In the News
The Journal of Headache and Pain Reports that ElectroCore’s Non-Invasive Vagus Nerve Stimulation Treatment is Effective in the Acute Treatment of High Frequency and Chronic Migraine
Dr. Tieraona Low Dog, AIHM Fellowship Director, to Deliver First Interprofessional Integrative Fellowship
It's Time to Act on Obesity: Ethicon Expands Commitment To Help Reverse The Devastating Impact Of Metabolic Diseases
Stem Cell Therapy to Redefine Regenerative Medicine, says Frost & Sullivan
Faced with increasing challenges such as costly treatments and treatments that are palliative rather than symptomatic, the global healthcare industry today is gradually transforming itself. With few existing therapies capable of curing or significantly changing the course of a disease, healthcare providers are starting to look towards regenerative medicine as a viable alternative.
Regenerative medicine represents a new paradigm in human health with the potential to resolve unmet medical needs by addressing the underlying causes of diseases.
According to Dr. Jane Andrews, senior consultant, Healthcare & Life Sciences, Frost & Sullivan, regenerative medicine has the potential to cure diseases like we have never seen before. Because of this, the market, especially in the area of stem cell therapy, will continue to experience positive growth, boosted by support from other sectors.
"Regenerative medicine initiatives are now attracting new public and private funding. Although stem cell therapy will continue to be the largest market segment of regenerative medicine, cross segment therapies that combine the use of immunology, genetic, and stem cell therapy are rapidly advancing," Andrews noted.
Regenerative medicine has also been an area of interest for major pharma companies, many of which have set up their own R&D units or have acquired stakes/invested in regenerative medicine companies. Major pharmaceutical companies which have done so include Pfizer, Johnson & Johnson, and Teva Pharma.
Why Stem Cell Therapy?
In this space, cell therapy is the fastest growing segment of regenerative medicine and also the largest. Globally, the stem cell therapy market is expected to be worth US $40 billion by 2020 and US $180 billion by 2030.
Cell therapy involves the use of living cells to replace or augment damaged or diseased cells and tissues. It has been used for various conditions. The largest number of marketed cell therapy products is used for the treatment of notably non-healing wounds/skin (46 percent) and muscular-skeletal injuries (35 percent). This trend will change as more and stem cell therapy products for cancer and heart disease complete their clinical trials and are approved for market release.
Factors that are driving stem cell manufacturing in the short term include aging populations in need of alternative medicine and in the long term, new evidence that stem cell therapy works. However, an area of concern in the immediate future and long term remains the lack of early stage funding and the inherent variability in “living cells” culture and manufacturing.
"Despite this, it is expected that investors will increasing support for early and mid-stage clinical trials as this fast moving market continues to develop and show promise," explained Andrews.
Regenerative Medicine – The APAC Overview
The Asia-Pacific stem cell market was valued at US $7.10 billion in 2014 and is projected to increase to US $18.71 billion by 2018 at a CAGR of 27.3 percent for the period.
Sanjeev Kumar, consultant, Growth Partnership Services, Healthcare, Frost & Sullivan, Asia Pacific attributes the positive growth in APAC to strong support from the industry.
"This growth is a result of the increasing regulatory support regarding stem cell research, advancements in regenerative medicine and the opportunities arising from stem cell therapies," Kumar noted.
These opportunities include contract research outsourcing and rising patient population with neurological and other chronic conditions in the region. Japan, Singapore, and South Korea are the frontrunners and are set to dominate the APAC stem cell market in the coming years.
Japan is taking the global lead in promoting stem cell research for addressing conditions such as Parkinson's disease, spinal cord injuries, and cardiovascular disorders. In 2013, the Japanese government announced funding of US $1.12 billion for stem cell research on a stem cell type that is free from ethical concerns over embryo harvesting. Through this and other efforts, it hopes to eventually benefit from the cost savings generated by efficacious stem cell therapies.
With some success in commercializing stem cell therapy products for an open market matched by strong government support for R&D, South Korea's Regenerative Market is a prime area for growth, with key opportunities identified in the areas of Cell Therapy, especially in the stem cell therapy for adult stem cells and embryonic stem cells. These together with other drivers are on track to make South Korea one of the top three regenerative medicine markets by 2020.
Singapore is considered a haven for stem cell research, owing to its biomedical freedom in terms of favorable laws and strong government funding received, making it one of the most favored destinations in APAC for stem cell research. In addition, Singapore has a well-organized funding system in place for stem cell research which ensures that public and private funding are evenly divided among companies and researchers. The rapidly developing industry has also seen Singapore secure partnerships with FDA, UK Stem Cell Foundation, and corporate venture funds such as Novartis.
While North America remains the frontrunner in the regenerative medicine industry, the Asia-Pacific market is predicted to offer significant contributions to the market in the future.
Frost & Sullivan recently held its GIL Webinar—“The New Age of Regenerative Medicine: Why Stem Cell Therapy?”—in Singapore. To view the webinar, please visit brighttalk.com/webcast/5565/163681.
Please note this complimentary briefing requires a one-time registration on our web conferencing partner's website BrightTalk.
