Apex committee on clinical trials gives nod to 41 fresh proposals

The apex committee on clinical trials, constituted by the Union health ministry on the directive of the Supreme Court to monitor the clinical trial sector in the country, has cleared a total of 41 new proposals, 26 proposals of global clinical trials and 15 in other areas. These trials were approved by new drug advisory committees (NDACs) and thereafter the technical committee, another high-level panel formed by the ministry on this purpose. 

According to senior officials in the ministry, the apex committee in its 14th meeting held on June 17 deliberated in detail on the new proposals and ratified the recommendations made by the technical committee.   Earlier, the technical committee in its two meetings had evaluated and recommended for 41 proposals of various categories of clinical trials.  

As per the direction of the Supreme Court made in its order April 21, 2014, the proposals of global clinical trials/ clinical trials of NCEs are required to be evaluated with regard to three parameters like the assessment of risk versus benefit to the patients; innovation vis-à-vis existing therapeutic option; and unmet medical need in the country. 

Out of the total 41 cases, 26 cases were global clinical trials/ clinical trials of NCEs and the rest 15 cases were related to clinical trials for approval of new drugs including fixed dose combinations, subsequent new drugs and biologicals.

Headed by union health secretary Lov Verma, other members of the apex committee are DHR secretary Dr VM Katoch, DGHS Dr Jagdish Prasad and Arun Panda, joint secretary, health ministry. DCGI Dr GN Singh and the RK Jain, additional secretary, health ministry are the special invitees of the apex committee. 

Pfizer (Pregabalin, Lyrica),  Bristol-Myer Squibb (Dapagliflocinpro panediol),  PSI CRO Pharma India (Eravacycline, TP 434), GSK Pharma (Herpes zoster gE recombinant protein adjuvanted with AS01B adjuvant system), Spectrum Clinical Research (Apitox purified honeybee (Apismellifera) venom), Sanofi Pasteur India (Meningococcal (groups A, C, Y and W-135) polysachharide diphtheria Toxoid conjugate vaccine Menactra),  Pfizer (PF-05280014, trastuzumab), Novartis Healthcare (INC424, Ruxolitinib),  Cliantha Research (Bevacizumab biosimilar, BEVZ-92) are some of the companies who applied for global clinical trials and got the approval.

Source:Pharmabiz

The Best & Worst Sleeping Positions & How They Affect Your Health

It has been said that we spend about 1/3 of our lives sleeping. Since we know sleeping is quite important for our health, physical body, mental function and overall mood, it’s important we get good sleep. Having trouble with sleep can be caused by a number of things ranging from a bad mattress, a room with too much light, eating or drinking the wrong things before bed or even something like your sleeping position.

The Right Position For You

Depending on the sleeping position you choose, it can cause shoulder pain or back pain, increase wrinkles on the face and breasts, or even increase snoring. On the flip side, other positions can be great for increasing blood flow, minimizing acid reflux and decreasing snoring. All in all, your position can also be the difference between a good sleep and a bad sleep. Remember to experiment with the positions for a little longer than one night. Sometimes we get used to sleeping one way for so long that it takes a bit of adjusting to make a new one work.

The Positions

If you want to get great sleep and want to know if your sleeping positions are optimal for you, check out the images below to find out how your current positions might be affecting your health and whether or not it might be worthwhile to try some new ones. First you will find an image put together by the Huffington Post and then you will find 8 images of positions along with how they affect your health.

 
Sources:

http://www.webmd.com/sleep-disorders/features/sleep-position-and-sleep-quality

http://www.huffingtonpost.com/2014/06/20/sleep-position-health_n_5500859.html

New research suggests soluble corn fibre may boost calcium absorption

Innovative ingredient may offer one solution for helping adolescents to improve status of two nutrients currently lacking in their diets

