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Saturday, September 20, 2014

POLLS SHOW HIGHER STRESS IN CARING FOR SPOUSE



So you’ve promised “in sickness and in health,” but whose health? One new poll shows
that being the caregiver to an ill spouse carries more stress than caring for a mom, dad
or even your in-laws.

Although Americans 40 and older state that they are concerned about chronic illness
and losing their independence they believe 1) they can count on their families to care for
them and 2) that the costs will be covered by Medicare even though, as the poll found,
that half of these Americans have been caregivers to relatives or friends.
Amazingly, especially to those of us who have already cared for chronically ill family and
“preach” the importance of arranging for long-term care insurance while one is eligible,
find that neither the graying population nor the loved ones who expect to help them are
doing much planning for long-term care. Only 41 percent of this population has taken
the important first step of even discussing their preferences for long-term care with their
families and only 35 percent have set aside money to pay for their long-term care needs.

The well-known misperceptions surrounding the costs of long-term care services are
that a major portion of the population underestimate the costs of nursing home and/or
at-home care and overestimate the role of Medicare in paying for that care.
If you are, or become ill, how do you plan on being cared for? By whom, where, who will
cover the costs, etc.? Will this be the person who promised “In sickness or in health?”
Does one truly understand the meaning of the words “In sickness and in health, for
richer or for poorer, for better or for worse,” saying them when you’re high on love, you’re
generally healthy, and the dream of your fabulous life together is in front of you? The
meanings of these words are pretty much lost, even when you ponder them.
In a spousal/partnership situation, the relationship changes when one of them gets
chronically ill. Even when the possibilities of how care will be handled has been
discussed. Essentially the well spouse/partner leaves the role of intimate husband, wife
and/or partner and takes on the role of carer in a more medical or nurse-like sense.
Often, the addition of this new role carries with it stress, frustration, loneliness and,
at times, anger. That’s not to say that caregiving cannot or doesn’t strengthen the
marriage/partnership commitment.

Typically caregiving starts with driving a loved one to the doctor or helping with
household or other chores that were once handled by the ill spouse. From there the
care progresses to hands-on care, such as bathing, dressing, feeding, toileting, timing
and dispensing medications, helping with ambulating and more. Increasingly the well
spouse/partner is handling tasks that were once left to nurses.
More and more families are facing the responsibilities of caregiving. And not
addressed in too many poles and or articles, in the Parkinson’s world this is no longer
relegated to the greying or older generations: Government figures show nearly 7 in 10
Americans will need long-term care at some point after they reach age 65. Amazingly,
only 20 percent (1.5 to 2 out of 10) of those surveyed think it is likely they will need
such care someday. And yet, on the other hand, 39 percent are profoundly concerned
about burdening their families.
Only 30 percent of people polled say they believe they will likely care for a loved
one in the next five years and feel prepared to do so.
It has been documented that women tend to live longer than men and are
subsequently the greatest majority of family caregivers; the poll found that 41 percent have assisted a mother, 17 percent have cared for a father, and 14 percent have cared for a spouse or partner.

Of note is the stress on the sandwich generation—middle-aged people caring for both children and older parents, often while holding down a job—It has been well-documented, and the new poll found half of all caregivers report the experience caused stress in the family.
But spouses were most likely to report that stress and have stated that caregiving damaged their relationship with their partner and deeply reduced their finances.
While the hope is that family members will take on some of the caregiving tasks, spouses are more likely to handle most of the complex care tasks, and are on duty 24-7 with far less help from family and friends than they had hoped for.
Taking on the complex caregiving tasks is physically harder when considering that most
spouse caregivers tend to be older. The average age of spouse caregivers polled was 67, compared with people who’ve cared for a parent at an average age of 58.
One 79 year-old woman who cared for her husband for nearly five years while he suffered dementia and Parkinson’s syndrome, care that eventually required feeding, dressing and diapering him said,“I think I loved him more after I started caring for him. I saw what a wonderful person he was: his (positive) attitude, his kindness, his acceptance of things.” But he lived his last 11 months in a nursing home because “I couldn’t handle him anymore. He
was too big for me. He was as helpless as a baby.”

To help cope with Caregiver Stress consider the
following:

Attend Caregiver Support group meetings;
Keep a positive attitude. Believe in yourself;
Accept that there are events you cannot control;
Learn to relax;
Exercise regularly. Your body can fight stress better
when it is fit;
Limit yourself to moderate alcohol and caffeine
intake;
Set realistic goals and expectations;
Get enough rest and sleep;
Learn to use stress management techniques and
coping mechanisms, such as deep breathing or
guided imagery;

♥ If necessary consult a mental therapist.




