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Potential disease-modifying therapies are entering trials for Parkinson’s disease even as researchers need better biomarkers to track clinical improvement. Some believe that smartphones might hold the key. At the 13th International Conference on Alzheimer’s and Parkinson’s Diseases, held March 29 to April 2 in Vienna, scientists from Roche and Prothena discussed how they are using these devices to collect detailed clinical data from trial participants. The two companies collaborate on trials of Prothena’s anti-α-synuclein antibody PRX002 (see related conference story). In Vienna, Michael Lindemann of Roche Research & Early Development presented Phase 1 data from smartphones that suggested they more sensitively and accurately reflect small clinical changes than do traditional measures. Crucially, smartphone data closely correlated with the validated clinical measure for PD, the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS).
“This study shows you can use sensor data to correctly represent clinical severity,” Lindemann said. He believes these data are sensitive enough to track both disease progression and treatment effects. Potentially, the data could distinguish people who progress quickly from those whose disease advances slowly. Such information would help researchers stratify trials and better gauge whether treatments are working, Lindemann noted.
Currently, most PD trials rely on the MDS-UPDRS as the primary outcome measure. However, because the UPDRS is only assessed in the clinic, this scale cannot capture the day-to-day fluctuations in function that torment people with PD, and scientists have been searching for alternatives. Some groups are touting the benefits of technology such as smartphones to collect continuous data on neurodegenerative disease and paint a fuller picture of daily variability than an occasional clinic visit allows (see Dec 2012 news). This idea is starting to take hold in Parkinson’s disease, perhaps because, being a movement disorder, it is particularly amenable to the type of data easily collected by smartphone. Various projects have already begun to gather observational data from PD cohorts in this way (Mar 2016 news; PD Smartphone Data Challenge).
In Vienna, Lindemann described how the PRX002 Phase 1b trial used smartphones to monitor symptoms. These devices contain a gyroscope and accelerometer that enable them to detect movement of various types. Participants in the three highest dose cohorts were offered phones that they carried with them throughout the trial. This was optional, but all 44 participants in these cohorts decided to do it, Lindemann noted. The phones collected data for the full 24 weeks of the study. In addition to passive monitoring of gait and movement by phone, participants were asked to complete six specific tasks every day that measured their balance, walking, dexterity, postural tremor, resting tremor, and steadiness of voice.
Participants performed these tasks quite faithfully, Lindemann noted. At the beginning of the trial, the cohort as a whole collected 75 percent of the requested data points, and by the end of the six months, completed 50 percent of the requested tests. Notably, 90 percent of the participants performed the tasks at least once every four days, providing regular data points for analysis. This level of adherence is much higher than that seen in observational studies. Lindemann ascribes this partly to the personal relationship participants developed with the study center staff, and to the degree they trusted that their data would be used well and contribute to advancing PD treatments. He added that the research team also worked hard to make the apps easy to use and the daily tasks not unduly burdensome.
Others agree. Lara Mangravite of Sage Bionetworks, Seattle, ran a previous observational study. She said that trial participants typically feel a strong sense of commitment to provide as much data as possible to support development of new therapeutic agents for their disease. “Patients who provide mobile data collection within the context of a clinical trial consistently demonstrate greater adherence than those using mobile data collection as part of observational trials that are performed remotely,” she wrote to Alzforum.
Importantly, data collected from the smartphones correlated well with MDS-UPDRS scores, Lindemann said. However, smartphone data did not always match up with UPDRS categories of the same name. Balance detected by smartphone, for example, did not correlate that well with the “postural instability” category of the UPDRS, which is measured by the physician tugging patients backward and seeing how well they can regain their footing. Instead, the smartphone balance measure matched up almost perfectly with the “posture” category of the UPDRS, which assesses static balance. The smartphone dexterity test, which involves tapping spots on the screen, correlated with “dressing” in the UPDRS scale, because this task involves fine motor coordination as people manage buttons and zippers.