Hoffman Estates, IL – Around the globe, fibre and calcium intakes are below the levels recommended by experts^1,2,3 contributing to potential long-term public health implications^1,3,4. New research, published this month in theBritish Journal of Nutrition, shows soluble corn fibre (SCF) may not simply boost fibre intake when added to foods, but can also increase the amount of beneficial bacteria present in the gut, while enhancing calcium absorption in adolescents⁵. SCF is a prebiotic fibre that is well tolerated, and is easily incorporated into foods or beverages to boost fibre content. These latest results showing SCF can enhance calcium absorption are significant because during adolescence, a critical time for bone growth, dairy intake tends to decrease, resulting in inadequate calcium intake which is a vital mineral for building and maintaining strong bones.
Researchers studied the potential effect of SCF on calcium absorption and retention in adolescent children with a usual diet that was low in fibre. In a controlled dietary study, adolescent girls and boys who consumed 12g/day fibre from SCF absorbed significantly more calcium (a 12% increase versus a control) than when consuming no SCF. Additionally, the researchers found that when the adolescents consumed SCF, there was an increase in specific strains of beneficial gut bacteria, namely the phylum Bacteroidetes, and these increases were positively correlated with increases in calcium absorption. These results indicate that moderate daily intake of SCF may increase beneficial gut bacteria and also short-term calcium absorption in adolescents who are consuming less than recommended amounts of calcium.
'A decrease in milk consumption among adolescents has led to an increase in deficiency of calcium in the diet, leaving researchers with a particular interest in finding functional foods that can help increase calcium absorption,' stated Connie Weaver, PhD, of Purdue University and lead researcher of the study. 'Dietary factors that enhance bone density and bone mineral content have the potential to contribute to reduced risk of bone fracture later in life.'
If the adolescents in this study had continued to consume SCF, allowing for increased calcium absorption, the researchers estimated that this would lead to additional 41.4 mg/day retained calcium and if persistent over a year would account for an additional 15.1 g of calcium, or about 1.8% of total body calcium.
'On average, people aren't meeting their fibre or calcium intake goals with the foods they currently consume. Adding fibres with functional health benefits to already consumed foods is a realistic and simple way to help address this global public health concern among key age groups,' said Michael Harrison, PhD, Senior Vice President of New Product Development at Tate & Lyle. 'Tate & Lyle has consistently shown a commitment to investing in research that leads to the production of high quality ingredients that allow people to live well and improve their health.'

 

The soluble corn fibre used in the study was added to fruit snacks and provided by Tate & Lyle, a global provider of high-quality, specialty ingredients.

References ¹ U.S. Department of Agriculture and U.S. Department of Health and Human Services. Report of the Dietary Guidelines Advisory Committee on the Dietary Guidelines for Americans, 2010.http://www.cnpp.usda.gov/dgas2010-dgacreport.htm
² Spiller GA (ed.) CRC Handbook of Dietary Fiber in Human Nutrition, 3rd Edition. CRC Press LLC, Boca Raton, Fla. 2001.
³ Wang Y, Li S. Worldwide trends in dairy production and consumption and calcium intake: Is promoting consumption of dairy products a sustainable solution for inadequate calcium intake? Food Nutr Bull. 2008;29:172.
⁴ Fulgoni VL, Keast DR, Auestad N, Quann EE. Nutrients from dairy foods are difficult to replace in diets of Americans: food pattern modeling and an analyses of the National Health and Nutrition Examination Survey 2003. Nutr Res. 2011;31:759–65.
⁵ Whisner CM, Martin BR, Nakatsu CH, McCabe GP, McCabe LD, Peacock M, Weaver CM. Soluble maize fibre affects short-term calcium absorption in adolescent boys and girls: a randomised controlled trial using dual stable isotopic tracers. Br J Nutr. 2014;112:446-456.

Weather Changes Not Responsible for Low Back Pain: Australian Study

An Australian study has now found out that weather may not play a significant role in the development of low back pain.Low Back Pain Causes 
Low back pain is a symptom that most of us have suffered at some point in our life. Common causes of low back pain are: 

• Bad posture: Besides a bad posture while sitting, low back pain may be also caused by awkward postures for prolonged durations. 

• Injury: Strains and sprains of the back may result in back pain 

• Disease conditions: Disease conditions affecting the lower back like osteoarthritis and osteoporosis can also cause back pain. 