Source: Frost & Sullivan, frost.com
Discovery of Microbiome “Third Brain” Confirmed by Scientific Research in Japan
A scientific paper published In the July issue of the prestigious peer-reviewed scientific journal Anticancer Research describes the properties of a food product that is reminiscent of the “superfood for the third brain.” Japanese researchers from the universities of Tokushima and Kobe in Japan report the clinical results of treating patients with chronic fatigue syndrome and infections with a food based on
This finding supports the discoveries revealed in the book Your Third Brain, co-authored by Peter Greenlaw, Marco Ruggiero, MD, PhD, and Drew Greenlaw, with the forward written by author John Gray, PhD.
Four and a half years ago, a huge discovery was made. In 2010, a team of researchers discovered a new organ that had gone undetected for more than 3,000 years in human anatomy. They called this newly discovered organ the microbiome.
A June 23, 2015 New York Times story, written by Peter Andrey Smith, went into detail about the discovery of microbiomes and continued research on animals to discover the impact of microbiomes in the gut on mood and behavioral disorders.
The microbiome is much more than the gut microflora. It is a complex organ that is responsible for the development and function of all the other organs and systems, from the brain inside our heads to the immune system. The influence of the microbiome, that is located all over our body and not only inside the gut, on our behavior and intellectual functions is so significant that it can be aptly named “the third brain” as it is described in the book.
This is the life-changing work of Dr. Marco Ruggiero with his colleagues.
Dr. Ruggiero’s team is working hand in hand with the complete cooperation and unprecedented collaboration of medical doctors, with the goal of extending the highest possible quality of life for their patients for as long as possible. And although Dr. Ruggiero did not personally discover the microbiome, he did identify it as the third brain.
The team also discovered and published their observations that the fermentation process and the interaction of colostrum (the clear liquid created before breast milk) and mother’s breast milk with the bacteria, fungi, yeasts, and microbes begins the process to constitute the genetic information of the third brain (the microbiome).
To this end, they have published many papers about their work in prestigious peer-reviewed medical journals. It is important to point out that this successful formula is a combination of the most advanced medical procedures in combination with the interactions, approaches, and regimens that Dr. Ruggiero and his team have discovered in the scientifically demonstrated healing support of the third brain.
To support the health of the third brain, Dr. Ruggiero’s team created a superfood.
The research that is at the basis of the superfood for the third brain has been published by Dr. Ruggiero and colleagues since 2011; this independent confirmation coming from Japan further reinforces the scientific validity of their work.
The superfood for the third brain has been successfully used by thousands of people, including those with health challenges as well as healthy individuals.
The story of this discovery of the third brain and nutritional protocols to maximize the power of the first, second and third brains are detailed in the book Your Third Brain.
Dr. Ruggiero stated, “This book realizes the oldest of mankind’s dream: to overcome man’s limitations and reach the ultimate goal that is to exert complete control over our lives. Before this book was written, man did not know that his thoughts, feeling, emotions, behaviors, his supposed free will were under the control of a non-human organ whose existence had gone undetected until very recently, the microbiome.
“This book describes what is and how we can take control of this non-human third brain and aspire to bring out the superman that is inside us. As the Philosopher wrote: ‘Let your will say: the overman shall be the meaning of the earth... Man is a rope, tied between beast and overman—a rope over an abyss... what is great in man is that he is a bridge and not an end.’ Thanks to the information contained in this book, for the very first time in the history of mankind we can transform ourselves and reach this end.”
Source: Marco Ruggiero and Peter Greenlaw, petergreenlaw.com
Physical Exercise May Be an Effective Treatment for Alzheimer's Disease and Vascular Dementia
Positive results of three new randomized controlled trials of aerobic exercise in Alzheimer's disease, vascular cognitive impairment (VCI), and mild cognitive impairment (MCI) were reported today at the Alzheimer's Association International Conference 2015 (AAIC 2015) in Washington, DC. They provide hope there may soon be a tool that people with dementia can use to prolong their independence and improve their quality of life.
There is a convincing body of evidence that regular physical activity can reduce the risk of cognitive decline, and possibly reduce the risk of Alzheimer's disease and other dementias. In healthy older people, studies suggest physical exercise can improve cognition. However, until now, whether physical exercise could improve symptoms in people with Alzheimer's, or beneficially impact the physical changes in the brain caused by the disease, was unknown.
"Based on the results we heard reported today at AAIC 2015, exercise or regular physical activity might play a role in both protecting your brain from Alzheimer's disease and other dementias, and also living better with the disease if you have it," said Maria Carrillo, PhD, Alzheimer's Association Chief Science Officer.
"These findings also highlight the potential value of non-drug therapies for Alzheimer's disease and other dementias, and remind us that research ought to adamantly pursue combination and multi-modal approaches to Alzheimer's therapy and prevention," Carrillo said.
The evidence presented today at AAIC 2015 supports the guidance from the Alzheimer's Association that highlights regular physical activity as one of several proactive steps people can take to reduce their risk of cognitive decline. There is a growing body of evidence that certain lifestyle choices, such as staying mentally active, eating a heart-healthy diet, and staying socially engaged, can slow cognitive decline as people age. The Alzheimer's Association now offers 10 Ways to Love Your Brain: recommendations on how to reduce the risk of cognitive decline.
Physical Exercise Reduces Psychiatric Symptoms of Alzheimer's in Four-Month Study
At AAIC 2015, Steen Hasselbalch, MD, and colleagues from the Danish Dementia Research Centre (DDRC), Copenhagen, Denmark reported results from the Danish ADEX Study, the first large, controlled trial of moderate- to-high intensity exercise in people with mild-to-moderate Alzheimer's in Denmark.
