PRAMIPEXOLE CLINICAL TRIAL RESULTS IN PARKINSON'S DISEASE

20th May 2014 - New research

Barone, Y.Mizuno, O.Rascol, M.Busse, C.Debieuvre, M.Fraessdorf, W.Poewe
European Journal of Neurology [2014] 21 (5) : 736-743 (R.A.Hauser, A.H.Schapira, P.

Barone,Complete abstract : http://www.ncbi.nlm.nih.gov/pubmed/24834511

The long term safety and efficacy of pramipexole was assessed as an extended-release oral

formulation and immediate release formulation in early or advanced Parkinson's Disease.

Pramipexole, which is marketed as Mirapex, Mirapexin, and Sifrol, is a dopamine agonist.

For more information go to Pramipexole : http://www.rxlist.com/mirapex-drug.htm

In those people with early Parkinson's Disease the reported side

effects were somnolence (15%), peripheral edema (11%) and back

pain (10%). The scores on the Parkinson's Disease symptom score

(UPDRS) after over 2 years were down by 6.6 when using extended

release pramipexole and 6.3 when using immediate release

pramipexole. In those people with advanced Parkinson's Disease the

reported side effects were dyskinesia (27%), somnolence (13%),

and impulse control disorders (1%). The scores on the Parkinson's

Disease symptom score (UPDRS) after over 2 years were down by

11.5 when using extended release pramipexole and 9.1 when using

immediate release pramipexole.

In both early and advanced Parkinson's Disease better efficacy was achieved when using the

extended release version of pramipexole. The adverse events were typical for dopaminergic

drugs.

©2014 Viartis

Upcoming Challenges for Neurologists in the United States

With the rapidly changing economy, new healthcare laws, and a plethora of cuts from the government, neurologists and their practices should expect a severe decrease in revenue. According to JAMA Neurology Volume 70, Number 9, the sweeping changes due to Obamacare are effecting many medical institutions and practices, but for a number of reasons, neurology is in a crisis of its own. To give you an idea of impact of current neurological practices, here are some of the big cuts that’ve already been implemented:

"...as of January 1, 2013, the Centers for Medicare and Medicaid Services, by regulation, reduced the payment for nerve conduction testing services by more than 50%. Jonathan Blum, a Centers for Medicare and Medicaid Services administrator, indicated that these cuts reduce total neurologic revenue by 7% on average. Implemented March 1, 2013, sequestration cuts further reduced Medicare payments to physicians by 2%. Because the typical neurologic practice has an overhead percentage of greater than 50%, the 9% cut to revenue translates to a greater than 18% reduction in neurologist income.”
…"every deficit reduction proposal targets GME payments. The most prominent, the 2010 Simpson/Bowles bipartisan commission (updated in 2012), proposed a 60% reduction in GME payments. President Barack Obama’s recently released 2014 budget recommends a $780 million cut to GME payments, approximately a 7% cut."

Not only are current small neurology practices being short-changed, but those looking to train to become neurologists are also in trouble:

"As neurologic practices struggle to stay afloat, the viability of training programs is also imperiled. In addition to the loss of clinical revenues, 2 other sources of revenue that support the educational mission are at risk: hospital facility fees and federal graduate educational payments. The facility fee—an additional charge for outpatient services charged by hospitals that materially adds to the reimbursement for these services—is on the hit list for deficit reduction."

As if these cuts weren’t enough, research grants will also be greatly reduced:

”...new grants are projected to be sharply reduced to 17% to 18% of the proposals. Successful awardees now comprise only half of the percentage of those who succeeded in attaining them in the 1980s.”
“…Academic and research programs can find replacement for some of the lost federal revenues through well-coordinated efforts to attract charitable support.”
“...GME funding of neurology training must be protected. Finally, the president’s announced initiative provides a key opportunity to educate the public and Congress as to the need for research and access to care for this patient population.”

Unfortunately in rough economic times, science and medicine tend to get defunded. Neurological disorders are prevalent throughout the world, and as a society we understand that they need serious research and treatments. In your next email, letter, or call to your representatives, consider pressuring them to support laws that strengthen neurological science, treatments, and practices.