While scores from the UPDRS and smartphone tests matched, the latter included additional details that filled in the clinical picture, Lindemann said. Patients who scored a zero on the MDS-UPDRS scale for resting tremor, meaning the clinician did not see a tremor, in fact did have a tremor that their smartphone picked up. When patients self-assessed their own tremors, the results better matched their smartphone data than their UPDRS score, indicating that the phone more faithfully reflected the patient’s experience than did the clinician. Lindemann noted that in these cases, the patient’s tremor might not be present during the 15-minute office visit, but might come out at other times.
Moreover, smartphones were more sensitive at detecting small changes, Lindemann said. For example, one patient who started on a standard symptomatic therapy a month before the end of the trial showed distinct motor improvement on the high-frequency smartphone monitoring data, but the pattern was quite noisy. The effects were also subtle, amounting to about a 10 percent improvement in the dexterity measure. Sampling data from just two timepoints, as baseline and follow-up clinic visits would have done, likely would have missed this narrow improvement, Lindemann said
The data indicate that smartphone technology is feasible to use in a trial, and can detect subtle and clinically meaningful motor impairments, Lindemann concluded. “Remote patient monitoring will transform clinical research,” he predicted, adding that smartphone monitoring will be included in the Phase 2 PRX002 trial.—Madolyn Bowman Rogers
Men with higher occupational exposure to extremely low frequency (ELF) magnetic fields had an elevated risk for dementia and trends toward elevated risks for motor neuron disease, multiple sclerosis (MS), and epilepsy.
Why this matters
Previous studies of ELF exposure and neurologic disease have had fairly short follow-up.
Compared with men in the general population who had never worked at the utilities, men with medium ELF exposure (0.1-0.99 µT) had a trend toward an elevated risk for motor neuron disease (incidence rate ratio, 1.24) and a significantly reduced risk of Parkinson's disease (0.81).
Men with high ELF exposure (≥1.0 µT) had a significantly elevated risk for dementia (incidence rate ratio, 1.44) and trends toward elevated risks for motor neuron disease (1.78), MS (1.40), and epilepsy (1.34).
Findings were mixed when the comparator was instead men within the cohort having a lower level of exposure.
A cohort study of 32,006 male employees of 99 Danish electrical utility companies.
Main outcomes were risks for neurologic disorders during a mean follow-up of 20.8 y.
Funding: Danish Energy; Danish Cancer Society.
The registry identified only cases with hospital contact.
Pedersen C, Poulsen AH, Rod NH, Frei P, Hansen J, Grell K, Raaschou-Nielsen O, Schüz J, Johansen C. Occupational exposure to extremely low-frequency magnetic fields and risk for central nervous system disease: an update of a Danish cohort study among utility workers. Int Arch Occup Environ Health. 2017 Apr 20 [Epub ahead of print]. doi: 10.1007/s00420-017-1224-0. PMID: 28429106
Evidence of whether exposure to extremely low-frequency magnetic fields (ELF-MF) is related to central nervous system diseases is inconsistent. This study updates a previous study of the incidence of such diseases in a large cohort of Danish utility workers by almost doubling the period of follow-up.
We investigated the risks for dementia, motor neurone disease, Parkinson disease, multiple sclerosis and epilepsy among 32,006 men employed at the 99 utility companies that supplied Denmark with electricity during the period 1900-1993. Cases were identified in the Danish National Patient Registry and the cohort was followed during 1982-2010. Exposure was estimated from a job-exposure matrix based on company records of job title and area of work and cohort members were allocated to one of three categories (<0.1, 0.1-0.99 and ≥1.0 µT).
For dementia, multiple sclerosis and epilepsy the incidence rate ratios (IRR) were close to unity, but higher for motor neurone disease [IRR 1.24, 95% confidence interval (CI) 0.86-1.79] and lower for Parkinson disease (IRR 0.81, 95% CI 0.67-0.97) among workers exposed to ≥0.1 µT compared with the Danish population. For the highest level of exposure (≥1.0 µT), IRRs of 1.44, 1.78, 1.40 and 1.34 were observed for dementia, motor neurone disease, multiple sclerosis and epilepsy, respectively.