In the ADEX study, 200 people with Alzheimer's age 50 to 90 (average age 70.9 years) were randomly assigned to either a supervised aerobic exercise program (60-minute exercise sessions three times a week for 16 weeks supervised by experienced physiotherapists) or a control group (standard care, no extra exercise). In the exercise group, after four weeks of adaptation exercise, participants performed aerobic exercise at a target intensity of 70 to 80 percent of maximum heart rate for the remaining 12 weeks.
The researchers studied the effects of exercise on a range of factors related to Alzheimer's disease. The primary outcome measure was change from baseline to 16 weeks in cognitive performance estimated by the Symbol-Digit Modalities test (SDMT). Secondary outcomes were neuropsychiatric and depressive symptoms, activities of daily living, quality of life, and other cognitive measures. No significant difference was found between the intervention and control group on the primary outcome, but there was a significant difference in neuropsychiatric symptoms in favor of the intervention group (p=0.002).
At AAIC 2015, the researchers reported that:
>>People who participated in the exercise program had far fewer neuropsychiatric symptoms (such as anxiety, irritability, and depression). Those in the control group had deteriorated on measures of psychiatric symptoms, while the intervention group improved slightly. This lead to a statistically significant difference between the two groups.
>>People in a subgroup of the exercise group who attended more than 80 percent of the classes and exercised vigorously (raising their heart rate to more than 70 percent of their maximal rate) had statistically significant (p=0.03) improvements on mental speed and attention, as measured by the SDMT.
>>In addition, people who participated in the exercise program improved in physical fitness, physical function, dual-task performance, and exercise self-efficacy.
"Symptoms such as anxiety, irritability, and depression that often occur in Alzheimer's disease are the cause of great distress in both caregivers and people with the disease," Hasselbalch said. "While our results need to be verified in larger and more diverse groups, the positive effects of exercise on these symptoms that we saw in our study may prove to be an effective complement or combination with anti-dementia drugs. This calls for further study of multimodal treatment strategies, including lifestyle and drug therapies."
The Danish ADEX study was a collaboration between the DDRC, eight memory clinics in Denmark, and the Musculoskeletal Rehabilitation Research Unit, Bispebjerg & Frederiksberg Hospitals, University of Copenhagen.
Aerobic Exercise Reduces Tau Protein in Older Adults with Mild Cognitive Impairment
One of the hallmarks of Alzheimer's is a brain lesion known as a tau tangle. Normally, tau functions to stabilize the structure of cells in the brain. When it becomes abnormal, tau initiates a variety of biological changes that can result in brain cells dying. Higher levels of tau in the brain are associated with faster rates of decline to Alzheimer's dementia. Therapies to prevent cognitive decline and dementia are now beginning to focus on reducing tau.
Researchers Laura Baker, PhD, and colleagues from Wake Forest Baptist Medical Center, Winston Salem NC, USA, had previously shown that in older adults with mild cognitive impairment (MCI), regular moderate-to-high intensity aerobic exercise has benefits for cognition and plasma levels of amyloid protein, the primary component of the other Alzheimer's hallmark lesion, known as plaques. At AAIC 2015, they reported results of a six-month randomized controlled trial of moderate-to-high intensity aerobic exercise in 65 sedentary adults 55 to 89 years old with MCI to test whether aerobic exercise might also lower tau levels in the brain.
Participants in the study were randomly assigned to either supervised aerobic training or a stretching group for 45 to 60 minutes four times per week for six months, using community facilities. The aerobic group exercised at 70 to 80 percent of their maximum heart rate, while the stretching group exercised at below 35 percent. The researchers tested participant's cognitive skills (verbal recall, tests of executive function) and examined blood and cerebrospinal fluid (CSF) samples at the beginning and end of the study. Forty participants also received MRI brain scans. Participants completed their assigned exercise activities 92 percent of the time.
The researchers found that:
>>Participants who completed aerobic exercise (most commonly using a treadmill) saw a statistically significant (p<0.05) reduction in tau levels in CSF. The effect was most pronounced in adults older than the age of 70.
>>Aerobic exercise significantly (p<0.05) increased blood flow in the memory and processing centers of participant's brains, with a corresponding improvement in attention, planning, and organizing abilities referred to as "executive function" (p<0.05).
"These findings are important because they strongly suggest a potent lifestyle intervention such as aerobic exercise can impact Alzheimer's-related changes in the brain," Baker said. "No currently approved medication can rival these effects."
Aerobic Exercise Improves Cognition in Vascular Cognitive Impairment in a Six-Month Trial
Cerebrovascular disease is the second most common cause of dementia in older adults, behind Alzheimer's. Research suggests that reducing heart health risk factors, such as high blood pressure and high cholesterol, may reduce dementia risk, and possibly even slow down the progression of cognitive decline due to mini-strokes—known as vascular cognitive impairment (VCI).
"This made us believe that aerobic exercise, such as running and brisk walking, may be a very promising strategy against vascular cognitive impairment," said Teresa Liu-Ambrose, Canada Research Chair, PhD, PT, University of British Columbia and researcher at the Djavad Mowafaghian Centre for Brain Health, which is part of the Vancouver Coastal Health Research Institute, Vancouver, BC, Canada. "Research shows that aerobic exercise not only decreases heart health risk factors but may also improve brain structure and function."