Visit JAMA Neurology’s site to susbcribe to their journal for further reading and sources. JAMA Neurology September 2013 Volume 70, Number 9 page 1097, 1098 written by Orly Avitzur, MD, MBA and Bruce Sigsbee, MD, MS.

A Finger Sensor & App could make Parkinson’s disease Symptom Monitoring more Scalable

April 16, 2014 

Thanks in part to a $1.5 million grant from NIH, Great Lakes Neurotechnologies thinks it can make its Parkinson’s disease symptom monitoring technology more scalable and flexible by taking it mobile.

GLN makes the FDA-cleared Kinesia technology platform, which uses a patient-worn sensor and PC tablet-based software to quantify and monitor motor-related symptoms of Parkinson’s. While it’s found traction in the clinical trials market with companies developing new treatments for Parkinson’s, the company says the price point has kept it from widespread use in traditional patient care.

The current system comprises a sensor device that a patient with Parkinson’s disease wears on his finger as he performs tasks. Along with the sensor, the patient kit includes a tablet with broadband connectivity that instructs the patient through assessments, collects data from the sensors and pushes data to the cloud. Via a web portal, clinicians can access reports on patients’ progress.

The app should be available by the end of 2014 in the U.S. and Europe, Cleveland-based GLN said.side from use in monitoring disease progression and evaluating how new therapies affect clinical trial participants’ Parkinson’s systems, the Kinesia system can also help neurologists fine-tune the settings of deep brain stimulation devices after they’ve been implanted. The sensor captures linear acceleration and angular velocities, and clinically validated algorithms in GLN’s software turn them into scores that can help clinicians gauge the severity of a tremor at a given time more: http://medcitynews.com/2014/04/remote-monitoring-parkinsons-disease-symptoms/#ixzz32da3dhPF

By Deanna Pogorelc MedCity News

"LIFT” SPOON NOT JUST FOR CONVENIENCE

 

Lift Labs, a San Francisco based business, developed the “Lift” spoon basically to enable people with movement disorders and tremors to eat comfortably without spilling their “soup” before getting it from the bowl to their mouth.  The device senses a tremor when it is first picked up and uses stabilizers to counter the tremor, keeping the contents of the spoon steady.  It has a rechargeable battery so it will always be ready to use.  Lift Labs is promising more attachments beside the spoon, such as a fork and a key holder will be available soon.

Now a young researcher from the University of Michigan, Dr. Kelvin L. Chou, has found that the “spoon” is not just convenient, but actually helps reduce tremors.   This clever fellow tested 15 PARKINSON’S DISEASE patients on three different tasks: holding something in the spoon; eating with the spoon and transferring objects from the spoon to a cup about a foot away.  (He actually used small foam blocks instead of actual food.)  Subjects were tested with the “spoon” turned off and then again with it turned on.  While both subjects and the investigator were supposedly blinded, because of the effect of the device, true blinding might not be possible.

With the exception of two subjects hose tremors were so severe that use of the device was not helpful, the rest saw a reduction of their tremors of between 71% and 76% as measured with an accelerometer.  Using the Fahn-Tolosa-Marin Tremor Rating Scale (TRS), all subjects showed a significant improvement on all three tasks when the device was turned on.  Improvement in this case meant going from “spilling to minimal spilling”.  Tremor was still present, but most of the subjects were impressed with the device and wanted to buy one when it becomes commercially available.

The device, called the Lift Ware Stabilizer, is now available and can be ordered from liftlabsdesign.com.  It costs $295.00, but comes with a 30-day money back guarantee.  Lift Labs says the cost works out to about 27 cents a meal for a year.
Handheld Device Reduced Tremors. Medscape. Mar. 11, 2014 
Review by Marcia McCallPicture Credit

http://patentsforhumanity.challengepost.com/submissions/9703-lift-system

http://designtaxi.com/news/362838/Top-10-Most-Future-Forward-Ideas-Of-2013/

http://virgula.uol.com.br/lifestyle/comportamento/cientistas-e-engenheiros-criam-colher-que-reduz-tremores-de-pacientes-de-parkinson

 

 

GENETICS OF PARKINSON’S DISEASE IS TOPIC OF NEW RESEARCH

 