We observed elevated risks of dementia, motor neurone disease, multiple sclerosis and epilepsy and lower risks of Parkinson disease in relation to exposure to ELF-MF in a large cohort of utility employees.
Central nervous system disease; Cohort study; ELF-MF; Occupational exposure
Malek N, Lawton MA, Grosset KA, Bajaj N, Barker RA, Ben-Shlomo Y, Burn DJ, Foltynie T, Hardy J, Morris HR, Williams NM, Wood N, Grosset DG. Utility of the new Movement Disorder Society clinical diagnostic criteria for Parkinson's disease applied retrospectively in a large cohort study of recent onset cases. Parkinsonism Relat Disord. 2017 Apr 12 [Epub ahead of print]. doi: 10.1016/j.parkreldis.2017.04.006. PMID: 28431829
To examine the utility of the new Movement Disorder Society (MDS) diagnostic criteria in a large cohort of Parkinson's disease (PD) patients.
Recently diagnosed (<3.5 years) PD cases fulfilling United Kingdom (UK) brain bank criteria in Tracking Parkinson's, a UK multicenter prospective natural history study were assessed by retrospective application of the MDS criteria.
In 2000 cases, 1835 (91.7%) met MDS criteria for PD, either clinically established (n = 1261, 63.1%) or clinically probable (n = 574, 28.7%), leaving 165 (8.3%) not fulfilling criteria. Clinically established cases were significantly more likely to have limb rest tremor (89.3%), a good l-dopa response (79.5%), and olfactory loss (71.1%), than clinically probable cases (60.6%, 44.4%, and 34.5% respectively), but differences between probable PD and 'not PD' cases were less evident. In cases not fulfilling criteria, the mean MDS UPDRS3 score (25.1, SD 13.2) was significantly higher than in probable PD (22.3, SD 12.7, p = 0.016) but not established PD (22.9, SD 12.0, p = 0.066). The l-dopa equivalent daily dose of 341 mg (SD 261) in non-PD cases was significantly higher than in probable PD (250 mg, SD 214, p < 0.001) and established PD (308 mg, SD 199, p = 0.025). After 30 months' follow-up, 89.5% of clinically established cases at baseline remained as PD (established/probable), and 86.9% of those categorized as clinically probable at baseline remained as PD (established/probable). Cases not fulfilling PD criteria had more severe parkinsonism, in particular relating to postural instability, gait problems, and cognitive impairment.
Over 90% of cases clinically diagnosed as early PD fulfilled the MDS criteria for PD. Those not fulfilling criteria may have an atypical parkinsonian disorder or secondary parkinsonism that is not correctly identified by the UK Brain Bank criteria, but possibly by the new criteria.
SUN CITY WEST, Ariz., and SCOTTSDALE, Ariz. – Researchers at Banner Sun Health Research Institute and Mayo Clinic are continuing to study how to diagnose early Parkinson’s disease. The research team’s most recent article, “Peripheral Synucleinopathy in Early Parkinson’s Disease: Submandibular Gland Needle Biopsy Findings,” has been recognized by Movement Disorders, the official journal of the International Parkinson and Movement Disorders Society, as the “best original research article” of 2016.
Parkinson's disease is a progressive disorder of the nervous system that affects movement, as well as sleep, balance, blood pressure and smell. It develops gradually, sometimes starting with a barely noticeable tremor in just one hand. While tremor may be the best-known sign of Parkinson's, the disorder also commonly causes stiffness or slowing of movement. Diagnosis is made based on medical history, a review of signs and symptoms, a neurological examination, and by ruling out other conditions. Up to 55 percent of patients may be misdiagnosed early in the disease.
