Welcome to Our Parkinson's Place
I copy news articles pertaining to research, news and information for Parkinson's disease, Dementia, the Brain, Depression and Parkinson's with Dystonia. I also post about Fundraising for Parkinson's disease and events. I try to be up-to-date as possible. I have Parkinson's diseases as well and thought it would be nice to have a place where updated news is in one place. That is why I began this blog.
I am not responsible for it's contents, I am just a copier of information searched on the computer. Please understand the copies are just that, copies and at times, I am unable to enlarge the wording or keep it uniformed as I wish. This is for you to read and to always keep an open mind.
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Saturday, November 14, 2015
Click on to watch video:
|Mayor Geno Martini|
SPARKS, Nev. (MyNews4.com & KRNV) -- "Everybody loves Geno," Sparks City Council member Ron Smith said. "When you think of Geno Martini and Sparks, they go together."
Many people in Sparks think Geno Martini is a one-in-a-million mayor, but he's also one of about a million people living with Parkinson's Disease in the United States. Mayor Martini received his diagnosis in 2012, but didn't announce it to the public until Friday.
"I didn't feel quite right, so I went to a neurologist," Martini said. "He took a look, did a few things, and 'you've got Parkinson's.'"
Parkinson's is a movement disease that affects a person's motor functions. "It's a progressive disease where you lose functions and things like that," Martini said. "I'm feeling pretty strong now and I'm still moving along and doing most stuff."
The 69-year-old is well aware of what his future likely holds. "It's a tough disease," he said. "My father died from Parkinson's, so I know how devastating it can be."
Sparks city staff just found out about their mayor's diagnosis a few days ago. "Geno is a tough guy," council member Ron Smith said. "If anybody can get through this, he'll get through it."
Smith said he and the other council members plan to support Martini however they can through his term. "We're there to support Geno with whatever he needs. We'll pick up the slack if he can't do it."
Mayor Martini said he plans to keep serving Sparks for the next three years. "Sooner or later, the Parkinson's will get to you," he said, "but I intend to keep pushing through and filling out my term until 2018."
He's still chipper," Smith said. The Sparks mayor's vibrant personality is reassuring his fellow staff. "He's still Geno. He's got a positive attitude and that's what it will take."
Martini said the disease isn't slowing him down too much yet.
"Parkinson's hasn't really stopped me from doing anything at all."
READ the full statement from Mayor Martini, below:
“I am one of more than a million Americans diagnosed with Parkinson’s disease. I was diagnosed with Parkinson’s in 2012. I have done my best to manage the matter privately, but have come to the realization that I now need to make this announcement. I feel great and remain strong and healthy and am continuing to receive great medical care from local physicians. While the disease has slowed me down a bit physically, I am committed to serving as Mayor through the end of my term (November 2018). I will remain engaged and involved in our community to enhance economic development and improve the quality of life for our residents. I am blessed to have a loving and supportive family, a first-rate dedicated staff at the City of Sparks, and to serve in the greatest job in the world. I love my hometown and its people, and I am grateful and overwhelmed for everyone’s love and support.”
Nov 12, 2015
BOISE, Idaho (KBOI) -- A Treasure Valley man could soon be a millionaire.
Richard Herdegen created a commercial for a Doritos competition and if he wins, he'll not only get the money but his ad will play during Super Bowl 50!
The commercial features a YMCA program called "Delay the Disease" that helps locals living with Parkinson's Disease and other neurological disorders.
Right now, Herdegen's video is one of the highest rated ads in the competition. Voting for the top 50 videos begins in January.If the commercial wins Herdegen says the money will go to a nonprofit for Parkinson's.