Low Back Pain Exercises 
A number of cases of low back pain can be treated by strengthening the muscles of the back. These back exercises should be performed under the guidance of a trained physiotherapist. Patients with a disease condition affecting the back should take prior approval from their treating doctor before attempting such exercises. 

Many people feel that a change in the weather conditions causes back pain. An Australian study considered this aspect and published their finding in the journal Arthritis Care & Research. They recruited patients with first time back pain and checked if the back pain was associated with the weather conditions one week before and one month after the back pain appeared. 

The researchers found that weather conditions like temperature, humidity, air pressure, wind direction and precipitation were not associated with the appearance of low back pain. A small increase in incidence of back pain was noticed with higher wind speeds or wind gusts, but the results were not significant. 

However, the authors suggest that further studies will be required to study the influence of weather conditions on specific diseases affecting the back like fibromyalgia, rheumatoid arthritis and osteoarthritis. 

References: 
1. http://as.wiley.com/WileyCDA/PressRelease/pressReleaseId-111044.html 
 
 

Researchers Find New Route for Ovarian Cancer Spread

Circulating tumor cells spread ovarian cancer through the bloodstream, homing in on a sheath of abdominal fatty tissue where it can grow and metastasize to other organs.

Scientists at The University of Texas MD Anderson Cancer Center report this in Cancer Cell. "This completely new way of thinking about ovarian cancer metastasis provides new potential avenues to predict and prevent recurrence or metastasis," said senior author Anil Sood, M.D., professor of Gynecologic Oncology and Reproductive Medicine and Cancer Biology. 

The researchers found the circulating tumor cells (CTCs) rely on HER3, a less-famous sibling of the HER2 receptor protein prominent in some breast cancers, to find their way to the omentum, a sheet of tissue that covers and supports abdominal organs. 

HER3's heavy presence on these cells makes it a biomarker candidate and suggests possible therapeutic options to thwart ovarian cancer progression, the researchers noted. "The CTCs are not just a correlation, they seem to have a functionally important role in metastasis," Sood said. 

High expression of HER3 in ovarian cancer tumors is associated with shorter survival, the team found. 

Ovarian cancer has been thought mainly to spread via direct surface contact with neighboring organs in the abdominal cavity. "However, it also metastasizes to more distant organs such as the liver and spleen, which seems to indicate arrival through the bloodstream," Sood said. 

Ovarian tumor cells are found abundantly in the blood vessels of the omentum and CTCs are present in ovarian cancer patients. However the importance of CTCs was not well understood. 

Two mice, one blood supplyThe researchers used a parabiosis mouse model, in which two mice are joined at the skin from hip to shoulder. They share blood supply but not lymphatic vessels. "This was the most convincing way to prove that CTCs play a role in metastasis," said first author Sunila Pradeep, Ph.D., instructor of Gynecologic Oncology and Reproductive Medicine. 

When the host mouse of each pair was injected with ovarian cancer cells, a primary tumor developed and metastases were found in the omenta of all of the host mice. In the guest mice, metastatic cells and tumors appeared first in the omentum before spreading to other organs. 

The team compared gene expression in tumors between the original ovarian cancer cell line and its metastatic version found in the omentum. 

Expression of HER3, also known as ERBB3, was highly elevated and activated. The binding protein, or ligand, most likely to cause that activation is NRG1, which was found abundantly on the metastatic cells. 

More than 95 percent of CTCs collected from mice with the metastatic version of ovarian cancer were HER3-positive. The more HER3-positive cells the mice had, the greater the tumor burden. 

HER3 expression reduces human survivalIn tumor samples from 11 ovarian cancer patients, 90 percent of cells were HER3-positive. Tumor cells found in the omental blood vessels of five patients analyzed also had strong HER3 expression. 

In a cohort of 217 advanced-stage patients, lower HER3 expression correlated with improved overall survival of 4.9 years compared to 3.15 years for high-HER3 tumors. 

