Parkinson's Disease

Research Studies

A long term, double-blind, randomized, parallel-group, carbidopa/levodopa controlled, multi-center study to evaluate the effect of Stalevo® in patients with Parkinson's disease requiring initiation of levodopa therapy [STRIDE-PD].

The purpose of this study is to investigate if, when used as an initial therapy, the optimized levodopa medication Stalevo (containing levodopa, carbidopa and entacapone) delays the onset of motor complications, such as dyskinesias, in comparison with the traditional formulation of levodopa/carbidopa.

We are looking to enroll approximately 10 volunteers. Eighteen (18) outpatient visits are planned, and subject participation may last up to three years.

You may be eligible for participation in this study if you are a male or female volunteer:

• Age 30-70 years old
• Diagnosed with Parkinson's disease for not more than five years
• Not previously exposed to Sinemet (levodopa/carbidopa)

For more information, please contact the study coordinator at (212) 241-4633. Principal Investigator: Winona Tse, M.D., BRANY IRB file No.04-02-241-05 approved through 5/31/06.

Study of the safety, tolerability and efficacy of Spheramine ® implanted bilaterally into post-commissural putamen of patients with advanced PD [STEPS]

The purpose of this study is to evaluate the effect and safety of Spheramine ® implantation in patients with Parkinson's disease. Spheramine is a cell therapy that consists of human retinal pigment epithelial (RPE) cells attached to microscopic gelatin beads (microcarriers). The RPE cells produce L-DOPA and are believed to directly enhance brain levels of dopamine.

Participation in the clinical trial will be for approximately two years and three months and consist of 17 study visits. Subjects are expected to have annual follow-up visits for at least five years thereafter.

You may be eligible to participate in this trial if you:

• Have had Parkinson's disease for at least five years and are in advanced stages of disease
• Are age 30 to 70 years old
• Currently experience insufficient control of your Parkinson's disease symptoms even with optimal oral medication treatment
• Respond to levodopa treatment

For more information, please contact the study coordinator at (212) 241-4633. Principal Investigator: Michele Tagliati, M.D., BRANY IRB #05-1211NE approved through 10/11/06.

A multicenter, Double-Blind, Randomized Start, placebo–controlled, parallel-group study to assess disease progression Effect of Rasagiline Mesylate in Early PD patients. [ADAGIO]

The purpose of this study is to evaluate whether treatment with rasagiline, a new drug for Parkinson's disease, can modify the progression of Parkinson's disease (PD). Findings from pre-clinical studies have previously shown that rasagiline has neuroprotective properties which have the potential to translate into a clinical effect on the progression of disability in PD.

The ADAGIO study will enroll approximately 1,100 patients at about 135 centers in 14 countries. We are seeking to enroll about 10 patients. If you qualify and decide to participate, you will be asked to come for 12 study visits over the next 18 months.

You may be eligible to participate in this trial if you:

• Have been diagnosed with PD for less than 1½ years
• Do not require any symptomatic therapy as yet

For more information, please contact the study coordinator at (212) 241-4633. Principal Investigator: Michele Tagliati, M.D., BRANY IRB #05-1286NE approved through 10/19/06.

A two-year, open label, randomized, parallel group, blinded assessment ophthalmologic safety study of pramipexole ir versus ropinirole in early Parkinson's disease patients

The purpose of this study is to determine if there is any difference in the presence of retinal deterioration in Parkinson's disease patients treated with pramipexole versus ropirinole as monitored by a comprehensive ophthalmology assessment from the baseline to the end of the study at two years.

We are seeking to enroll about 15 subjects. If you qualify and decide to participate, you will be asked to come for study visits over the next 24 months (two years). Some of the visits will take several hours (at least a half day) to complete, depending on the number of tests and evaluations done at the visit. Besides seeing the study doctor (neurologist), you will be required to visit an eye doctor for eye exams and testing four times over the next two years.

You may be eligible to participate in this study if you:

• Have had a diagnosis of Parkinson's disease for less than seven years (staged 1-3)
• Have a maximum of six months lifetime exposure to dopaminergic therapy
• Are age 30 years or older

For more information, please contact the study coordinator at (212) 241-4633. Principal Investigator: Winona Tse, M.D., BRANY IRB #05-0572NE approved through 3/28/06.

Clinical Evaluation of bilateral stimulation of the STN using the ANS Totally Implantable DBS System (Libra ®).

The purpose of this study is to demonstrate the safety and efficacy of bilateral stimulation of the subthalamic nucleus (STN) when using the ANS Libra DBS System as an adjunctive treatment for reducing some of the symptoms of advanced,levodopa-responsive Parkinson's disease that are not adequately controlled with medication.

We are seeking to enroll about 15 patients in this study, which explore a new device for deep brain stimulation.

You may be eligible to participate in this study if you:

• Are 18 to 80 years old
• Are diagnosed with PD for at least 5 years
• Respond to Levodopa
• Have moderate to severe dyskinesia

For more information, please contact the study coordinator at (212) 241-4633. Principal Investigator: Michele Tagliati, M.D., BRANY IRB #05-1244NE approved through 9/6/06.

The MOST Study: Mood and STN DBS

The purpose of this study is to examine the impact of STN DBS on mood. Specifically, we will characterize mood changes following STN DBS and whether psychiatric co-morbidities place patients at risk for them; we will examine whether mood effects are influenced by unilateral versus bilateral implantation of DBS and elucidate when mood effects – if any – occur. Finally, we will follow patients to track their outcomes and document whether mood effects of DBS were treatable with medications and/or device adjustments.

We are seeking to enroll about 30 patients in the next three years. Every candidate for bilateral STN DBS will be offred to participate in the study.

• You may qualify to participate in this study if you are a candidate for bilateral STN DBS and if you:
• Have diopathic PD, as diagnosed by a movement disorders neurologist.
• Developed medication refractory PD with on-off fluctuations.
• Do not have dementia
• Did not have prior neurosurgical intervention.

For more information, please contact the study coordinator at (212) 241-4633. Principal Investigator: Michele Tagliati, M.D., IRB protocol #05-0367 approved through 6/30/06.

Hepatocerebral Parkinsonism

We hypothesize that the parkinsonian syndrome associated with liver failure is distinct from idiopathic Parkinson's disease and is due to manganese intoxication caused by decreased biliary clearance. Confirmation of the latter hypothesis would be significant in developing strategies to prevent and treat parkinsonism in patients with liver failure.

We are planning to enroll six patients with liver cirrhosis and parkinsonism (tremor, rigidity, gait abnormalities, or bradykinesia). Principal Investigator: Catherine Cho, M.D., GCO #05-0137.

Emotional Processing in PD

The purpose of this study is to observe and determine the presence and characteristics of emotional processing deficits in individuals suffering from Parkinson's disease compared to normal subjects. Emotional processing deficits are abnormal changes in mood such as depression or anxiety or the inability to react emotionally. Principal Investigator: Winona Tse, M.D., IRB #04-936.