CLINICAL TRIALS IN PROGRESS Updated: July 1, 2009
APLIED: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Three Doses of Aplindore MR (1, 3, and 6 mg twice daily) in Patients with Early Parkinson Disease ...Recruitment for APLIED is on hold...
The Parkinson Study Group (PSG) is conducting a study of the research medication aplindore in men and women who are at least 30 years of age and have been diagnosed with early Parkinson Disease (PD) within the last 5 years. APLIED is designed to determine how safe and effective aplindore is in treating subjects with PD.   The study will also look at how aplindore affects thinking and memory, mood, behavior, impulse control and daytime sleepiness. Approximately 42 sites within the United States will enroll roughly 5 subjects per site over the next 7 months. The study is sponsored by Neurogen Corporation. If you are interested in learning more about this study, please contact the Parkinson Study Group toll free at 1-888-887-3774. This trial is also listed on the ClinicalTrials.gov web site.
Effects of Coenzyme Q10 in Parkinson Disease – Phase 3 (QE3) ...Recruitment for QE3 is now in progress...
The Parkinson Study Group (PSG), under the direction of Principal Investigators Neurologist Flint Beal, MD (Weill Medical College of Cornell University) and Biostatistician David Oakes, PhD (University of Rochester) and Co-Principal Investigator Neurologist Ira Shoulson, MD (University of Rochester), is conducting a multi-center, randomized, double-blind, placebo-controlled study of Coenzyme Q10 (CoQ) in individuals with Parkinson disease. The objective of this study, called ‘QE3’, is to evaluate the safety and effectiveness of high dosages of CoQ in slowing clinical decline in patients who have early Parkinson disease. Current medications are able to treat many of the symptoms of Parkinson disease, but there is no treatment to slow disease progression. CoQ is a naturally occurring substance in the body and is also a nutritional supplement. The CoQ in this study, which will also contain vitamin E, is being studied as an investigational drug at higher dosages and, in previous studies, has been well tolerated with no serious safety issues reported. Participants 30 years of age or older, diagnosed with Parkinson disease within the last 5 years, and are not yet receiving symptomatic treatment may be eligible for the study. Study doctors will follow participants every four months over a 16 month period. Researchers at approximately 60 clinical sites in the United States and Canada will enroll a total of 600 research subjects with early signs of Parkinson disease. Each center will enroll approximately 10 participants. Enrollment began in January 2009. This study is sponsored by the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health (NIH). If you are interested in learning more about this study, please contact the Parkinson Study Group toll free at 1-888-887-3774. This trial is also listed on the ClinicalTrials.gov web site. For a list of participating centers, see the QE3 Participating Site List.
PROGENI: Parkinson's Research: The Organized GENetics Initiative ....Recruitment for PROGENI is now in progress...To obtain additional information call 1-888-830-6299. Outside the United States, call 1-317-274-5734.
PROGENI (Parkinson's Research: The Organized GENetics Initiative) is a NIH-funded collaborative effort of the PSG, Indiana University, and University of Cincinnati. With Tatiana Foroud, PhD (Indiana University) as Principal Investigator, this initiative seeks to identify the gene or genes that predispose an individual to develop Parkinson's disease. This project identifies and recruits individuals with PD who have a living or deceased parent, child, or sibling who has/had PD. In total about 1800 individuals' DNA will undergo genetic analysis. Coupled with occupational, environmental and other risk factor data, the genetic information is expected to improve pre-clinical detection of Parkinson's disease and thereby foster the development of more effective therapies. This project is currently seeking participants. For additional information please visit the PROGENI website.

FOUND Project: (FOllow-Up of Persons with Neurologic Diseases) ...Recruitment for FOUND is in progress (although this is not a clinical trial)...

The goal of the PSG (Parkinson Study Group) FOUND (Follow-up of Persons with Neurologic Diseases) project in this early phase is to come up with a method for future follow-up of clinical trial subjects after the end of the trial, by using simple methods. Subjects are being recruited from two trials, which include persons with early, mild disease. In the next phase of this study, clinic subjects with moderate and advanced disease and subjects from epidemiologic studies will also be included. The goals of the first phase was to enroll and retain 100% of the clinical trial subjects and to develop a well-organized method for maintaining contact with participants through use of self-report questionnaires mailed three times a year. This is mostly important in chronic diseases such as Parkinson’s disease where the disease may last for decades. We hope to learn of the similarities and differences between clinical trial participants and the entire population of persons with Parkinson’s disease (PD). Knowing that information on the later course of the disease is the hardest to get, an easy, low-cost method for getting important information is desirable. Making the study larger to include clinical subjects and subjects from epidemiologic studies allows us to look at how useful these forms are for subjects with more advanced disease.

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