Analyzed by itself, HER3 expression was significantly associated with advanced-stage disease at diagnosis. When other variables such as the patient's age, disease stage and tumor grade were controlled for, HER3 expression remained an independent factor for patient survival. They also found: 

HER3 expression to be significantly higher in human stage 3 and 4 tumors compared to stage 1 and 2 tumors.
Blocking HER3 with siRNA significantly lowered expression of the protein, decreased tumor growth and reduced metastasis in mice.
Plugging HER3 with the antibody MM-121 reduced the size and number of tumors and frequency of metastasis in treated mice to a tiny fraction of that found in control mice.
Results were repeated with additional high-grade serous ovarian cancer and colon cancer models.
NRG1 in omentum draws in circulating tumor cellsExperiments showed knocking down HER3 in cancer cell lines in the lab did not have the same effect as it did in the mice. This led the researchers to suspect something present in the omentum microenvironment caused the cancer's dependency on HER3. 

The binding ligand NRG1 is more abundant in the omentum than in other tissues. The team found: 

Colonies of cancer cells treated with NRG1 were triple the size of untreated tumor cell colonies.
Analysis of 11 human tumors found NRG1 evident both in the tumors and the microenvironment.
Blocking NRG1 with siRNA in mice with ovarian cancer significantly reduced metastasis.
"The NRG1 ligand expressed in the omentum attracts HER3-positive CTCs," Sood said. 

The next steps for the team are to further flesh out the details and understand opportunities to intervene in this cancer-spreading process. The findings provide a rational route to develop new drugs, Sood noted. 

Potential uses include using HER3-positive cells as a biomarker for recurrence for patients or for occurrence in women at high-risk for developing ovarian cancer. Maintenance anti-HER3 therapy after treatment could prevent metastasis to the omentum. 

Clinical trials are under way for pertuzumab, an antibody that blocks HER2, to explore whether it might thwart both proteins in ovarian and breast cancer. HER2 and HER3 are members of the epidermal growth factor receptor family of receptor tyrosine kinase proteins.
 Source:The University of Texas MD Anderson Cancer Center 

 

Novel Compound Treats Both Blindness and Diabetes in Animal Studies

A chemical compound discovered by scientists treats both blindness and diabetes in rats and mice.

  In addition to opening a promising drug-development path for the wide range of diseases caused by cell loss, the new research offers a new view of the workings of the unfolded protein response (UPR), a cellular "life-or-death" signaling network: When cells are under stress, the UPR works to ensure that they produce properly configured proteins, but those cells not up to this task are quickly prompted by the UPR to self-destruct. 

A component of the UPR known as the IRE1 pathway has generally been thought to handle the protective aspects of this response, promoting cell survival by providing cells with the biological resources they need to cope with stress, while a complementary pathway, called PERK, has been associated with cell death. 

But in the new research, published in the July 10, 2014 edition of Cell, when researchers used KIRA6, a small-molecule kinase inhibitor they designed to inhibit the actions of IRE1 alpha —the molecular sensor that triggers the IRE1 pathway—they blocked cell death and preserved function in experimental models of two human diseases. 

In two rat models of retinitis pigmentosa, a disease in which light-sensing cells in the eye progressively die off, causing blindness, KIRA6 preserved both the number of these cells and visual function. And in mice from a strain known as Akita, which carry a genetic mutation that causes diabetes in early life as stressed insulin-producing beta cells of the pancreas degenerate, KIRA6 protected beta cells from cell death, leading to a two-fold increase in insulin production and improving blood glucose control. 

"This is a huge advance in our field," said co-senior author Scott A. Oakes, MD, associate professor of pathology at UCSF. "On the surface these would seem to be two very different diseases, but IRE1-induced cell death is at the root of both of them." 

The results are the culmination of "a gigantic project," first to establish that the IRE1 pathway could drive degenerative disease, and then to design and test compounds to head off the damage, said UCSF's Feroz Papa, MD, PhD, associate professor of medicine and co-senior author, and a member of the California Institute for Quantitative Biosciences. "It took four years, over a hundred separate experiments in various contexts—not counting replications—and involved 24 researchers working in seven labs labs across four cities." 

KIRA6 is the latest in a series of compounds (the acronym stands for "Kinase-Inhibiting RNase Attenuators) that were originally designed and synthesized in the labs of study co-authors Dustin J. Maly, PhD, associate professor of chemistry at The University of Washington, Seattle, and Bradley J. Backes, PhD, associate professor of medicine at UCSF. 