At AAIC 2015, Liu-Ambrose and colleagues reported results from a six-month study of 71 adults 56 to 96 years old with confirmed cases of mild VCI. Participants were assigned to two groups: One did supervised aerobic exercise three times per week for 60 minutes with certified fitness instructors, and the other group received usual care plus an education seminar on nutrition once per month. All received the ADAS-Cog, a standard test of memory and thinking, at the beginning and end of the study.
Of the 71 participants, 62 completed the full six-month study. The researchers found that study participants who took the aerobics classes significantly (p<0.05) improved their cognitive function, including memory and selective attention, compared with the people receiving usual care. In addition, functional brain scans acquired before and after the six-month study showed that the brains of study participants became more efficient with aerobic exercise training.
"While these promising results need to be replicated in larger and more diverse populations, the fact that aerobic exercise can improve cognitive function in VCI means that people with the condition have hope there may soon be a proven tool they can use to prolong their independence and improve their quality of life," said Liu-Ambrose. "Exercise is a strategy that can be inexpensively delivered at the population level."
Source: The Alzheimer's Association, alz.org
Researchers Report New Ways To Predict The Development Of Alzheimer's Disease
Brain scans, memory tests and body fluids such as saliva may hold the keys to understanding a person's likelihood of developing Alzheimer's, even among those who don't yet have memory and thinking problems associated with the disease, suggest four studies reported at the Alzheimer's Association International Conference 2015 (AAIC 2015) in Washington, DC.
Two of the studies suggest that an excess of certain proteins in cerebrospinal fluid (CSF) are strong predictors of Alzheimer's, and that the accuracy of these predictions is stronger when they are considered together with other diagnostic tools, such as memory tests or MRI brain scans. A third report suggests that new ways of creating images of inflammation in the brain with PET scans could one day be used to identify treatments that protect the brain. Finally, a small but intriguing study suggests it could be possible to detect Alzheimer's-like changes in saliva, which is easily obtained, safe and affordable, but there is a lot of work still to be done.
"There is now consensus that Alzheimer's disease begins with changes in the brain that are happening while people are still cognitively normal, decades before memory and thinking problems begin, which then accelerate as the disease progresses," said Dean Hartley, PhD, Alzheimer's Association Director of Science Initiatives. "Still, diagnosis of Alzheimer's usually happens fairly late in the progression of the disease, typically not until symptoms are severe enough to prompt a visit to the doctor."
"Earlier diagnosis or, better still, the ability to predict the onset of Alzheimer's, would significantly increase the window of opportunity a person with Alzheimer's has to formulate an informed response to the news and empower them to be an active participant in decision-making while they still have the ability. It also would help researchers choose participants for treatment research, especially people at the earliest, pre-symptomatic stages of the disease who are needed for prevention trials," Hartley said.
The Alzheimer's Association 2015 Alzheimer's Disease Facts and Figures report found that only 45 percent of people diagnosed with Alzheimer's or their caregivers say they were told the diagnosis by their doctor. Research suggests that one of the reasons doctors do not disclose a diagnosis of Alzheimer's is they have insufficient time and resources to provide support to patients and caregivers at the time of the diagnosis. Extending the time between diagnosis and the onset of symptoms could change that situation.
Six Factors May Identify People Most Likely to Get Alzheimer's Disease
Research suggests that certain biological changes take place over time that signal the future onset of Alzheimer's disease symptoms in people with otherwise normal memory and thinking skills. Understanding which changes are most predictive of Alzheimer's may help in the selection of candidates for clinical trials and help monitor an individual's response to treatment or prevention strategies.
Most Alzheimer's clinical trials have been conducted among individuals in the dementia phase of the disease. More recently, trials have been initiated during an earlier phase, known as mild cognitive impairment (MCI), where people have a significantly increased risk of progressing to Alzheimer's disease dementia. For more than a decade, these trials have been unsuccessful in identifying new Alzheimer's medications. A few clinical trials have recently been initiated among individuals in the preclinical phase of the disease. However, there is limited data on which to base the selection of individuals for a clinical trial in the preclinical phase; there is a great need for better tools for earlier detection and cognitive assessment to identify these individuals and track their progress.
To assess the usefulness of different predictive tests, Marilyn Albert, PhD, Director of the Division of Cognitive Neuroscience in the Department of Neurology at Johns Hopkins University School of Medicine and Director of the Johns Hopkins Alzheimer's Disease Research Center and colleagues repeatedly evaluated the mental status of 189 participants from the BIOCARD Study who were cognitively normal at the beginning of the study, They used a variety of measurement tools and identified those tools that best predicted the onset of MCI five years later. They found that the combined results of six measures were particularly useful:
- Two memory and thinking tests (the Digit Symbol and Paired Associates Immediate Recall tests).
- Levels of two different proteins in CSF (amyloid beta and p-tau).
- Two MRI brain scans – one to assess the thickness of the right entorhinal cortex and another to measure the volume of the hippocampus, both of which are important for memory.
Several statistical measures were used to characterize the accuracy of prediction, including the Area Under the Curve (AUC), sensitivity and specificity (AUC=0.886, sensitivity = 0.85, specificity = 0.70).