The Parkinson’s Progression Markers Initiative  (PPMI) is an ongoing study looking for biomarkers in biological samples and imaging data from an international base of people with Parkinson’s disease who are part of a large national study.  Presently, over 800 individuals are involved with PPMI clinical trials at 32 sites.  In looking for biomarkers, such as a particular blood substances, or other physical processes that might predict the risk of PARKINSON’S DISEASE, researchers are hoping to find ways and means to both predict and treat the disease as early as possible and to target areas where drugs can be developed faster and more effectively.  Symptoms that have a demonstrated risk factor are loss of sense of smell and sleep behavior disorders are the subjects of other areas of research the PPMI. This study has already identified some blood markers such as the LRRK2 gene and the presence of alpha synuclein (SNCA gene) that are clearly connected to the disease, but the mechanism of operation is not yet clear.

Now they are further refining the search and are enrolling 250 subjects who are known to carry these genes and have symptoms of PARKINSON’S DISEASE and another 250 subjects who carry the genes but have no symptoms.  These subjects will be followed for at least 5 years.  At present, only about five or ten percent of all people with PARKINSON’S carry the genetic mutation.  However, knowledge learned from the genetics of these people will ultimately inform better understanding of the disease process. Of special interest are people of Eastern European descent who have relatives affected by PARKINSON’S DISEASE.

“Studying individuals with genetic mutations associated with PARKINSON’S can accelerate our research toward a PD biomarker and more effective treatments: said Stuart Factor, D.O., who is director of the Emory University Comprehensive Parkinson’s Disease Center and the director of the Emory Movement Disorders Center.  The large-scale extent of the PPMI research is already bringing scientific insights that will strengthen the efforts to find therapies that will modify or change the course of this disease.  This is an observational study that is seeking information and samples from participants.  Participants will not be involved in taking any experimental medication or undergoing any experimental procedures. Individuals who would like to be a part of this large undertaking should visit the Michael J. Fox Parkinson’s Progression Markers Initiative web page for further information.

 

http://medical express.com/news/2014-03-genetics-parkinson-disease.html

 

written by Marcia McCall

 

Picture Credits

http://www.sorensongenomics.com/public/uploads/1/2011/10/stock-photo-17000305-genetic-research-at-the-laboratory.jpg

http://i1.ytimg.com/vi/sJqKvajUC3k/maxresdefault.jpg

http://www2.fbi.gov/publications/leb/2010/august2010/images/confronting_feature_1.jpg

EARLY ASSESSMENT OF DEMENTIA RISK IN PARKINSON’S DISEASE

 

PARKINSON’S DISEASE is usually considered a “movement disorder”, with symptoms of tremor, rigidity and slowness that affect a person’s ability to move.  But a small percentage of people diagnosed with PARKINSON’S DISEASE go on to develop cognitive impairments, dementia or even Lewy body dementias.

“This study opens the door to further research, for example, on medication or on non-pharmacological approaches such as transcranial magnetic stimulation.  It’s important for these patients to be identified very quickly before they develop dementia so that a therapeutic approach can be adapted to their specific needs”, says Dr. Oury Monchi, the principal investigator of this study.

Dr. Monchi and Dr. Hanganu and their team of researchers affiliated with the Universitè de Montrèal, used magnetic resonance imaging to find there was a thinning and atrophy in some brain regions of people with mild cognitive impairment who were diagnosed in early stages of PARKINSON’S DISEASE.  They discovered that as the disease progressed, the thinning and atrophy of these areas progressed along with an increase in cognitive decline.  The study followed a cohort of 32 subjects in the early stages of PARKINSON’S DISEASE and a control group of 18 healthy subjects for a period of 20 months.

Cortical thinning has been proven to occur corresponding to the progression of the disease but has not been studied in relation to the development of cognitive impairment.  This study found a more rapid progression of thinning in the temporal, occipital, parietal and supplementary motor areas of patients with mild cognitive decline as compared to patients who had no cognitive impairments and healthy controls. They also found that the amygdala and nucleus accumbens also lost significant volume in patients with cognitive impairments. As a specific pattern of deterioration in these brain regions correlates to the presence of mild cognitive impairment in the early stages of PARKINSON’S DISEASE, these findings could lead to a biomarker predicting the subsequent development of dementia.