"While KIRA6 showed efficacy in animals," said Papa, "it is important to stress that more optimization through medicinal chemistry efforts is needed to develop this class of compounds to the stage where they could be tested for efficacy in humans through clinical trials." 

Oakes and Papa said that support from the Cleveland, Ohio-based Harrington Discovery Institute was crucial to sustaining this complex collaboration. Both scientists were 2013 winners of Scholar-Innovator Awards from the Institute, which is part of The Harrington Project for Development and Discovery a $250 million national model to accelerate the development of medical breakthroughs by physician-scientists into medicines that benefit patients. Other critical support for the work came from the National Institutes of Health, the Juvenile Diabetes Research Foundation, the Burroughs Wellcome Fund, the American Cancer Society, and the Howard Hughes Medical Institute.
 Source:Cell

Teenaged Nepali Girl Gives Birth to Child

It has emerged that a 13-year-old girl in Nepal's Chitwan District gave birth to a child at Bharatpur Hospital recently. 

One Chandra Bahadur Chhetri of Kathar, Chitwan, reportedly raped the girl before she became pregnant.

 

According to Nepal News, police have taken Chhetri into custody for investigation. 

The girl and her newborn were said to be normal.
 Source:News Agency of Nepal

Smell and eye tests show potential to detect Alzheimer's early

New Alzheimer's biomarker results reported at Alzheimer's Association International Conference 2014