MusicMendsMinds, Inc. is a new intergenerational senior and student music therapy project in the Los Angeles area that helps improve the health of seniors or People with Parkinson’s (PWPs) and/or Cognitive Dementia while reducing stress on families. The major side effect is creating happy memories across all generations.
Carol and Irwin Rosenstein recently founded this organization after their own success story with music and social support. Irwin, who practiced real estate law was diagnosed with Parkinson’s disease in 2006 (8 years ago). Until recently, the Rosenstein’s felt their lives slipping away while dealing with the adversities Parkinson’s can cause. Hope and life came back into their home and lives after Irwin’s passion for music was reignited by participating in a program called TimeOut @ UCLA, an intergenerational respite care program that connected students and seniors. Irwin’s memory, energy, and outlook on life improved dramatically, not only from playing the piano, but from mentoring the students—his new purpose in life.

Intergenerational support has been widely researched in social gerontology to help prevent isolation and stimulate cognitive functioning, keeping seniors integrated and engaged in the society and social life. Mrs. Rosenstein noticed Irwin’s over-the-top change and consulted with the neurologist who explained that “music may help stimulate increases in dopamine secretion from the brain for more sustained levels of energy and happiness”.

According to the American Psychological Association, music is a powerful medicine because it has multiple facets of healing through mind and body. Music can help alleviate the perception of pain and stress because it is associated with relaxation and may lower cortisol hormone levels.

Most importantly, the APA explains that music may ease the symptoms of Parkinson’s because it has the potential to improve movement coordination through the healing power of vibroacoustics (the process of hearing sound vibrations through the body). For these reasons, the Rosenstein’s wished to combine the powers of intergenerational support and music therapy to create an organization, MusicMendsMinds, Inc., which fosters the development of bands of musical seniors and students to help forestall the progression of such diseases like Parkinson’s, Alzheimer’s, and related dementias. UCLA sparked the idea of using music to improve the wellbeing of seniors and has offered to become involved in tracking improvements in cognitive function and physical abilities to support future research for music therapy programs.

MusicMendsMinds, Inc. has already created its first band, The 5th Dementia, and rehearsals are taking place at Windward School and the Brentwood Presbyterian Church.


If you, or someone you know, are a musical senior with early cognitive decline and/or Parkinson’s and interested in joining the band or participating in the Organization, visit MusicMendsMinds.org

Walking works more magic – this time in Parkinson’s

Parkinson's patient and activist John Krumbholz of Cedar Rapids, Iowa takes a walk. A new study shows walking can reduce the symptoms of Parkinson's disease.


Walking is an almost magic elixir, doctors like to say. It can reverse diabetes, lower blood pressure, and help people keep the fat off. Now a study shows it can also help people with Parkinson’s disease.
Parkinson’s patients who walked just three times a week felt less tired, less depressed and they found their Parkinson’s symptoms improved, also.
“The results of our study suggest that walking may provide a safe and easily accessible way of improving the symptoms of Parkinson’s disease and improve quality of life,” Dr. Ergun Uc of the University of Iowa and the Veterans Affairs Medical Center of Iowa City, who led the study.
The findings would only apply to Parkinson’s patients who can still walk easily. Parkinson’s is caused by the loss of brain cells that produce a message carrying-chemical, or neurotransmitter, that is important for movement. Symptoms can start with a barely noticeable trembling but worsen to difficulty walking and talking, depression and other disability. There’s no cure and the drugs used to treat the condition usually stop helping over time.
Some people have trouble walking. But for those who don’t, the study found, walking can help their symptoms.
And other research suggests that regular exercise can help slow down the progression of Parkinson’s. Various programs show that dancing,cycling, Pilates and even boxing can help.
But walking has a big advantage – people can do it anywhere, without special equipment, and on their own schedules.
For the study, Uc’s team recruited willing Parkinson’s patients and ran a battery of tests to make sure they were walking at a moderate pace, fast enough to raise their heart rates a bit, but not too much. The volunteers walked for 45 minutes at an average of 2.9 miles an hour and raised their heart rates to 47 percent of capacity. They said 48 people completed the six-month study.
“We observed improvements in aerobic fitness, motor function, fatigue, mood, and aspects of executive functions and quality of life,” Uc’s team wrote in the journal Neurology.
“Aerobic walking may represent an accessible, low-risk supplemental treatment for fatigue and depression, and improve quality of life in Parkinson’s disease as in aging, primary depression, cancer, and other chronic medical conditions.”
The federal government recommends that adults get 150 minutes per week of moderate exercise —that’s just half an hour a day, five days a week, but hardly any Americans meet that goal.
It’s just the latest in a series of studies that show exercise, especially walking, can help prevent Alzheimer’s disease, stroke, heart disease and depression. It can even help you live longer.

