The latest report from British Medical Journal reporters who investigated the FDA accelerated action program are showing that more than 2 in 5 drugs are not meeting the expectations for efficacy and quality. Maybe its time to consider alternative therapeutic models, especially for dementia and other neurodegenerative conditions that don't involve pharmaceuticals and can be self-administered at home by patients and their caregivers. Quietmind is working to engage in a comprehensive trial that will demonstrate the safety, reliability and efficacy of transcranial near infrared light therapy (tPBM) combined with brainwave biofeedback training. We've shown in expanded feasibility trials of tPBM conducted through Baylor Research Institute and Quietmind Foundation and our 15 years of clinical practice these tools are safe and rapidly effective in modifying cognitive and behavioral symptoms of dementia.
We hope to apply for accelerated action approval so that these therapies can be accepted and covered by Medicare and other insurances in the near future. Now, we are making the tPBM units available as wellness oriented interventions to support relaxation and improve overall cognitive and behavioral functioning.
Click here for article: www.medscape.com/
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.
Our team regularly publishes articles and blog posts on the latest research and news coming out of our group and the field in general.