COPENHAGEN, July 13, 2014 – A decreased ability to identify odors might indicate the development of cognitive impairment and Alzheimer's disease, while examinations of the eye could indicate the build-up of beta-amyloid, a protein associated with Alzheimer's, in the brain, according to the results of four research trials reported today at the Alzheimer's Association International Conference® 2014 (AAIC® 2014) in Copenhagen.
In two of the studies, the decreased ability to identify odors was significantly associated with loss of brain cell function and progression to Alzheimer's disease. In two other studies, the level of beta-amyloid detected in the eye (a) was significantly correlated with the burden of beta-amyloid in the brain and (b) allowed researchers to accurately identify the people with Alzheimer's in the studies.
Beta-amyloid protein is the primary material found in the sticky brain "plaques" characteristic of Alzheimer's disease. It is known to build up in the brain many years before typical Alzheimer's symptoms of memory loss and other cognitive problems.
"In the face of the growing worldwide Alzheimer's disease epidemic, there is a pressing need for simple, less invasive diagnostic tests that will identify the risk of Alzheimer's much earlier in the disease process," said Heather Snyder, Ph.D., Alzheimer's Association director of Medical and Scientific Operations. "This is especially true as Alzheimer's researchers move treatment and prevention trials earlier in the course of the disease."
"More research is needed in the very promising area of Alzheimer's biomarkers because early detection is essential for early intervention and prevention, when new treatments become available. For now, these four studies reported at AAIC point to possible methods of early detection in a research setting to choose study populations for clinical trials of Alzheimer's treatments and preventions," Snyder said.
With the support of the Alzheimer's Association and the Alzheimer's community, the United States created its first National Plan to Address Alzheimer's Disease in 2012. The plan includes the critical goal, which was adopted by the G8 at the Dementia Summit in 2013, of preventing and effectively treating Alzheimer's by 2025. It is only through strong implementation and adequate funding of the plan, including an additional $200 million in fiscal year 2015 for Alzheimer's research, that we'll meet that goal.  
Clinically, at this time it is only possible to detect Alzheimer's late in its development, when significant brain damage has already occurred. Biological markers of Alzheimer's disease may be able to detect it at an earlier stage. For example, using brain PET imaging in conjunction with a specialized chemical that binds to beta-amyloid protein, the buildup of the protein as plaques in the brain can be revealed years before symptoms appear. These scans can be expensive and are not available everywhere. Amyloid can also be detected in cerebrospinal fluid through a lumbar puncture where a needle is inserted between two bones (vertebrae) in your lower back to remove a sample of the fluid that surrounds your brain and spinal cord.
Greater Neurodegeneration Associated with Worse Olfactory Function in Cognitively Normal Elderly
There is growing evidence that the decreased ability to correctly identify odors is a predictor of cognitive impairment and an early clinical feature of Alzheimer's. As the disease begins to kill brain cells, this often includes cells that are important to the sense of smell.
Matthew E. Growdon, B.A., M.D./M.P.H. candidate at Harvard Medical School and Harvard School of Public Health, and colleagues investigated the associations between sense of smell, memory performance, biomarkers of loss of brain cell function, and amyloid deposition in 215 clinically normal elderly individuals enrolled in the Harvard Aging Brain Study at the Massachusetts General Hospital. The researchers administered the 40-item University of Pennsylvania Smell Identification Test (UPSIT) and a comprehensive battery of cognitive tests. They also measured the size of two brain structures deep in the temporal lobes – the entorhinal cortex and the hippocampus (which are important for memory) – and amyloid deposits in the brain.
At AAIC 2014, Growdon reported that, in this study population, a smaller hippocampus and a thinner entorhinal cortex were associated with worse smell identification and worse memory. The scientists also found that, in a subgroup of study participants with elevated levels of amyloid in their brain, greater brain cell death, as indicated by a thinner entorhinal cortex, was significantly associated with worse olfactory function – after adjusting for variables including age, gender, and an estimate of cognitive reserve.
"Our research suggests that there may be a role for smell identification testing in clinically normal, older individuals who are at risk for Alzheimer's disease," said Growdon. "For example, it may prove useful to identify proper candidates for more expensive or invasive tests. Our findings are promising but must be interpreted with caution. These results reflect a snapshot in time; research conducted over time will give us a better idea of the utility of olfactory testing for early detection of Alzheimer's."
The Harvard Aging Brain Study is funded by the U.S. National Institute on Aging and the Alzheimer's Association.
Odor Identification Deficits Linked with Transition from Mild Cognitive Impairment to Alzheimer's
