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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.
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Friday, November 21, 2014
Cynapsus reports positive top-line results from CTH-105 phase II trial of APL-130277 to treat Parkinson's Disease
Cynapsus Therapeutics, a specialty pharmaceutical company focused on Parkinson’s disease, announced positive top-line results from its CTH-105 Phase II clinical trial of APL-130277 for the management of OFF motor symptoms of Parkinson’s disease.
APL-130277 is the Company's fast-acting, sublingual, thin filmstrip formulation of apomorphine. OFF episodes are a complication of Parkinson's disease that leave patients rigid and unable to move and communicate.
An estimated one quarter to one half of all people with Parkinson's disease whose symptoms are otherwise managed with ongoing drug therapy, experience OFF episodes at least once daily and up to six times daily, with each episode lasting between 30 and 120 minutes.
"The purpose of the CTH-105 study was to better understand the APL-130277 dose range that produced efficacy as measured by the change in the Unified Parkinson's Disease Rating Scale (UPDRS) part III, a scale used by neurologists to measure the severity of Parkinson's disease OFF and motor symptoms, compared with baseline. We are encouraged that APL-130277 provided clinical benefit at all five doses used in this study," said Dr. Albert Agro, Chief Medical Officer of Cynapsus.
"These preliminary data show that APL-130277 was able to convert patients from a severe OFF state in the morning to ON. In addition, treatment was associated with a 45% improvement in motor function based on the change in UPDRS part III from baseline. The mean dose needed to terminate the OFF episode was 18.4mg. In addition, those patients achieving a response at higher doses appeared to adapt to the treatment, as seen by the lack of nausea at higher doses."
In the CTH-105 multicenter open-label study, APL-130277 was assessed in 16 patients with Parkinson's disease who experience the debilitating effects of OFF episodes, with a total duration of OFF of at least two hours daily.
To date, 16 patients have completed the dosing regimen, which was the planned sample size for the study. Due to over enrollment, an additional three patients are still in dosing. OFF episodes were achieved by having patients take their last dose of levodopa the night before they came into the clinic.
Patients were not allowed to take their first dose of levodopa in the morning, resulting in a severe OFF state that is one of the most difficult to convert and maintain in an ON state.
Patients were then given escalating doses of APL-130277 (at a minimum of three hours between doses) until ON was achieved, as documented by study staff, the patient, and a clinician assessment of UPDRS part III. The UPDRS III part score was measured at 15, 30, 45, 60 and 90 minutes.
All five doses of APL-130277 used in the study (10, 15, 20, 25 and 30mg) resulted in patients moving from OFF to ON. The mean baseline UPDRS part III in an OFF state was 41.4, and the maximum mean change from baseline UPDRS part III was 18.4.
The mean dose required to convert patients to ON was 18.4mg. The onset of a clinically meaningful improvement was seen in as early as 10 minutes and lasted up to 90 minutes, the last time point measured in this study.
The mean time to ON as reported by study staff was 22 minutes. Cynapsus believes that these data strongly support the conclusion that APL-130277 is associated with the robust and rapid management of OFF episodes.
The graph below (click the multimedia link) shows the mean change from baseline in UPDRS part III for the 14 subjects who converted to ON. Two patients dosed at the highest available dose (30mg) did not achieve a full ON as assessed by the investigator, suggesting that higher doses may be required for some patients.
Treatment with APL-130277 was safe and well tolerated. Nausea was reported by three subjects at doses of 10, 15 and 20mg. One of these patients also experienced a mild episode of emesis. There were no reports of nausea at higher doses. There were no reports of local irritation or hypotension in any subject treated. A total of 60 doses of APL-130277 were administered to the 16 patients who completed dosing in the CTH-105 study.
Based on the findings of this study, Cynapsus is planning to conduct pivotal studies of longer duration and with larger patient numbers to confirm these results. These pivotal studies are expected to form the registration package necessary for a 505(b)(2) New Drug Application with the U.S. Food and Drug Administration expected to be submitted in 2016.