Although Parkinson's disease can't be cured, medications may markedly improve symptoms. And, while there is no diagnostic test for Parkinson’s disease, the researchers believe that a procedure termed transcutaneous submandibular gland biopsy may provide the needed accuracy. The test involves inserting a needle into the submandibular gland under the jaw that creates saliva and then withdrawing the needle to obtain the core of the gland tissue within. From this test, researchers can compare the tissue extracted from patients with Parkinson’s disease to patients who do not have Parkinson’s disease.
“This was the first study demonstrating the value of testing a portion of the submandibular gland to diagnose a living person with early Parkinson's disease. Making a diagnosis in living patients is a big step forward in our effort to understand and better treat patients," says study author Charles Adler, M.D., Ph.D., a Mayo Clinic neurologist.
As part of the study, 25 Mayo Clinic patients with Parkinson's disease and 10 people without it had the procedure done. Biopsies were taken from one submandibular gland ─ completed as an office procedure by Michael Hinni, M.D., and David Lott, M.D. ─ both Mayo Clinic otorhinolaryngologists. Then, the biopsied tissues were tested for evidence of the abnormal Parkinson's protein by study co-author Thomas Beach, M.D., Ph.D., a neuropathologist with Banner Sun Health Research Institute. The abnormal Parkinson's protein was detected in 14 of the 19 patients who had enough tissue to study. This indicated the need for further analysis. The research team previously had shown that the biopsy was able to detect the protein in 9 of 12 patients with advanced disease.
"This [submandibular gland biopsy] procedure will very likely provide a much more accurate diagnosis of early Parkinson's disease than what is now available," says Dr. Beach. "One of the greatest potential impacts of this finding is on clinical trials, as, at the present time, some patients entered into Parkinson's clinical trials do not necessarily have Parkinson's disease. And this is a big impediment to testing new therapies."
"This study provides the first direct evidence for the use of submandibular gland biopsies as a diagnostic test for living patients with early Parkinson's disease," says Dr. Adler. "This finding in patients with early Parkinson’s disease may be of great use, since accuracy of diagnosis in patients with early disease is not nearly as good as in those having the disease for more than five years.”
The study is now finished but has been followed by a similar Michael J. Fox Foundation-funded study (the “S4” study), being performed in multiple U.S. and Canadian cities. This study will compare submandibular gland needle biopsy with biopsies of the colon and skin. Drs. Adler and Beach are heavily involved in study planning and analysis, while Drs. Lott and Hinni conducted online training sessions for the participating surgeons.
This study was funded by the Michael J. Fox Foundation for Parkinson's Research.
About Banner Sun Health Research InstituteSince 1986, Banner Sun Health Research Institute, part of nonprofit Banner Health, has been a leader nationally and internationally in the effort to find answers to disorders of aging, including Alzheimer’s and Parkinson’s disease. The institute, together with its Arizona Alzheimer’s Consortium partners, has been designated by the National Institutes of Health as one of just 29 Alzheimer’s Disease Centers in the nation. The institute’s Cleo Roberts Center for Clinical Research takes laboratory discoveries to clinical trials that foster hope for new treatments. Banner Health is Arizona’s leading health care provider and largest private employer. For more information, visit bannershri.org.
About The Michael J. Fox Foundation for Parkinson’s ResearchAs the world’s largest funder of Parkinson’s research, the Michael J. Fox Foundation is dedicated to accelerating a cure for Parkinson’s disease and improved therapies for those living with the condition today. The foundation pursues its goals through aggressively funded, highly targeted research programs, coupled with active global engagement of scientists, Parkinson’s patients, business leaders, clinical trial participants, donors and volunteers. In addition to funding more than $325 million in research to date, the foundation has fundamentally altered the trajectory of progress toward a cure. Operating at the hub of worldwide Parkinson’s research, the foundation forges groundbreaking collaborations with industry leaders, academic scientists and government research funders; increases the flow of participants into Parkinson’s disease clinical trials with its online tool, Fox Trial Finder; promotes Parkinson’s awareness through high-profile advocacy, events and outreach; and coordinates the grass-roots involvement of thousands of Team Fox members around the world.