Friday, September 19, 2014

TOZADENANT CLINICAL TRIALS FOR PARKINSON'S DISEASE

19th September 2014 - New research


Lancet Neurology [2014] 13 (8) : 767-776 (R.A.Hauser, C.W.Olanow, K.D.Kieburtz, E.
Pourcher, A.Docu-Axelerad, M.Lew, O.Kozyolkin, A.Neale, C.Resburg, U.Meya, C.Kenney,
S.Bandak) Complete abstract : http://www.ncbi.nlm.nih.gov/pubmed/25008546

Clinical trials assessed the use 60mg, 120mg, 180mg, or 240mg tozadenant in people with
Parkinson's Disease who were being treated with L-dopa and who had motor fluctuations that involved at least 2·5 hours off-time per day. Tozadenant (SYN115) is an inhibitor of the adenosine 2a (A2a) receptor that is being developed for the treatment of Parkinson's Disease.

Compared with the use of a placebo, daily off-time was reduced by more than an hour when taking either 120mg or 180mg tozadenant. The most common adverse events were dyskinesia (16% of people taking 120mg, 20% of people
taking 180mg), nausea (11% of people taking 120mg, 12% of people taking 180mg), dizziness (5% of people taking 120mg, 13% of people taking 180mg). Tozadenant, 60 mg twice daily, was not associated with a significant reduction in off-time. Tozadenant, 240 mg twice daily, was associated with an increased rate of discontinuation because of adverse events that occurred in 20% of people taking that dosage. The researchers concluded that Tozadenant at 120 or 180 mg twice daily was generally well tolerated and was effective at reducing off-time. Further investigation of tozadenant treatment in phase 3 trials is warranted.



http://www.viartis.net/parkinsons.disease/news/140919.pdf

For more information go to Biotie Therapies : 
http://www.biotie.com/en/product_portfolio/product_portfolio/syn115



Tozadenant (SYN115): A highly differentiated product for Parkinson’s disease

Biotie is developing a novel product, tozadenant (SYN115) for Parkinson´s disease. The product has a unique mechanism of action and, if successful, could represent the first new treatment modality for this disease in more than 20 years. Biotie owns full global rights to tozadenant and is currently evaluating the most suitable development strategy for this Phase 3 ready asset to maximize its value to Biotie’s shareholders, including considering new partnerships to assist in the development and commercialization of tozadenant.
About Parkinson’s disease
Parkinson’s disease is a progressive neurodegenerative condition that is associated with four common motor symptoms:  tremor of the hands, arms, legs, jaws, and or face; rigidity or stiffness of the limbs and trunk; slowness of movement and impaired balance or coordination.  As the disease progresses the conditions become more pronounced and patients have difficulty walking, talking and completing simple daily tasks. Eventually patients are restricted to a bed or a chair and require constant nursing care. Parkinson’s disease is also frequently associated with co-morbid, non-motor symptoms including depression, dementia, psychosis, and sleep disorders. These may be as disabling as, or more disabling than, the motor symptoms.
The symptoms of Parkinson’s disease are related to the death of neurons that produce the chemical messenger dopamine in regions of the brain controlling movement. The non-motor symptoms experienced by Parkinson’s patients are likely secondary to the underlying loss of dopaminergic neurons and potentially other types of neurons (cholinergic, serotonergic and adrenergic).
Parkinson’s disease is one of the most common neurodegenerative disorders occurring with an incidence second only to that of Alzheimer’s disease and a prevalence in the US, five major EU countries (5MEU) and Japan of approximately 1.6 million (footnotes a, b). The average age of onset is 60 years and, as the risk of developing Parkinson’s disease increases with age, its prevalence is expected to increase as the global population ages.
There are currently no available therapies that are capable of curing Parkinson’s disease and so the goal of therapy is to reduce symptoms to allow patients to perform usual daily activities. Existing therapies include levodopa (L-Dopa), dopamine agonists and the dopamine extenders. These have limited efficacy, are associated with significant side effects (including dyskinesias, or sudden jerking movements) and their effects diminish over time, leaving patients with re-emergence of symptoms before their next dose (‘wearing off’).  New therapeutic modalities that improve control of motor symptoms, delay the time to use of L-Dopa, reduce troublesome side effects, treat some of the non-motor symptoms such as dementia, depression, sleep disorders, and which slow progression of the disease are needed and will drive market growth. 