A. Hanganu, C. Bedetti, C. Degroot, B. Mejia-Constain, A.-L. Lafontaine, V. Soland, S. Chouinard, M.-A. Bruneau, S. Mellah, S. Belleville, O. Monchi. Mild cognitive impairment is linked with faster rate of cortical thinning in patients with Parkinson’s disease longitudinally. Brain, 2014; DOI:10.1093/brain/awu036

 

Review by Marcia McCall

 

Picture Credits

http://shop.cephalon.eu/Double%2070mm%20Remote%20Control%20Coil%20for%20Magstim%20stimul/ItemDetails.aspx?9=GB&5=MAG3190-00&11=1775

http://www.dailymail.co.uk/news/article-1217268/Dementia-immoral-neglect-Experts-blast-lack-Alzheimers-support.html

http://wordpress.greenwichacademy.org/gasciencetimes/?page_id=101

PREDICTING COGNITIVE DECLINE IN PD FROM ALPHA SYNUCLEIN IN CEREBRAL SPINAL FLUID

 

 

Predicting Cognitive Decline in PD from Alpha Synuclein in Cerebral Spinal Fluid

A new study being published in the April issue of the American Journal of Pathology has looked at data from 304 subjects from a study begun in 1987 that was one of the earliest studies that collected and catalogued specimens from early onset and newly diagnosed people with PARKINSON’S DISEASE and followed them for up to 8 years.  That study was the Deprenyl and Tocopherol Antioxidative Therapy of Parkinson’s (DATATOP) that found it possible to control symptoms and delay initiating treatment with levodopa by using Deprenyl.  It was a wide reaching study that led to a better understanding of the progression of the disease and the search to develop more neuroprotective therapies for PARKINSON’S DISEASE.

This new study was unique in that it drew on the data collected over a long period of time previously and did a new analysis of that information to find a connection to cognitive change or dementia related to levels of alpha synuclein found in samples of cerebral spinal fluid (CSF).  Levels of alpha synuclein in CSF were found to generally decrease as the disease progressed, but in some cases it was noted that higher levels of alpha synuclein were found in the CSF of subjects whose scores showed greater cognitive decline in the cognitive tests.  Subjects with more rapid cognitive also had relatively higher levels of alpha synuclein in their CSF.

The original study was divided into phases; Phase one was from entry into the study and Phase two started when the treatment with levodopa began.  All subjects enrolled in that study were in very early, untreated stages of PARKINSON’S DISEASE and without any symptoms of dementia. Cognitive testing was performed at entry and repeated every six months.  The United Parkinson’s Disease Rating Scale (UPDRS) cognitive testing section evaluated multiple aspects of cognition, including verbal learning, memory, visuospatial working memory and processing speed.  During Phase two cognitive changes became evident and were apparent across all sections of the cognitive testing. This data was carefully analyzed to control for age, sex, education, exposure to study drug and the actual dose of levodopa.

This research was done at the University of Washington (Seattle) School of Medicine, Department of Pathology under the direction of Jing Zhang, M.D., Ph.D.  First author is Tessandra Stewart, Ph.D.

“Cerebrospinal fluid alpha-synuclein predicts cognitive decline in Parkinson disease progression in the DATATOP cohort,” by Tessandra Stewart, Changqin Liu, Carmen Ginghina, Kevin C. Cain, Peggy Auinger, Brenna Cholerton, Min Shi, Jing Zhang, and the Parkinson Study Group DATATOP investigators (DOI:dx.doi.org/10.1016/j.ajpath.2013.12.007), The American Journal of Pathology, Volume 184, Issue 4 (April 2014)

 

Review by Marcia McCall

Picture Credit

http://www.telegraph.co.uk/health/healthnews/10029205/GPS-tags-for-dementia-patients.html

http://www.control.tfe.umu.se/Ian/CSF/

http://www.genengnews.com/gen-news-highlights/biogen-idec-picks-up-neurimmune-s-neurodegenerative-programs-for-32-5m/81244418/

AN ELECTRONIC PATCH TO SIMPLIFY TREATMENT

AN ELECTRONIC PATCH TO SIMPLIFY TREATMENT

 

An Electronic Patch to Simplify Treatment

Imagine that you get up one morning and don’t have to take a pill or count the hours until the next dose!  Imagine that the medication is delivered precisely and directly to your body according to your body’s actual state of need.  Such a delivery technique could smooth out all the peaks and valleys and keep PARKINSON’S DISEASE under control and your life running smoothly.  This dream is close, very close, to becoming a reality.