The 60th Anniversary Gala to benefit Parkinson's Foundation will take place Wednesday, May 31, 2017 in the Garden Terrace Room at the New York Botanical Garden in the Bronx, NY. The Gala marks the60th Anniversary of both the Parkinson's Disease Foundation (PDF) and the National Parkinson Foundation (NPF), the legacy organizations of the Parkinson's Foundation and recognizes their strength in working toward a world without Parkinson's together.
The Page and William Black Humanitarian Award will be awarded to Robin Anthony Elliott, retiring CEO Emeritus of the PDF division of the Parkinson's Foundation. The James Parkinson Award will be awarded to Heiko Braak, M.D., of the Center for Biomedical Research, University of Ulm, Germany, for his enormous contribution in focusing the science of Parkinson's on the spread of alpha-synuclein as a major factor in the progression of the disease.
Willie Geist, Host of NBC News' "Sunday TODAY with Willie Geist" and Co-Host of MSNBC's "Morning Joe", is the Master of Ceremonies for the Gala. Margo and John Catsimatidis are the Gala Chairs. Andrew B. Albert, Karen Elizabeth Burke, M.D., Ph.D., Jill Taub Drury, G. Pennington Egbert III, Richard D. Field, Guido Goldman, Stephanie Goldman, Isobel Robins Konecky, John W. Kozyak, Esq., Arlene Levine, Howard D. Morgan, Robert Moss, Devon Pastor and Doug Stern are the Gala Co-Chairs. Musical entertainment will be provided by Joe D'Urso & Stone Caravan, Members of the Light of Day Foundation.
The evening will begin with a cocktail reception at 6:30 PM followed by dinner and the awards at 7:30 PM. Support levels are as follows: Tables at $100,000, $50,000, $25,000 and $12,500; Tickets at $1,250 or $350 (under age 40).
The Parkinson's Foundation is working toward a world without Parkinson's disease. Formed by the merger of National Parkinson Foundation (NPF) and the Parkinson's Disease Foundation (PDF) in August 2016, the mission of the Parkinson's Foundation is to invest in promising scientific research that will end Parkinson's disease and improve the lives of people with Parkinson's and their families, through improved treatments, support and the best care.
For more information on the Parkinson's Foundation and to purchase tickets, call (800) 457-6676 or visit www.pdf.org/gala.
Stem Cell Corporation (OTCQB:ISCO), a California-based clinical stage
biotechnology company developing stem cell-based therapies and biomedical
products, today announced that its Chief Scientific Officer, Russell Kern, PhD,
will deliver an oral presentation on the Company's Parkinson's disease clinical
trial at the American Society of Gene & Cell Therapy 20th Annual Meeting at
the Marriott Wardman Park in Washington, DC.
Session title: Pharmacology,
Toxicology and Assay Development
Pharmacology and Toxicology Studies Conducted for the First-in-Human Clinical
Study of Neural Stem Cells in Parkinson’s Disease
The Phase I
clinical study is a dose escalation safety and preliminary efficacy study of
ISC-hpNSC®, intracranially transplanted into patients with moderate to severe
Parkinson's disease. The open-label, single center, uncontrolled clinical trial
will evaluate three different dose regimens of 30,000,000 to 70,000,000 neural
cells. A total of 12 participants with moderate to severe Parkinson's disease
will be treated. Following transplantation, the patients will be monitored for
12 months at specified intervals, to evaluate the safety and biologic activity
of ISC-hpNSC®. PET scan will be performed at baseline, as part of the screening
assessment, and at 6 and 12 months after surgical intervention. Clinical
responses compared to baseline after the administration of ISC-hpNSC® will be
evaluated using various neurological assessments such as Unified Parkinson
Disease Rating Scale (UPDRS), Hoehn and Yahr and other rating scales.