"The results of this Phase 2 trial are important as the data show that APL-130277 provided Parkinson's patients with a rapid improvement in motor function during OFF episodes," said Anthony Giovinazzo, President and CEO of Cynapsus.
"APL-130277 is being developed to address a significant unmet need facing people with Parkinson's disease today. The CTH-105 trial results lead us to maintain that APL-130277 may be able to serve the majority of Parkinson's patients seeking to restore movement rapidly, on demand, with an easy to retrieve and to administer form of apomorphine, the only approved and most efficacious drug for this purpose."
"OFF episodes are debilitating events for people with Parkinson's disease. A recent survey by The Michael J. Fox Foundation of 3,000 Parkinson's patients revealed that nearly half said their OFF time was moderate or severe, causing them to avoid or stop activities," said Dr. Todd Sherer, CEO of The Michael J. Fox Foundation for Parkinson's Research, which provided $500,000 in funding for this study.
"A rapid and reliable therapy that can address OFF episodes would be a major advancement in treatment. These results suggest that APL-130277 could provide patients with improved quality of life, and as supporters of this program from its early days, we look forward to continued success in Phase 3 trials."
People who are active are less likely to develop Parkinson's disease, according to a new study.
After following 43,368 people in Sweden for an average of 12.6 years, researchers found that even "a medium amount" of physical activity significantly lowers the risk of the neurodegenerative disorder.
The latest involved data from 27,863 females and 15,505 males participating in the Swedish National March Cohort. None of the participants had Parkinson's disease at the start of the study. Participants were followed from Oct. 2007 to Dec. 2010.
Researchers identified 286 participants who developed Parkinson's disease.
Further analysis revealed that people who spent more than six hours a week on household and community activity were 43 percent less likely to develop Parkinson's disease compared to those who spent less than two hours per week on the same types of activities. The study also revealed that men with "a medium level" of total physical activity were 45 percent less likely to develop Parkinson's disease. The study defined moderate physical activity as performing an average of 39.1 metabolic equivalent hours per day. Metabolic equivalent is determined by quantifying the estimated oxygen consumption associated with physical activity.
"Our study has a number of strengths. This was a prospective study including both males and females, and all information on physical activity was assessed before the disease occurrence, making recall bias and reverse causation less likely," study author Karin Wirdefeldt, researcher at the Department of Medical Epidemiology and Biostatistics and Department of Clinical Neuroscience, said in a news release.
"Another major strength of this study is that we considered the entire spectrum of daily energy output, rather than purely focusing on dedicated exercising. Further, we conducted a rich set of sensitivity analyses to test the robustness of our findings," she noted.
"We found that a medium level of daily total physical activity is associated with a lower risk of Parkinson's disease. The protective effect of physical activity was further supported when we summarized all available evidence from published prospective cohort studies. These findings are important for both the general population and for the healthcare of patients with Parkinson's disease," Wirdefeldt concluded.
The latest study was published online in Brain: A Journal of Neurology.
Thursday, November 20, 2014
November 20, 2014
A review of the scientific literature on Parkinson's disease, conducted by SISSA research scientists, shows that even the non-motor symptoms associated with the disease can contribute to the changes in body weight seen in patients (including those subjected to deep brain stimulation). Among the factors affecting eating habits and body weight there could be, for example, an impaired ability to derive pleasure from food and changes in motivation. These are important findings which can help to understand how to reduce these effects of Parkinson's that exacerbate an already negative clinical situation
Patients affected by Parkinson's disease often show marked changes in body weight: they may gain or lose a lot of weight depending on the stage of the disease, or they may put on up to ten kilos after deep brain stimulation (a treatment to alleviate the symptoms). This situation considerably worsens the quality of life of a person who is already suffering from heavily disabling motor disorders, so it is important to understand what are the factors that cause it.
