NEWYORK, NY — The Michael J. Fox Foundation for Parkinson’s Research today announced approximately $3.7 million in total funding for seven clinical research studies under its 2006 Clinical Discovery Program. This annual initiative provides funding for potentially high-impact Parkinson’s clinical research projects.

“Clinical Discovery is an important element of the Foundation’s continued focus on driving clinical and translational research,” said Gene Johnson, PhD, the Foundation’s chief scientific advisor. “We are enthusiastic and optimistic about the potential of the 2006 program not only to answer enduring questions about the disease, but also to help speed meaningful therapies and interventions to the millions living with Parkinson’s.”

The 2006 projects fall into three categories: improving existing therapies, addressing unmet needs of Parkinson’s patients and understanding Parkinson’s etiology and pathogenesis through studies in patient populations.

Improving Existing Therapies

• Eliahu Heldman, PhD, chief scientific officer of NeuroDerm, Ltd., an Israeli biotech firm, will develop a transdermal skin patch for continuous delivery of levodopa and conduct initial testing in human subjects. Continuous dopamine delivery systems have generated a great deal of interest among Parkinson’s researchers, because it is hypothesized that dyskinesias — disruptive, jerky movements associated with long-term levodopa therapy — result from the sharp fluctuations in dopamine blood levels that characterize oral administration of levodopa. But to date, all attempts at achieving continuous delivery have proved impractical or infeasible, and attempts to deliver levodopa transdermally have failed because, among other reasons, the drug is unstable and cannot penetrate the skin. NeuroDerm has innovated a system involving stabilizers and skin penetration enhancers, and has demonstrated early success in animal models, maintaining steady therapeutic levodopa blood levels with no intolerable side effects.
• Robert Chen, MA, MBBChir, MSc, FRCPC, of Toronto Western Research Institute, will focus on understanding the mechanism of action in deep brain stimulation (DBS) surgery and identifying ways to improve on current stimulation approaches. Dr. Chen’s team will examine electrical activity recorded directly from the basal ganglia (an area of the brain whose abnormal functioning is related to Parkinson’s) in patients undergoing DBS surgery. This will allow the researchers to determine the specific clinical effects of DBS in each individual. The results will lead to greater understanding of the functional organization of the basal ganglia, potentially improving current DBS approaches and expanding the population of patients who could benefit from stimulation-based treatment.

Addressing Patients’ Unmet Needs

Three projects reflect the Foundation’s commitment to drive research into “dopamine non-responsive” Parkinson’s symptoms, an array of troubling, largely non-motor aspects of the disease that many patients call more distressing than the better-known motor symptoms — but that nonetheless remain under-researched and poorly understood.

• Meg Morris, a physical therapist on the faculty of the University of Melbourne, Australia, will conduct a rigorous clinical study to test physical therapy approaches that could potentially prevent and treat falls in Parkinson’s patients. Results from this study could provide clinicians with a validated strength training and educational approach to limit falls and improve patients’ postural stability.
• Jau-Shin Lou, MD, PhD, of Oregon Health and SciencesUniversity, will investigate the physiological mechanisms responsible for fatigue, a common Parkinson’s symptom that dramatically detracts from quality of life.
• Emily Wang, PhD, of RushUniversityMedicalCenter, will test a device that provides patients with altered auditory feedback to improve speech problems, common in people with Parkinson’s. Patients wear the device in one ear and hear their own speech through it after a short time delay and with a shift in pitch while they speak. In preliminary testing, seven of eight patients who used the device made significant improvements in their speech, allowing them to express themselves more effectively with their families, caregivers and physicians. The researchers will next test the device for both short- and long-term gains in 20 patients over the course of one year.

Understanding Parkinson’s Etiology and Pathogenesis

• Jonathan Haines, PhD, of VanderbiltUniversity has identified a population of Ohio Amish in which several individuals are affected with Parkinson’s. He has completed initial work in this population to identify what he believes to be three novel genetic alterations associated with Parkinson’s, and will next attempt to find a novel causal gene for the disease.
• Brad Racette, MD, of WashingtonUniversity in St. Louis, will conduct a detailed study on the purported relationship between exposure to welding chemicals and Parkinson’s risk. Specifically, working with a cohort of welders, Dr. Racette will correlate lifetime exposures to welding chemicals with risk for Parkinson’s. Additionally, he will conduct neuroimaging studies on asymptomatic welders to determine whether they demonstrate any damage to the nigrostriatal system.

The Foundation launched the Clinical Discovery Program in 2004. Approximately $7 million has been awarded for 12 projects under the initiative to date.