An international collaboration of scientists is working hard to make this dream a reality. The first step was idea of John Rogers, a materials scientist at the University of Illinois. He developed a membrane so thin that it could be combined with nano scale electronic semiconductors. Thus, the idea of “epidermal electronics” as a patch that could monitor various vital signs through the skin.

A Korean study in a lab at Seoul National University, headed by Dae-Hyeong Kim who is assistant professor in chemical and biological engineering also developed a thin patch that could monitor subtle tremors and release medication stored in nanoparticles and at the same time record all the data for retrieval later.  The work of the Korean Lab collaborated with a new company, called MC10, in Cambridge, MA that has been set up specifically to advance the concept of “stretchable electronics” that will further the development of the epidermal electronic patch. Rogers is a co-founder of this company along with Roozbeh Ghaffari.

In a paper recently published in Nature Nanotechnology, the researchers describe a device that is thin as a temporary tattoo making it virtually unnoticeable and as flexible as a stretchy band-aid.  This device will be composed of multiple layers of ultra thin membranes embedded with nanoscale sensors that can distinguish and measure the tremors of PARKINSON’S DISEASE from ordinary movements. It will also measure other vital signs, such as blood oxygen, temperature, and heart rate and store that data in a memory.  Ultimately, the data will be able to be down loaded to a smart phone or streamed directly to other communication devices, but that technology is still under development.  The patch could also contain unique medication delivery system where the medication is directly released into the skin as needed based on the data from the other systems.

This device is still in prototype form, and testing in humans is still a few years off.  It will take time to perfect the technology and obtain the necessary regulatory approvals.  While this group is currently targeting movement disorders such as PARKINSON’S DISEASE, other applications for this product could successfully treat diabetes or migraine headaches.  Drug delivery via a patch on the skin is not new.  What makes this research exciting is the addition of elements to monitor vitals and store or transmit that data while at the same time providing a controlled release of medication.  Mr. Ghaffari points out that this device can “take the epidermal electronics and couple it with memory on board and therapy. You can close the loop from diagnosis to therapy on a single patch.”

 Multifunctional wearable devices for diagnosis and therapy of movement disorders: Dae-Hyeong Kim, et al; Natur Nanotechnology (2014) doi:10.1038/nnano.2014.3
A Bandage That Senses Tremors, Delivers Drugs, and Keeps a Record; David Talbot; MIT Technology Review; April 1, 2014

Reports Released on Telehealth and Brain Exposure to Paint, Glue, Degreasers

The report describes the new telehealth opportunity, analyzes the benefits from telehealth, 

and examines the barriers to widespread adoption in the United States. It also proposes 

the following specific policy changes:

• Adopt a standard definition for telehealth,
• Establish a single, national license for telehealth providers,
• Create technology-neutral insurance payment policies,
• Promote interoperability among state prescription drug monitoring programs, and
• Fund research to continually improve the quality and lower the cost of telehealth programs.

To read the full report, click here.  

Brain May Never Fully Recover from Exposure to Paint, Glue, Degreasers
A study published in the May 13, 2014 print issue of Neurology, the medical journal of the 

American Academy of Neurology, found that people who are exposed to paint, glue, 

or degreaser fumes at work may experience memory and thinking problems in retirement, 

decades after their exposure.

The study involved 2,143 retirees from the French national utility company. Researchers 

assessed the workers’ lifetime exposure to chlorinated solvents, petroleum solvents, 

and benzene, and evaluated the timing of the last exposure and lifetime dosage. About 

26 percent of those participants were exposed to benzene, 33 percent to chlorinated solvents, 

and 25 percent to petroleum solvents.

Participants who were exposed to the various chemicals then took eight tests of their

 memory and thinking skills an average of 10 years after they had retired, when they were

 an average age of 66. About 59 percent of the participants showed memory and thinking

 impairment on one to three of the eight tests.

To learn more and read the full study, click here.

Date originally posted: May 16, 2014.