Product profile for tozadenant (SYN115)
SYN115 is an orally administered, potent and selective inhibitor of the adenosine 2a (A2a) receptor that is being developed initially for the treatment of Parkinson’s disease, but may also have utility in other CNS disorders.
A2a receptors are expressed in high concentration in the striatum of the brain and there is an emerging body of evidence that they play an important role in regulating motor function. SYN115 blocks the effect of endogenous adenosine at the A2a receptors, resulting in the potentiation of the effect of dopamine at the D2 receptor and inhibition of the effect of glutamate at the mGluR5 receptor. This enables restoration of motor function in Parkinson’s disease patients without the induction of troublesome dyskinesias. SYN115 has the potential for use as mono-therapy or adjunctive therapy in combination with L-Dopa and dopamine agonists for the treatment of the motor and non-motor symptoms associated with Parkinson’s disease. 
SYN115 may also have neuroprotective effects, which raises the possibility that it could slow the deterioration of dopamine producing cells and modify disease progression – a holy grail in Parkinson’s disease.

Clinical trial status of SYN115
SYN115 was initially studied in a single ascending dose study, two multiple ascending dose Phase 1 studies and a Phase 2a study in L-Dopa treated subjects with mild-to-moderate Parkinson’s disease. In these studies l, a total 127 normal volunteers and Parkinson’s disease patients received SYN115 for up to 28 days, at doses ranging from 5mg to 480mg per day (dosed once or twice daily). In these clinical studies, SYN115 was shown to be safe and well tolerated. In the Phase 2a study, sophisticated imaging techniques (fMRI) were used to evaluate the effect of SYN115 on the brain. The results showed that SYN115 enters the brain and causes changes in functional activity in specific regions associated with motor function and cognition. Improvements in various clinical assessments of motor function and cognition have also been demonstrated.
In April 2011, Biotie commenced a randomized, double-blind, placebo-controlled Phase 2b study that evaluated four doses of SYN115 versus placebo as adjunctive therapy in 420 levodopa-treated PD patients with end of dose wearing off.  In these patients, treatment with levodopa is insufficient to control Parkinson’s disease symptoms until their next dose, resulting in an 'off' period when symptoms reappear. The aim of the Phase 2b study was to determine the efficacy and safety of SYN115 in reducing the mean time spent in the 'off' state over a 12 week treatment period. The trial also assessed the impact of SYN115 on various measures of motor symptom severity, dyskinesia and non-motor symptoms. Enrolment in the study was completed in July 2012 and top-line data reported in December 2012. In this study, tozadenant displayed clinically relevant and statistically highly significant effects on Parkinson’s disease across multiple pre-specified evaluation metrics including: a decrease vs. placebo in 'off' time, an increase in 'on' time, an improved score on UPDRS part III  and UPDRS parts I-III combined, as well as improvements on clinician- and patient-assessed global impression scores. Additionally, the study identified the minimally efficacious and maximum feasible dose levels, as well as clinically useful target doses for Phase 3. Tozadenant was generally well tolerated in the study.
Extensive data from the Phase 2b study have been presented at the 65th Annual Meeting of the American Academy of Neurology (AAN) in San Diego, March 20, 2013. as well as in the 17th International Congress of the Movement Disorder Society in Sydney, June 2013.

Program status

 Following an agreement announced in 2010, Biotie licensed worldwide exclusive rights to UCB Pharma S.A. (UCB) in February 2013 and received a one-time payment of USD 20 million Following an agreement announced in 2010, Biotie licensed worldwide exclusive rights to UCB Pharma S.A. (UCB) in February 2013 and received a one-time payment of USD 20 million (Stock exchange release; February 27, 2013); a potential additional USD 340 million in future milestone payments were payable under the agreement with UCB.

Tozadenant is now transitioning into Phase 3 development. Since February 2013, preparations for the Phase 3 development program were undertaken in collaboration with UCB; these included CMC and non-clinical work, and certain Phase 3 enabling clinical pharmacology studies for which Biotie received EUR 9.7 million in additional development milestones in 2013. Patient enrolment in the phase 3 program is currently planned to commence by the first half of 2015.

In March 2014, it was announced that UCB were returning global rights to tozadenant to Biotie after UCB's assessment of its early and late stage clinical development pipeline, as well as its preclinical opportunities, and did not reflect any concerns regarding safety or efficacy of tozadenant. UCB has confirmed that it will meet all its contractual and scientific commitments regarding the ongoing development program for tozadenant, including conducting together with Biotie the scheduled End-of-Phase 2 meeting with US Food and Drug Administration in H1 2014. The companies are working together to execute an appropriate transfer of the program back to Biotie.

Owning full global rights to tozadenant will enable Biotie to evaluate the most suitable development strategy for this Phase 3 ready asset to maximize its value to Biotie’s shareholders. As part of this evaluation Biotie will consider other partners to assist in the development and commercialization of this novel compound.