"Our study shows that – up to five years before any Alzheimer's symptoms appear – a small set of factors can tell us, with significant accuracy, which cognitively normal individuals will develop mild cognitive impairment due to Alzheimer's," said Albert. "We hope that this information will be useful for designing clinical trials aimed at delaying the onset of symptoms among cognitively normal individuals. An approach such as ours could be used for determining which people might be most likely to benefit."
Saliva Test May Identify Normal Aging, MCI, and Alzheimer's – Early Results
Early detection of Alzheimer's related symptoms is critically important for individuals with the disease and for clinical studies seeking to slow or stop disease progression. However, many diagnosis techniques can be costly or invasive. Saliva is simple to obtain, easily transportable, and has been successfully used in a variety of diseases and conditions. Since multiple samples can be readily obtained, saliva testing is particularly useful for performing repeated assessments that span days, weeks, months or longer.
Knowing that Alzheimer's typically co-exists with certain metabolic disorders, Shraddha Sapkota, MSc, a neuroscience graduate student at the University of Alberta, Canada, and colleagues reported success at AAIC 2015 in identifying substances in saliva that differentiated among people with Alzheimer's disease (n=22), MCI (n=25) or normal aging (NA; n=35). A validation sample included 10 NA, 10 MCI, and 7 participants with Alzheimer's.
The researchers conducted their study using saliva samples, clinical diagnoses and cognitive data from the Victoria Longitudinal Study (VLS), a long-term, large-scale investigation of human aging. Protein analysis technology, called liquid chromatography-mass spectrometry (LCMS), was used to analyze the saliva samples and identify which substances were predominant in the saliva of each of the three types of individuals. Linking that data back to each participant's clinical diagnosis, researchers reported strong associations between certain substances and a person's cognitive abilities. For example, higher levels of one substance in the MCI group and another in the Alzheimer's group were observed. When these were examined in NA, higher levels of both predicted worse episodic memory performance. Another substance with higher levels in the Alzheimer's group predicted slower speed in processing information.
"Saliva is easily obtained, safe and affordable, and has promising potential for predicting and tracking cognitive decline, but we're in the very early stages of this work and much more research is needed," said Sapkota. "Equally important is the possibility of using saliva to find targets for treatment to address the metabolic component of Alzheimer's, which is still not well understood. This study brings us closer to solving that mystery."
Neurogranin, a CSF Biomarker for Synaptic Loss, Predicts Decline to Alzheimer's Dementia
Cerebrospinal fluid (CSF) buffers and protects the brain and spinal cord; when the brain is injured or damaged, certain proteins are released into the CSF. Examining CSF has led to the discovery of proteins that are strongly linked to Alzheimer's and can be useful in assessing an individual's health status. One such protein is neurogranin.
Neurogranin is a protein found only in the brain and is involved in the communication pathways between brain cells, known as synaptic signaling pathways. Synapse damage and loss is a common, early feature of Alzheimer's and there is a strong correlation between the extent of synapse loss and the severity of dementia. Recent research shows that neurogranin levels in the CSF are elevated in people with Alzheimer's.
At AAIC 2015, Maartje Kester, MD, PhD of VU University Medical Center, Amsterdam, Netherlands and colleagues presented findings from a study of 162 individuals from the Amsterdam Dementia Cohort who were either cognitively normal, had MCI or Alzheimer's. All of the participants had two cerebral spinal fluid samples taken over the course of two years, allowing researchers to compare the protein content over time. Participants also had cognitive exams about four years apart, giving researchers a picture of how participants' memory and thinking status changed over time.
The research team found that baseline levels of neurogranin were significantly higher in individuals with Alzheimer's than in cognitively normal individuals. Initial neurogranin levels were also significantly higher in MCI individuals who progressed to Alzheimer's compared to those with stable MCI, and they were predictive of progression from MCI to Alzheimer's. They found that neurogranin levels were strongly correlated with two other Alzheimer's-related proteins, tau and ptau-181, in all three groups.
The researchers also observed that while neurogranin increased slightly over time in the cognitively normal group, it did not in those with MCI or Alzheimer's. "This may indicate that neurogranin levels in CSF reflect very early synaptic loss in Alzheimer's and may be useful for early detection," Kester said.
"We found that neurogranin is a potentially useful marker for the diagnosis, prognosis and monitoring of Alzheimer's," said Kester.
Imaging Inflammation in the Brain – Is It In Our Future?
PET imaging compounds for amyloid plaques in the brain have been FDA approved for use in people with suspected Alzheimer's disease but an unclear diagnosis or an unusual presentation, and, as reported at AAIC 2014, significant advances are being made in PET imaging of tau tangles. These are the two hallmark brain lesions of Alzheimer's disease and are thought to be involved in its cause and progression.
Inflammation is another condition/pathway being investigated for its role in Alzheimer's; it can be deadly to brain cells and may be activated by the plaques and tangles. Microglial cells, as the brain's immune cells, constitute the active immune defense in the central nervous system (CNS). They have the potential to either protect or – when activated – destroy critical links in the brain. Attempts have been made to develop treatments that keep the cells in a protective state.
Andreas H. Jacobs, MD, Professor at the European Institute for Molecular Imaging, Muenster, Germany, and Director of the Department of Geriatrics at the Johanniter Hospital, Bonn, Germany, presenting at AAIC 2015 on behalf of his collaborators from the INMIND consortium, gave an overview of the state-of-the-art in PET imaging of inflammation in the brain.