"The body weight and eating habits of Parkinson's patients change as the disease progresses," explains Marilena Aiello, SISSA researcher and first author of the study published in the journal Appetite. "In our paper, we reviewed studies on Parkinson's that provided data on the association between non-motor symptoms and dietary habits and body weight. This way, we were able to evaluate some factors which, beyond the motor symptoms and drug treatments, might play a role in this problem."
Depression, cognitive impairment, sensory disturbances -- chiefly smell and taste -, impaired ability to feel pleasure: all these aspects contribute to incorrect eating habits. "The possible role of the ability to feel pleasure and motivation towards food consumption is particularly interesting. Parkinson's patients may be somewhat lacking in this respect and therefore eat less and lose weight, whereas the weight gain exhibited after deep brain stimulation seems to point to an increase in pleasure and motivation associated with food. Specific studies are required to confirm or refute this finding emerging from the literature review."
"Studies like ours can help those working with these patients: awareness of the roles played by the different factors is in fact crucial for devising interventions aiming to minimise the effect of the deficits and restore normal weight levels in individuals who are already suffering because of the disease."
The above story is based on materials provided by Sissa Medialab. Note: Materials may be edited for content and length.
1 Marilena Aiello, Roberto Eleopra, Raffella I. Rumiati. Body weight and food intake in Parkinson's disease. A review of the association to non-motor symptoms. Appetite, 2015; 84: 204 DOI: 10.1016/j.appet.2014.10.011
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Sissa Medialab. "Weight, eating habits in Parkinson's disease." ScienceDaily. ScienceDaily, 20 November 2014. <www.sciencedaily.com/releases/2014/11/141120082138.htm>.
Wednesday, November 19, 2014
November 19, 2014 - 12:31am
A new study, published online in Brain: A Journal of today, followed 43,368
individuals in Sweden for an average of 12.6 years to examine the impact of physical
activity on risk. It was found that "a medium amount" of physical
activity lowers the risk of Parkinson's disease.
Karin Wirdefeldt of the Karolinska Institutet in Stockholm and her colleagues used
National March Cohort to analyse comprehensive information on physical
activity of all kinds. They assessed household and commuting activity, occupational
activity, leisure time exercise, and total daily physical activity according to data
provided by 27,863 females and 15,505 males as part of an extensive .
For the purpose of this study, physical activity was quantified into metabolic equivalent
(MET) hours per day, based on estimated oxygen consumption associated with those
All participants were free of Parkinson's disease on 1 October 1997, the start of the
follow-up period. Study participants were followed from this baseline until date of
diagnosis with Parkinson's disease, date of death, date of emigration, or the end of
the follow-up period on 31 December 2010, whichever came first. In that time 286
cases of Parkinson's disease were identified.
In the study's multivariable-adjusted model, compared with participants who spent
less than two hours per week on household and commuting activity, those who spent
more than six hours per week on the same types of activities had a 43% lower risk of
developing Parkinson's disease. Compared with a low level of total physical activity, a
medium level of total physical activity (a mean of 39.1 MET hours per day) was
associated with a 45% lower Parkinson's disease risk in males. Leisure time exercise
was not associated with Parkinson's disease risk when analysed alone.
Karin Wirdefeldt, researcher at the Department Epidemiology and
Biostatistics and Department of Clinical Neuroscience, who headed the study, said:
"Our study has a number of strengths. This was a prospective study including both
males and females, and all information on physical activity was assessed before the
disease occurrence, making recall bias and reverse causation less likely."
"Another major strength of this study is that we considered the entire spectrum of daily
energy output, rather than purely focusing on dedicated exercising. Further, we
conducted a rich set of sensitivity analyses to test the robustness of our findings."
"We found that a medium level of daily total physical activity is associated with a lower
risk of Parkinson's disease. The protective effect of physical activity was further
supported when we summarized all available evidence from published prospective
cohort studies. These findings are important for both the general population and for
the healthcare of patients with Parkinson's disease."
Source: Oxford University Press