Davangere Devanand, M.B.B.S., M.D., Professor of Psychiatry (in Neurology and in the Sergievsky Center) at Columbia University Medical Center and colleagues investigated a multi-ethnic (34% White, 30% African-American, 36% Hispanic) sample of 1037 non-demented elderly people in New York City, with an average age of 80.7, and assessed them in a variety of ways at three time periods – from 2004-2006, 2006-2008, and 2008-2010. UPSIT was administered in English and Spanish between 2004 and 2006. During follow-up 109 people transitioned to dementia (101=Alzheimer's); there were 270 deaths.
At AAIC 2014, Devanand reported that, in 757 subjects who were followed, lower odor identification scores on UPSIT were significantly associated with the transition to dementia and Alzheimer's disease, after controlling for demographic, cognitive, and functional measures, language of administration, and apolipoprotein E genotype. For each point lower that a person scored on the UPSIT, the risk of Alzheimer's increased by about 10%. Further, lower baseline UPSIT scores, but not measures of verbal memory, were significantly associated with cognitive decline in participants without baseline cognitive impairment.
"Odor identification deficits were associated with the transition to dementia and Alzheimer's disease, and with cognitive decline in cognitively intact participants, in our community sample. The test was effective in both English and Spanish," said Devanand. "If further large-scale studies reproduce these results, a relatively inexpensive test such as odor identification may be able to identify subjects at increased risk of dementia and Alzheimer's disease at a very early stage, and may be useful in identifying people at increased risk of cognitive decline more broadly."
Eye Exam for Beta-Amyloid Correlates with Levels in the Brain and Detects People with Alzheimer's
Recent studies have identified beta-amyloid plaques in the retinas of people with Alzheimer's – similar to those found in the brain – suggesting the possibility of simple, non-invasive methods of early detection.
At AAIC 2014, Shaun Frost of the CSIRO (Commonwealth Scientific and Industrial Research Organization, Australia) and colleagues reported preliminary results of a study of volunteers who took a proprietary supplement containing curcumin, which binds to beta-amyloid with high affinity and has fluorescent properties that allow amyloid plaques to be detected in the eye using a novel system from NeuroVision Imaging, LLC, and a technique called retinal amyloid imaging (RAI). Volunteers also underwent brain amyloid PET imaging to correlate the retina and brain amyloid accumulation.
An abstract prepared by the scientists for AAIC 2014 gives the results for 40 participants out of 200 total in the study. The full study is expected to be completed later this year.
Preliminary results suggest that amyloid levels detected in the retina were significantly correlated with brain amyloid levels as shown by PET imaging. The retinal amyloid test also differentiated between Alzheimer's and non-Alzheimer's subjects with 100 percent sensitivity and 80.6 percent specificity.
Furthermore, longitudinal studies on an initial cohort demonstrated an average of 3.5% increase in retinal amyloid over a 3.5-month period of time demonstrating promise of the technique as a means for monitoring response to therapy.
"We envision this technology potentially as an initial screen that could complement what is currently used: brain PET imaging, MRI imaging, and clinical tests," Frost said. "If further research shows that our initial findings are correct, it could potentially be delivered as part of an individual's regular eye check-up. The high resolution level of our images could also allow accurate monitoring of individual retinal plaques as a possible method to follow progression and response to therapy."
The trial is a collaboration between CSIRO, Edith Cowan University, McCusker Alzheimer's Research Foundation and California-based NeuroVision Imaging. The project is part of the Australian Imaging and Biomarkers Lifestyle Study of Aging (AIBL).
Amyloid Detected in the Lens of the Eye Strongly Correlates to Amyloid Levels Detected in the Brain
At AAIC 2014, Paul D. Hartung, M.S, President and CEO of Cognoptix, Inc. and colleagues reported the results of a study of a novel fluorescent ligand eye scanning (FLES) system that detects beta-amyloid in the lens of the eye using a topically-applied ointment that binds to amyloid and a laser scanner.
The researchers studied 20 people with probable Alzheimer's disease, including mild cases, and 20 age-matched healthy volunteers; all participants' Alzheimer's status was masked from the observers. The ointment was applied to the inside of participants' lower eyelids the day before measurement. Laser scanning detected beta-amyloid in the eye by the presence of a specific fluorescent signature. Brain amyloid positron emission tomography (PET) scanning was performed on all participants to estimate amyloid plaque density in the brain.
Using results from the fluorescent imaging, researchers were able to differentiate people with Alzheimer's from healthy controls with high sensitivity (85 percent) and specificity (95 percent). In addition, amyloid levels based on the eye lens test correlated significantly with results obtained through PET brain imaging. No serious adverse events were reported, according to the scientists.
"There is a critical need for a fast, dependable, low-cost and readily available test for the early diagnosis and management of Alzheimer's disease," said Pierre N. Tariot, M.D., Director of the Banner Alzheimer's Institute in Phoenix, and a principal investigator in the study.