To monitor the effects of new treatments on microglial cells, researchers often use positron emission tomography (PET) scans to visualize active microglial cells by tracking a protein that is produced at higher levels when the cells are active/destructive. Use of this technique is limited, however, because the relationship between this protein and microglial function is not fully understood yet, making interpretation of imaging results challenging. Consequently, other imaging targets are now under investigation.
"The data reported at AAIC demonstrates the potential of new target structures – such as cannabinoid type 2, P2X7 and COX2 receptors – to more accurately reflect various stages or types of the microglial cells, telling us if they're being destructive or protective," said Jacobs. "It is our hope that these new imaging tools can help us assess the effectiveness of treatments that lessen their destructive behavior."
One World Cannabis to Offer New Alternative Treatment for Chronic Pain
OWC Pharmaceutical Research Corp., an Israeli-based developer of cannabinoid-based therapies targeting a variety of different indications, is offering new and alternative hope to patients diagnosed with chronic pain. The company's wholly owned subsidiary, One World Cannabis Ltd., has already filed two provisional patent applications with the USPTO related to the development of two unique formulations that include cannabis extracts and a new delivery system to treat fibromyalgia and migraines, and has begun researching and developing new cannabis-based therapies to help alleviate the suffering of patients experiencing enduring pain.
The news comes about after the FDA recently announced to increase existing heart attack and stroke warnings for both over-the-counter and prescription non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs), which are typically used to treat chronic pain. The cannabis-based novel treatment employed by One World Cannabis could be an alternative to NSAIDs to treat long-lasting pain and fever from many different long- and short-term medical conditions. In addition, the cannabis-based treatment will provide physicians, as well as patients, with the ability to control and administrate optimal dosage, thus offering an alternative to current delivery systems that are not acceptable to scientists and physicians, such as smoking marijuana, edibles, and oil extracts with no substantial dosage control.
"Chronic pain represents an emerging public health issue of massive proportions," said Dr. Yehuda Baruch, director of research and regulatory affairs." In light of the latest FDA calling on NSAIDs makers, One World Cannabis believes that our cannabis-based products and treatments will be an effective and safe alternative to acute and chronic treatment of pain."
Two months ago, One World Cannabis announced the signature of a collaboration agreement with Sheba Academic Medical Center, the largest hospital in Israel and in the Middle East. Within the framework of the agreement, One World Cannabis will initiate pre-clinical and clinical studies to explore the effect of several combinations of cannabidiol (CBD) and tetrahydrocannabinol (THC) on fibromyalgia, to offer patients a novel approach to the issue of chronic pain management.
The clinical study on fibromyalgia is expected to begin in the fourth quarter of 2015 after receiving IRB (Helsinki Committee) approval. The study will be headed by Professor Howard Amital, internist and rheumatologist, head of department of internal medicine and research center for autoimmune diseases at Sheba Academic Medical Center. Prof. Amital is an Associate Professor in Chair at the Tel Aviv University's Sackler Faculty of Medicine.
One World Cannabis also plans to start researching the relief of migraine attack symptoms, again by using a formulation comprising, inter alia, a therapeutically effective amount of THC and CBD. The clinical trial, as its protocol is written nowadays, will be conducted by the company in collaboration with another Israeli leading academic medical center.
Source: OWC Pharmaceutical Research Corp., owcpharma.com
The Journal of Headache and Pain Reports that ElectroCore’s Non-Invasive Vagus Nerve Stimulation Treatment is Effective in the Acute Treatment of High Frequency and Chronic Migraine
The study, which is in the July edition of the The Journal of Headache and Pain reports that electroCore’s nVNS treatment delivered by a gammaCore device was effective in reducing pain levels in more than 65 percent of the patients after two hours – the primary endpoint. Furthermore 65 percent achieved at least a 50 percent reduction in pain.
Migraine is a highly disabling condition with many of the treatments having both unpleasant side effects and a risk of generating medication overuse headache, which is a paradoxical increase in headache frequency and severity as a result of overuse of pain medication. GammaCore is seen as a new, easy to use treatment that patient self-administer with very few side effects. This study is one of a series, including double blind, sham controlled trials, demonstrating that nVNS is effective for many patients in both the treatment and prevention of cluster and migraine headaches.
This European multicentre study involved 48 patients (34 chronic and 14 high-frequency migraneurs) who experienced mild to moderate attacks. The patients self-treated a total of 131 attacks. Pain relief was reported for 51 percent of these attacks after two hours.
Professor Barbanti, an author of the study, commented “This trial continues to reinforce the results from previous studies which show that gammaCore appears effective for the acute treatment of migraine. Because it is well tolerated and is easy to use we hope that use of this therapy will help to decrease: patient’s reliance on medications that can cause side effects; safety concerns for some patients; and medication overuse complications.”
GammaCore is available through specialist headache and pain clinics across the EU and Australia. It is not yet available in the US.
Did the US Task Force Make the Wrong Call for Prostate Cancer?
Current US Preventive Services Task Force Guidelines for prostate screening may be impacting the detection of high-risk prostate cancer.
A new study from the University Health Network (Toronto) evaluated the impact of the guidelines against Prostate Specific Antigen screening on cancer detection rates and found that intermediate to high grade prostate cancers (defined as Gleason scores 7-10) detected per month had decreased from 17 to 10.