disease (PD) is a degenerative disorder of the central nervous system mainly
affecting the motor system. The motor symptoms of Parkinson's disease result
from the death of dopamine-generating cells in the substantia nigra, a region
of the midbrain. Early in the course of the disease, the most obvious symptoms
are movement-related; these symptoms include shaking, rigidity, slowness of
movement and difficulty with walking and gait. Later, thinking and behavioral
problems may arise, with dementia commonly occurring in the advanced stages of
the disease, and depression is the most common psychiatric symptom. Parkinson's
disease is more common in older people, with most cases occurring after the age
medications typically used in the treatment of Parkinson's, L-DOPA and dopamine
agonists, improve the early symptoms of the disease. As the disease progresses
and dopaminergic neurons continue to be lost, the drugs eventually become
ineffective while at the same time frequently producing a complication marked
by involuntary writhing movements. In 2013 PD resulted in about 103,000 deaths
globally, up from 44,000 deaths in 1990.
Stem Cell Corporation's proprietary ISC-hpNSC® consists of a highly pure
population of neural stem cells derived from human parthenogenetic stem cells.
ISC-hpNSC® is a suspension of clinical grade cells manufactured under cGMP
conditions that have undergone stringent quality control measures and are clear
of any microbial and viral contaminants. Preclinical studies in rodents and
non-human primates have shown improvement in Parkinson's disease symptoms and
increase in brain dopamine levels following the intracranial administration of
ISC-hpNSC®. ISC-hpNSC® provides neurotrophic support and cell replacement to
the dying dopaminergic neurons of the recipient PD brain. Additionally,
ISC-hpNSC® is safe, well tolerated and does not cause adverse events such as
dyskinesia, systemic toxicity or tumors in preclinical models. International
Stem Cell Corporation believes that ISC-hpNSC® may have broad therapeutic
applications for many neurological diseases affecting the brain, the spinal
cord and the eye.
International Stem Cell Corporation
Stem Cell Corporation (ISCO) is focused on the therapeutic applications of
human parthenogenetic stem cells (hpSCs) and the development and
commercialization of cell-based research and cosmetic products. ISCO's core
technology, parthenogenesis, results in the creation of pluripotent human stem
cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated
with the use or destruction of viable human embryos. ISCO scientists have
created the first parthenogenetic, homozygous stem cell line that can be a
source of therapeutic cells for hundreds of millions of individuals of
differing genders, ages and racial background with minimal immune rejection
after transplantation. hpSCs offer the potential to create the first true stem
cell bank, UniStemCell™. ISCO also produces and markets specialized cells and
growth media for therapeutic research worldwide through its subsidiary Lifeline
Cell Technology (www.lifelinecelltech.com),
and stem cell-based skin care products through its subsidiary Lifeline Skin
More information is available at www.internationalstemcell.com.
pertaining to anticipated developments, expected results and timing of clinical
studies, potential applications of ISC-hpNSC® to other diseases, progress of
research and development initiatives, and other opportunities for the company
and its subsidiaries, along with other statements about the future
expectations, beliefs, goals, plans, or prospects expressed by management
constitute forward-looking statements. Any statements that are not historical
fact (including, but not limited to statements that contain words such as
"will," "believes," "plans,"
"anticipates," "expects," "estimates,") should
also be considered to be forward-looking statements. Forward-looking statements
involve risks and uncertainties, including, without limitation, risks inherent
in the development and/or commercialization of potential products (including
clinical trial results that differ from expectations based on earlier studies),
regulatory approvals, need and ability to obtain future capital, application of
capital resources among competing uses, and maintenance of intellectual
property rights. Actual results may differ materially from the results
anticipated in these forward-looking statements and as such should be evaluated
together with the many uncertainties that affect the company's business,
particularly those mentioned in the cautionary statements found in the
company's Securities and Exchange Commission filings. The company disclaims any
intent or obligation to update forward-looking statements.