
The list of symptoms that are now being seen to have links to COVID 19 infection are growing especially in the area of neurological and neuropsychiatric conditions. I think we are going to be seeing a large increase in people reporting these kinds of problems over the coming months and years and neurologists and mental health professionals are going to need all the tools they can muster to help their patients recover.
One very recently reported area of dysfunction is the brainstem which controls many basic life functions, include respiration, cardiovascular, gastrointestinal functions and neurological functions. We must be vigilant about making sure that the brain is protected against further injury from the COVID virus which can attack areas around the brain while not necessarily attacking the brain itself. Photobiomodulation is a way to treat the brain tissue that can provide protection against future injury while boosting the resources that are needed to help heal and improve overall brain functions.
Read the article here: https://pubmed.ncbi.nlm.nih.gov/33538586/
The point of the paper is to focus on the value of a particular RNA component that appears to regulate neuronal growth in the stem cell. The more mature cells in the brain, the better protection against degeneration was seen. Our research partners at Durham Univ. are keen to study the effects of photobiomodulation on Micro-RNA behavior and we are actively fund raising for to support these studies. Please consider helping us with this effort with a tax deductible donation to the QMF research fund.
The current efforts we've undertaken show that photobiomodulation has positive effects on mitochondria and other cellular components associated with neuronal health and resistance to damage. Our hope is that we can further clarify the specific mechanisms down to the most basic level in order to optimize the treatment models we can then develop for a wide range of neurodegenerative and neuropsychiatric conditions.
We can see this is an important aspect of how we may be able to intervene in the post-COVID long hauler syndromes that are emerging now, especially in neurology and psychiatry. It may be that targeted dosing of this treatment can bring about substantial improvement in patients now struggling just to survive the day.
I'm now at a new level in my efforts to influence public opinion regarding the use of noninvasive treatments for cognitive and behavioral symptoms associated with dementia. We've now had a report on a multi-site, randomized, placebo-controlled clinical trial conducted within the Dept. of Neurosurgery at Baylor Scott & White Medical Center which is affiliated with Texas A&M School of Medicine published in a peer-reviewed journal
Stimulation as a concept evokes all manner of associations from sexual to intellectual and all stops in between up and down the spinal column. The need for an anxieties associated with stimulation fill many books and other forms of artistic and cultural expression. There is a growing appreciation for the application of light stimulation as a healing methodology especially in the context of neurological disorders including dementia or memory loss, movement disorders like Parkinson's and ALS and the myriad of challenges that arise from exposure to the modern sources of toxicity, eg. pollutants and electromagnetic fields and those we have lived with for millenia and are only now beginning to recognize like Lyme disease and other tick-borne infections.
This article is a good source for basic information on photobiomodulation and more about the Vielight product line. We've been pleased with what we have been able to achieve using the Vielight with some patients and disappointed where the need for broader stimulation at different pulse rates and depth was needed. We can now provide alternative treatment options when the Vielight is not the appropriate tool for the job in our opinion. Our expertise and experience can be very helpful to folks who are looking for specific results and have a unique set of clinical conditions and history that really needs to be considered closely in order to provide the optimal protocol for using photobiomodulation. This kind of information is not what you get from a blog post or a device review and certainly not from the manufacturer's website as this would be a violation of the boundaries around making claims beyond what you are cleared to make by the regulatory bodies that manage medical device registration etc.
Seek professional clinical consultation for specific application of these technologies to safely and reliably get what you are seeking from these highly effective and promising tools.
Really tough question for sure. I am regularly in the position of being asked whether the things we can offer will help someone's parent, spouse, sibling, lover, partner recover their memory and other cognitive and physical functioning. I understand that I'm going to be asked these questions and each time my internal experience is that I have to answer this for the first time. Each situation is different and yet there are some aspects that are unchanging, mainly the profound pain and fear coming from the questioner. I take in their feelings and it resonates with my own sense of urgency, frustration and fundamental impotence.
What we know is that in principle the combining of functional medicine, neurofeedback and light therapy can have a profound effect on the progression of dementing illnesses. The root cause analysis is crucial to being able to address each person's condition effectively. This is not difficult to understand and yet it is a challenge to explain this to people struggling with loss of cognition and their family members who are seeking answers and solutions. Explaining the 3-legged stool that comprises our thinking is sometimes hard to grasp and yet is necessary to elicit compliance especially when we are not talking about a shot or a pill taken once or twice a day. Especially when we are talking about spending sometimes thousands of dollars on therapies that are not acknowledged to be effective by the FDA or Medicare or the AMA. We are asking people to trust us with their lives and resources at an extremely vulnerable point in their lives and this must be dealt with directly and with complete transparency and integrity.
We have evidence that what we're suggesting works, studies have been published but they are few and the sample sizes are often less than 50 subjects. Our recently completed trial on transcranial and intraocular infrared photobiomodulation had 100 subjects in two sites which makes it larger than the typical study in this field. Our collaborators being a large academic medical institution is also a helpful addition to bolstering our credibility. The point is that there is evidence to support the use of these methods of treatment and they are not what is being promoted on television or currently being funded by the NIH. We are hopeful that this will change soon and that combined photobiomodulation and neurofeedback training will find support within the Alzheimer's Clinical Trials Division.
The hard part of knowing when to stop compulsively trying the next thing that 'might help' is how to cope with the thought that you didn't do everything you could. We don't want to be blamed by others but moreso not by ourselves for having stopped trying to 'help'. How to live with the guilt and recrimination? Admit that you were doing things more to reduce your distress than to help them recover. If we listen to the traditional doctors these days, there's 'nothing to be done' other than palliative and hospice care for people with moderate to severe dementia. I think this has led folks to terrible conflict wherein they want to accept the relief of 'there's nothing I can do' while feeling the need to 'do something'. The hard conversations that must be had with family to admit what they are feeling and then be guided as to what can be done to support their loved one while also supporting the family as a whole's survival and well being. The questions about 'how long do we want this to go on? What is realistic for us to do to help them recover, i.e., how much time, energy and resources can we put toward this endeavor? How do we support each other in managing our guilt when it comes up and how to do we manage our impulses to reduce our own difficult feelings by putting them on someone else?
Don't skip over these conversations not matter how much you'd like to as they will serve the family and you in the years ahead.
Our team regularly publishes articles and blog posts on the latest research and news coming out of our group and the field in general.