"This is not a subtle decrease and a big cause for concern," said Dr. David Samadi, chairman of urology and chief of robotic surgery at Lenox Hill Hospital. "That much of a decrease in aggressive prostate cancer detection could mean that younger men are out there right now with high-risk prostate cancers, and with these guidelines, will go undiagnosed. Men are deviated away from this important screening and miss the optimal cancer detection period for the most successful treatment and outcome. A simple PSA blood test can indicate current antigens in the prostate. It's quick and painless. I've seen it over and over again in my practice. This screening truly saves lives."
Researchers analyzed a total of 3,408 prostate biopsies and 1,601 prostate cancers were detected. The US Task Force Guidelines were based on evidence that low risk prostate cancer is over-diagnosed and over-treated. In this study, low risk prostate cancers detected per month did decrease from 8.5 to 5.5.
In spite of the guidelines, Dr. Samadi recommends all men get a baseline PSA at the age of 40 and to know their risk factors.
Instead of focusing on the benefits of PSA screening and how much it has actually helped the healthcare system, their recommendations focus on the complications of treatment, such as incontinence and erectile dysfunction.
However, these complications depend on how experienced the surgeon is that you are being treated by. Prostate cancer mortality was on the decline before the USPSTF issued its recommendation. Since incorporating the PSA test, there has been a 40 percent reduction in prostate cancer mortality in the United States.
"The PSA test is not a prostate cancer test, but it is a vital first step in identifying the potential presence of the disease. I am a firm believer in routine PSA screenings. In my experience, an elevated PSA is how many of my patients were diagnosed, combined with knowing their risk factors like family history. In the end, when we look back, that test saved their lives," stressed Dr. Samadi.
At Dr. Samadi's Prostate Cancer Center, the key approach is measuring the trend and velocity of the PSA over time. PSA mapping by a prostate cancer expert is the best way to determine if elevations are a cause for concern. A PSA level of 4.0 ng/mL is normal, while changes of more than 2.0 ng/mL over the course of a year could be an indicator of the presence of Prostate Cancer. But an elevated PSA must be weighed against specific prostate cancer risk factors such as age, family history, and lifestyle habits.
Did the US Task Force make the wrong call when it comes to screening for prostate cancer? The evidence is arising but you decide.
Men newly diagnosed with prostate cancer can contact world renowned robotic prostate surgeon, Dr. David Samadi, for a consultation via ProstateCancer911.com and by calling 212.365.5000.
Source: Dr. David Samadi
Cognizin Citicoline Supplementation Effective At Reducing Cocaine Dependence in Bipolar Patients
The results of a randomized, double-blind, placebo-controlled clinical trial showed that Cognizin citicoline (Jarrow Formulas) was effective at reducing cocaine use, based on urine drug screens, in patients with bipolar disorder and cocaine dependence. The study, published in the American Journal of Psychiatry in Advance, included a total of 130 outpatients with bipolar I disorder and cocaine dependence, who received either Cognizin citicoline or placebo add-on therapy for 12 weeks. Not only was citicoline well-tolerated for the duration of the study, but cocaine use was significantly reduced in the citicoline group. The positive treatment effects suggest that Cognizin citicoline could be used as part of an augmentation strategy for the treatment of cocaine dependence in bipolar patients.
Substance abuse has a well-documented, negative impact on bipolar disorder, but little research has been conducted on the treatment of patients with both bipolar disorder and substance dependence. Several studies report increased hospitalizations and other complications in patients with bipolar disorder who also have substance abuse disorders. The positive results of this study were similar to a previous pilot study of citicoline in patients with bipolar disorder and cocaine dependence, although notably, the studies used different designs.
"The study results show that Cognizin citicoline supplementation can offer additional support for patients undergoing treatment, particularly in the critical, early stages when Cognizin supplementation proved most effective," said E. Sherwood Brown, MD, PhD, professor of psychiatry at the University of Texas Southwestern Medical Center and lead researcher of the study. "In addition, citicoline has a favorable safety profile and no known drug-drug interactions, which make it even more useful as a treatment option for dual-diagnosis patients."
"Citicoline has several mechanisms of action, and based on results of previous studies, it's possible that citicoline can impact dopamine levels in the brain," said Danielle Citrolo, registered pharmacist and manager of technical services for Kyowa Hakko USA. "Previous research has shown that Cognizin citicoline supplementation works in the brain to support focus and attention, increase the synthesis of brain cell membranes, and restore brain energy by 13 percent in associated study groups, meaning it has far-reaching potential for those who are looking to make a positive impact on their own brain health."
In this study, both the placebo and citicoline groups submitted to three weekly urine drug screens. Mood was assessed by the Inventory of Depressive Symptomatology-Self Report, the Hamilton Depression Rating Scale, and the Young Mania Rating Scale.
This study's authors noted that Cognizin citicoline is the only treatment with positive findings in reducing cocaine use as assessed by urine drug screens in patients with bipolar disorder and cocaine dependence. Consistent with previous studies, the citicoline group in this study saw no significant group differences in manic or depressive symptoms following supplementation. At the same time, Cognizin citicoline decreased cocaine use without impacting mood, meaning the efficacy of citicoline for reducing cocaine use not only holds promise as a treatment in this population, but could potentially hold true for other patients.