"The results of this small Phase 2 feasibility study validate our previously reported results and demonstrate the ability of the FLES system to reproduce the findings of clinical diagnosis of Alzheimer's with high sensitivity and specificity," said Hartung. "This system shows promise as a technique for early detection and monitoring of the disease."
Source:Alzheimer's Association International Conference

Stanford researchers invent nanotech microchip to diagnose type-1 diabetes

An inexpensive, portable, microchip-based test for diagnosing type-1 diabetes could improve patient care worldwide and help researchers better understand the disease, according to the device's inventors at the Stanford University School of Medicine.
Described in a paper to be published online July 13 in Nature Medicine, the test employs nanotechnology to detect type-1 diabetes outside hospital settings. The handheld microchips distinguish between the two main forms of diabetes mellitus, which are both characterized by high blood-sugar levels but have different causes and treatments. Until now, making the distinction has required a slow, expensive test available only in sophisticated health-care settings. The researchers are seeking Food and Drug Administration approval of the device.
"With the new test, not only do we anticipate being able to diagnose diabetes more efficiently and more broadly, we will also understand diabetes better - both the natural history and how new therapies impact the body," said Brian Feldman, MD, PhD, assistant professor of pediatric endocrinology and the Bechtel Endowed Faculty Scholar in Pediatric Translational Medicine. Feldman, the senior author of the paper, is also a pediatric endocrinologist at Lucile Packard Children's Hospital Stanford.
Better testing is needed because recent changes in who gets each form of the disease have made it risky to categorize patients based on their age, ethnicity or weight, as was common in the past, and also because of growing evidence that early, aggressive treatment of type-1 diabetes improves patients' long-term prognoses. Decades ago, type-1 diabetes was diagnosed almost exclusively in children, and type-2 diabetes almost always in middle-aged, overweight adults. The distinction was so sharp that lab confirmation of diabetes type was usually considered unnecessary, and was often avoided because of the old test's expense and difficulty. Now, because of the childhood obesity epidemic, about a quarter of newly diagnosed children have type-2 diabetes. And, for unclear reasons, a growing number of newly diagnosed adults have type-1.
Type-1 diabetes is an autoimmune disease caused by an inappropriate immune-system attack on healthy tissue. As a result, patients' bodies stop making insulin, a hormone that plays a key role in processing sugar. The disease begins when a person's own antibodies attack the insulin-producing cells in the pancreas. The auto-antibodies are present in people with type-1 but not those with type-2, which is how tests distinguish between them.
A growing body of evidence suggests that rapid detection of, and aggressive new therapies for, type-1 diabetes benefit patients in the long run, possibly halting the autoimmune attack on the pancreas and preserving some of the body's ability to make insulin.
The old, slow test detected the auto-antibodies using radioactive materials, took several days, could only be performed by highly-trained lab staff and cost several hundred dollars per patient. In contrast, the microchip uses no radioactivity, produces results in minutes, and requires minimal training to use. Each chip, expected to cost about $20 to produce, can be used for upward of 15 tests. The microchip also uses a much smaller volume of blood than the older test; instead of requiring a lab-based blood draw, it can be done with blood from a finger prick.
The microchip relies on a fluorescence-based method for detecting the antibodies. The team's innovation is that the glass plates forming the base of each microchip are coated with an array of nanoparticle-sized islands of gold, which intensify the fluorescent signal, enabling reliable antibody detection. The test was validated with blood samples from people newly diagnosed with diabetes and from people without diabetes. Both groups had the old test and the microchip-based test performed on their blood.
In addition to new diabetics, people who are at risk of developing type-1 diabetes, such patients' close relatives, also may benefit from the test because it will allow doctors to quickly and cheaply track their auto-antibody levels before they show symptoms. Because it is so inexpensive, the test may also allow the first broad screening for diabetes auto-antibodies in the population at large.
"The auto-antibodies truly are a crystal ball," Feldman said. "Even if you don't have diabetes yet, if you have one auto-antibody linked to diabetes in your blood, you are at significant risk; with multiple auto-antibodies, it's more than 90 percent risk."
Type-1 diabetes patient Scott Gualdoni of Palo Alto, Calif., and his 9-year-old daughter, Mia, are excited about the new test. Gualdoni was diagnosed with diabetes in 2011, at age 41. Because of his age, his primary care physician began treating him for type-2 diabetes without testing him for auto-antibodies.
After a few months, Gualdoni returned to his doctor and asked for an antibody test. "I was just feeling like something wasn't right," he said. His suspicions were confirmed: He had type-1.
"Doctors may not be thinking adults can get late-onset type-1," he said. "I slipped through the cracks." He's eager to see the microchip test implemented because a cheap handheld test in the doctor's office would have saved him months of incorrect treatment. "If you're not treating the right disease, you're really doing damage to your body," he said.
The test also holds promise for Mia, who was found to have five kinds of diabetes auto-antibodies in her blood when she volunteered for TrialNet, a nationwide study that tracks relatives of people with type-1 diabetes to monitor their risk.
"I'm really excited for other people who are at high risk for diabetes that this new technology is available for them now," Mia said.
"There is great potential to capture people before they develop the disease, and prevent diabetes or prevent its complications by starting therapy early," Feldman said. "But the old test was prohibitive for that type of thinking because it was so costly and time-consuming."
Stanford University and the researchers have filed for a patent on the microchip, and the researchers also are working to launch a startup company to help get the method approved by the FDA and bring it to market, both in the United States and in parts of the world where the old test is too expensive and difficult to use.

"We would like this to be a technology that satisfies global need," Feldman said.

Source:Nature Medicine