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International trial of new drug to treat Parkinson’s-related behavior & perception problems (affecting 40% of cases) – now recruiting

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www.ProHealth.com • December 14, 2008


Online survey finds many patients and caregivers unprepared for the mental and behavioral changes associated with the disease

Parkinson’s disease affects 6.3 million people worldwide. While the disease is recognized for its profound effects on movement, up to 40 percent of Parkinson’s disease patients also develop changes in thought, behavior and judgment.

As Parkinson’s disease progresses, patients may experience what is called ‘Parkinson’s Psychosis,’ in which they experience changes in thought, behavior and judgment. In more advanced stages these symptoms include hallucinations where patients see, hear or feel things that aren’t really there, and paranoid delusions where they become distrustful of even their closest friends and family members. The emergence of these symptoms represents a major turning point in the course of the patient’s disease.

“While the physical manifestations of Parkinson’s disease are difficult to deal with, the changes in thought, behavior and judgment strain the bonds between patients and their caregivers and families,” said Dr. Bernard Ravina, Director of the Movement and Inherited Neurological Disorders Unit at the University of Rochester in New York.

Many Caregivers Unprepared

According to an on-line survey recently conducted by MediciGlobal, a global patient recruitment and retention specialty firm, over one-third of Parkinson’s caregivers are unaware that changes in thought, behavior, and judgment can accompany the disease. “As a registered nurse, I was prepared for the physical problems with my husband’s Parkinson’s disease but, despite my job as a RN, I was totally unprepared for the psychiatric issues,” said Carol McLain, a caregiver who took the survey.

According to Dr. Ravina, “It’s the non-physical symptoms of the disease that are often most devastating for both the patient and caregiver. As the patient’s mental health deteriorates, the family often has to make the painful and expensive decision of moving the patient into a nursing home.”

There are currently no FDA-approved treatments for these particular non-physical symptoms of Parkinson’s disease. Nevertheless, doctors often resort to the use of potent antipsychotic drugs to treat these symptoms even though these drugs sometimes have serious side effects, particularly in the elderly, including worsening of motor skills, excessive sleepiness, increased infections, stroke, and sudden death in some patients. As a result, there is a large unmet medical need for new and improved treatment options.

Clinical Trial Recruiting at 65 Centers in US, UK, Four Other Countries

A clinical trial is currently recruiting people with changes in thought, behavior and judgment related to Parkinson’s disease to test whether their condition can be treated safely and effectively with a new investigational drug. The clinical trial, which is being conducted in the United States, UK, France, Bulgaria, Russia, and Ukraine, focuses on men and women who are:

• At least 40 years of age,

• Have an established diagnosis of Parkinson’s disease,

• And are currently experiencing changes in thought, behavior or judgment.

[According to the study website, the trial will be conducted "at approximately 65 research centers around the world. Participants will be asked to make 7 visits to the study center. This will include six weeks of study treatment and one month of follow-up. It is possible that at the end of the initial 6-week treatment period, the person you care for may have the opportunity to receive extended study treatment with the active investigational drug. The duration of this extended study treatment could be for as long as the study doctor believes the person you care for is benefiting."]

Those in the U.S. caring for someone who may be experiencing changes in thought, behavior and judgment associated with Parkinson’s disease are encouraged to call the toll-free study hotline at 1-866-565-0261 or visit the web site at http://www.ParkinsonsMindStudy.com to learn more about this clinical trial.

Those in the U.K. can visit http://www.ParkinsonsConcern.org.

Source: Dec 10 2008 news release of survey sponsor MediciGlobal




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