Traumatic Brain Injury (TBI) Can Now Be Identified, Say Researchers in Largest Neuroimaging Study
After comparing more than 20,000 brain scans, researchers have identified differences between Traumatic Brain Injury (TBI) and Post-Traumatic Stress Disorder (PTSD) despite both conditions sharing common symptoms.
"This discovery is breakthrough information for anyone diagnosed with either TBI or PTSD or both," said Theodore Henderson, MD, PhD, a co-author of the study, published last week in PLOS One, the seventh most cited medical journal in the world. "Now that we can tell the difference between TBI and PTSD, clinicians can apply more targeted and appropriate treatments, and achieve advances with their patients."
Believed to be the largest functional neuroimaging study ("Functional Neuroimaging Distinguishes Post traumatic Stress Disorder from Traumatic Brain Injury in Focused and Large Community Datasets"), researchers used single photon emission computed tomography (SPECT) to obtain biological differences between TBI and PTSD in the brain. This neuroimaging method and landmark study "demystify" these two conditions that both may appear with symptoms like anxiety, depression, mood dysregulation, irritability, and other cognitive breakdowns, according to Dr. Henderson.
"This study contained a subset of closely matched patients and a larger dataset of "real world" patients with multiple psychiatric or neurological conditions. The accuracy of the closely matched study was 100 percent which replicates our research on Veterans with TBI or PTSD (wherein the accuracy was 94 percent). It clearly delineates the potential of SPECT as a biomarker in differentiating TBI from PTSD—a critical issue for anyone suffering from symptoms with no answers," said Dr. Henderson, a Denver-based psychiatrist specializing in treating complex conditions.
Dr. Henderson emphasized the importance of obtaining an accurate diagnoses for TBI or PTSD. "They may have similar symptoms, but treatments are very different," he said.
"For example, some treatments for PTSD can actually be useless and possibly even harmful for TBI," said Dr. Henderson. "Plus, TBI can refer to injury to any part of the brain, which would require different treatments as well."
Dr. Henderson said this news will be particular noteworthy for the millions of Americans who have played contact sports, citing sport-related concussion incidence rates being reported to top 3 million per year, according to the Center for Disease Control. "I hope to reach out to all the active and retired football players and athletes suffering from either of these conditions."
One of the latest treatments for TBI includes applying infrared laser directly to the skull of the injured area of the brain. Called transcranial near infrared light therapy (NILT), Dr. Henderson has seen clinical improvements among his patients, as this study reports.
SOURCE Dr. Theodore Henderson
Dr. Tieraona Low Dog, AIHM Fellowship Director, to Deliver First Interprofessional Integrative Fellowship
Upon being named Fellowship Director for the Academy of Integrative Health & Medicine (AIHM),Tieraona Low Dog, MD, created an interprofessional Fellowship to meet the growing demand from the integrative health community.
“Dr. Low Dog shares our vision. We have to transform the way we think about health, health care and collaboration. The AIHM Fellowship provides a unique space for acupuncturists, MDs, nurse practitioners, dietitians, naturopathic and chiropractic physicians, pharmacists, and others to work together toward a goal of patient-centered care.”
Said Dr. Low Dog, “Our goal is to change the paradigm of healthcare delivery from professionals working in silos, to a multi-disciplinary approach with the patient at the center. The Fellowship is innovative and will drive a new kind of collaboration among clinicians from diverse professions.”
Designed for full-time clinicians, participants in the two-year Fellowship will be able to maintain their practices while completing the program. The hybrid model will include distance learning, live retreats, and clinical components. An unprecedented second year elective model will allow participants to tailor their training to their own specialties.
The AIHM Fellowship draws from Dr. Low Dog’s decades of experience as an internationally renowned educator, physician, and thought leader in integrative medicine. At the University of Arizona, she led the curriculum development and trained over 600 integrative physicians, nurse practitioners, and physician’s assistants.
According to AIHM President, Mimi Guarneri, MD, “Dr. Low Dog shares our vision. We have to transform the way we think about health, health care and collaboration. The AIHM Fellowship provides a unique space for acupuncturists, MDs, nurse practitioners, dietitians, naturopathic and chiropractic physicians, pharmacists and others to work together toward a goal of patient-centered care.”
Dr. Low Dog believes that everybody should have access to the best of traditional and modern medicine. She sees the future of medicine as patient-centered, interprofessional, and team-based. Gaps in training between professions currently limits clinical practice, especially in regard to complex, chronic diseases. The AIHM Fellowship will address those gaps.
The AIHM Fellowship is currently accepting applications from medical, osteopathic, naturopathic and chiropractic physicians, dentists, advance practice registered nurses, physician’s assistants, licensed acupuncturists, registered dietitians, pharmacists, licensed clinical social workers, and psychologists. The AIHM Fellowship will meet criteria established by the American Board of Integrative Medicine (ABOIM), which offers a board certification for MD/DO physicians in integrative medicine.
AIHM Fellows will become interdisciplinary experts in Integrative Health and Medicine. Clinicians who can imagine being change-agents in this movement to transform the current health paradigm should connect online. For details, please contact Fellowship Program Coordinator, Kristen Gates at (218) 525-5651.
The Academy Fellowship will engage an academic partner to deliver the program according to the standards of the Accreditation Council for Graduate Medical Education (ACGME) and Accreditation Council for Continuing Medical Education (ACCME). The Fellowship academic partner will be announced within 45 days.