Friday, November 13, 2015
Parkinson's disease: A new tool for healthcare professionals aims to improve diagnosis and advance treatment
Thursday, November 12, 2015
The topic of glial derived neurotrophic factor (GDNF) — a protein that may prevent the loss of dopamine cells (and even regenerate those that are lost) — was first on the agenda. GDNF can’t be taken orally, so cells that continuously produce GDNF need to be implanted into the area of the brain where most dopamine cells are missing in Parkinson’s. Lars Wahlberg, MD, PhD, of biotech NsGene, Inc., explained how encapsulated cell therapy might make this possible. A Phase Ib safety study is planned for 2016.
Talk of symptomatic therapies was on optogenetics — combining light (“optics”) and genetics to treat Parkinson’s motor symptoms. Christopher Moore, PhD, Brown University, reminded us how cells communicate with each other — through electrical signals created by the opening and closing of ion (calcium, sodium, etc.) channels. Optogenetics allows scientists to place a light-sensitive channel inside nerve cells and then open or close that channel with light. Optogenetics is currently being studied in pre-clinical models and shows potential for lessening motor symptoms.
The presentation on research tools focused on finding imaging biomarkers (disease indicators) for cognitive (memory and thinking) problems in Parkinson’s. Kathleen Poston, MD, MS, Stanford University, spoke about how today’s clinical trials call for multiple tests (which can be costly and time-consuming) to look for patterns of cognitive problems. She and her colleagues wanted to see if a single test — a “resting state functional MRI,” which examines the brain while a person is relaxed — could replace all of them and accurately diagnose cognitive difficulties in PD. Their study results are currently being analyzed.
Parkinson’s Progression Markers Initiative “Super Session”
Five years into The Parkinson’s Progression Markers Initiative (PPMI) — MJFF’s landmark observational study to find PD biomarkers — the Principal Investigator, Ken Marek, MD, gave an update on how the number and types of participants has expanded, and the categories of valuable data these volunteers are contributing. Researchers reviewed what they’ve concluded thus far from PPMI imaging and genetics information. John Seibyl, MD, The Institute for Neurodegenerative Disorders, talked about why measuring PD with a brain scan is hard — the disease course is slow and variable — and why imaging might therefore not be the only biomarker for Parkinson’s. Andrew Singleton, PhD, agreed, saying, “We’re having a maturing view of Parkinson’s disease that it’s more than one disease, so we may need more than one biomarker to track it.” Dr. Singleton went on to discuss how analysis of PPMI data led to the identification of five potential predictive factors for PD — smell loss, age, gender, family history of PD and a genetic risk score.
Hot Topics in Parkinson’s Disease Research
Novel ways to deliver levodopa and innovative methods of tracking symptoms and disease progression rounded out the day. C. Warren Olanow, MD, Mount Sinai, brought us up to speed on dyskinesias(abnormal involuntary movements) and how continuous levodopa delivery might prevent them. He discussed Rytary and Duopa — the latest levodopa preparations to reach market in early 2015 — and then delved into formulations in development — the Accordion pill (designed to slowly release levodopa from the stomach) and continuous under the skin and oral administrations. The first two are in Phase III studies; the oral therapy is in Phase II trials.
12 November 2015 – Sydney, Australia & Auckland, New Zealand –
Living Cell Technologies Limited’s application to conduct a Phase IIb study of NTCELL® in Parkinson’s disease has been authorised, subject to the usual conditions, by New Zealand’s Minister of Health, Hon Dr Jonathan Coleman
The study protocol will now be submitted to the ethics committee for approval. Once the committee has approved the study design, patient recruitment can commence.
The study will involve up to 18 patients under the age of 65 who have had Parkinson’s disease for at least 5 years. Patients will be treated in three groups. Each group will receive bilateral implants of NTCELL at a range of doses. In each group, two patients will receive a placebo dose.
At the end of the 26-week follow up period the study will be unblinded, at which point the patients who received the placebo will receive an implant of NTCELL at the dose determined to be most effective.
LCT intends to begin patient recruitment in December 2015. LCT expects the first patient to be implanted in February 2016 and the study will be completed in 2017.
CEO of Living Cell Technologies, Dr Ken Taylor, says the study is the next step in the company’s development of NTCELL as a disease-altering treatment for Parkinson’s disease.
“We’re looking to confirm the ability of NTCELL to halt disease progression and restore quality of life for people with Parkinson’s disease,” says Dr Taylor.
The minister also authorised an amendment to the protocol of the Phase I/IIa study to enable ongoing monitoring of the four patients in that study. Evaluation of the patients at 42 weeks post-implant showed a clinically and statistically significant improvement in their neurological scores from their pre-implant baseline. That improvement is equivalent to approximately 5 years of Parkinson’s disease remission.
NEURODERM ANNOUNCES STREAMLINED U.S. DEVELOPMENT PLAN FOLLOWING FDA FEEDBACK ON ND0612H AND ND0612L FOR THE TREATMENT OF PARKINSON'S DISEASE
Company to host conference call today at 8:30 a.m. ET
/EIN News/ -- REHOVOT, Israel, Nov. 11, 2015 (GLOBE NEWSWIRE) -- NeuroDerm Ltd. (Nasdaq:NDRM), a clinical-stage pharmaceutical company developing drugs for central nervous system (CNS) diseases, today announced that it has modified its U.S. development plan for ND0612H and ND0612L, the company's continuous, subcutaneously delivered levodopa/carbidopa product candidates for the treatment of Parkinson's disease. The updated and abbreviated plan incorporates written feedback that the company recently received from the U.S. Food and Drug Administration (FDA) within the framework of an ongoing Type C meeting communication that was initiated by the company. NeuroDerm asked the agency to provide strategic and operational guidance related to the U.S. clinical and regulatory development of ND0612H and ND0612L.
NeuroDerm's new development plan for ND0612H and ND0612L consists of the following:
Clinical development of ND0612H for the U.S. will proceed as planned with one Phase II trial and one Phase III trial of essentially the same design, treatment duration and patient numbers as originally planned. The Phase II trial will include centers in Israel and the EU in addition to U.S. centers, however essentially preserving the original design, number of centers, number of patients and treatment duration.
Clinical development of ND0612L for the U.S. and the EU will be based on only one and not two pivotal efficacy trials of essentially the same design, treatment duration and patient numbers (200-240) as originally planned. The second pivotal efficacy trial of 360 patients that was originally planned for this product candidate is not required by the FDA.
ND0612 Safety Follow-up:
A safety follow up study for both ND0612H and ND0612L will include at least 100 patients treated for one year of whom at least half will receive the maximum dose. The safety follow-up studies that were originally planned included 50-150 patients treated for 6-12 months for each of the product candidates.
The supplier of the delivery devices used in the clinical trials of both ND0612L and ND0612H has been requested by the FDA to provide additional documentation pertaining to good manufacturing practices of the Quality System regulation. Until documentation is provided to the satisfaction of the FDA, this supplier may not import devices into the U.S. This does not preclude the sale or use of devices currently in the U.S. nor the importation of devices for investigational purposes if approved as part of an investigational study. Nevertheless, NeuroDerm has decided to request additional documentation from the device manufacturer before proceeding with enrollment at U.S. investigator sites. Patient enrollment in its upcoming clinical trials will thus begin at non-U.S. investigator sites. NeuroDerm expects that the requested documents will be provided by the supplier in the first quarter of 2016 enabling the company to start enrolling U.S. patients in the second quarter of 2016.
In the EU, the pharmacokinetic pilot dose finding study of ND0612H is ongoing and topline results are now expected in the second quarter of 2016. NeuroDerm does not foresee any changes to previously disclosed timelines related to anticipated EU submission.
The currently anticipated timelines for the ongoing and upcoming clinical trials are as follows:
- Pharmacokinetic (PK) pilot dose finding study (EU trial): ongoing; topline results expected in the second quarter of 2016
- Initiation of Phase II efficacy trial and long-term safety follow-up (Israel-EU-U.S.): end of 2015 – beginning of 2016
"We are pleased that based on feedback from the FDA the largest clinical trial in our development program will not be required, resulting in a streamlined clinical development plan," said Oded S. Lieberman, PhD, NeuroDerm's CEO. "We believe our product candidates have the potential to revolutionize the treatment of Parkinson's disease and we are committed to provide a new treatment option to both advanced and moderate Parkinson's patients."
Conference Call Details
NeuroDerm will host a conference call at 8:30 a.m. ET today to discuss the Company's updated development strategy and review third quarter 2015 financial results. Individuals can access the webcast in the Events and Presentations section of the Company's website, by clicking here, or by dialing 888-389-5988 (U.S.) or 719-325-2428 (outside of the U.S.). The passcode is 5664132. A webcast will be archived on the website.
ND0612H and ND0612L
ND0612H and ND0612L are designed to significantly reduce motor complications in Parkinson's disease patients through continuous, subcutaneous delivery of LD/CD. Previously completed Phase II trials demonstrated that ND0612L maintained steady, therapeutic levodopa plasma concentrations that were associated with major changes in several clinical parameters including "off time" reductions when added to optimized oral standard of care. ND0612H, intended for severe Parkinson's disease patients, was shown to reach even higher levodopa steady plasma levels, indicating that it may provide an effective therapy alternative to current treatments requiring surgery such as deep brain stimulation and LD/CD Intestinal Gel.
About Parkinson's disease
Parkinson's disease is a progressive neurodegenerative illness characterized by reduced dopamine in the brain, resulting in a debilitating decrease in the patient's motor and non-motor functions. Its symptoms, such as trembling in the extremities and face, slowness of movement and impaired balance and coordination, worsen over time and gravely impact the patient's quality of life. As the disease progresses, these symptoms become more severe, resulting in debilitating periods of decreased motor and non-motor functions, also referred to as "off" time. In addition, mainly as a result of excessive/intermittent oral doses of levodopa aimed at treating the "off" time, some patients experience involuntary movements, or dyskinesia. The "off" time and dyskinesia affect the majority of Parkinson's disease patients and interfere with day-to-day functions, causing patients to become severely disabled. Continuous administration of levodopa has been shown to effectively treat motor fluctuations in Parkinson's disease patients, however, a convenient route of continuous administration has not been introduced to date.
NeuroDerm is a clinical-stage pharmaceutical company developing central nervous system (CNS) product candidates that are designed to overcome major deficiencies of current treatments and achieve enhanced clinical efficacy through continuous, controlled administration. In Parkinson's disease, the company has four product candidates in different stages of development which offer a solution for almost every Parkinson's disease patient from the moderate to the very severe stage of the disease. The company has developed a line of LD/CD product candidates administered through small belt pumps that deliver a continuous, controlled dose of LD/CD. The LD/CD line of product candidates includes: ND0612L and ND0612H, delivered subcutaneously, for moderate and for advanced Parkinson's disease patients, respectively. In addition, NeuroDerm is developing ND0701, a novel subcutaneously delivered apomorphine formulation for patients who suffer from severe Parkinson's disease and who do not respond well to LD/CD. NeuroDerm is headquartered in the Weizmann Science Park in Rehovot, Israel.
- Initiation of Phase III efficacy trial and long-term safety follow-up (Israel-EU-U.S.): first half of 2016
CONTACT: NeuroDerm Contact:
Oded S. Lieberman, PhD, MBA, CEO
Cell: +1-617-517 6
Tel.: +972-8-946 27077
U.S. Investor and Media Contact:
Lazar Partners Ltd. rs.com
CONTACT: NeuroDerm Contact:
Oded S. Lieberman, PhD, MBA, CEO
Cell: +1-617-517 6
Tel.: +972-8-946 27077
U.S. Investor and Media Contact:
Lazar Partners Ltd. rs.com