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Parkinson's Disease clinical trials

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NCT ID: NCT01003535 Completed - Parkinson´s Disease Clinical Trials

Quantification of Cerebral Cholinergic Function in Parkinson´s Disease by Means of Nuclear Medicine Methods

Start date: January 2010
Phase: Phase 1
Study type: Observational

Parkinson´s disease is based on a Lewy body degeneration of cerebral and extracerebral neurons. This Lewy body degeneration includes cerebral cholinergic neurons besides dopaminergic neurons. In previous studies the investigators found that some clinical parkinsonian symptoms - primarily hypokinesia and rigidity - significantly correlate with the dopaminergic nigrostriatal degeneration which was quantified by dopamine transporter imaging. In contrast to that, resting or postural parkinsonian tremor does not correlate with the dopaminergic nigrostriatal degeneration. Obviously further cerebral changes - for instance possible changes / degeneration of cerebral cholinergic neurons - contribute to parkinsonian tremor. In this study the investigators apply cerebral 5-IA-85380-SPECT to quantify the local density of cerebral nicotinergic cholinergic receptors in patients with Parkinson´s disease. The investigators will correlate the results of cerebral 5-IA-85380-SPECT with the clinical parkinsonian main symptoms hypokinesia, rigidity and primarily resting and postural tremor. In particular, it is of interest whether changes of cerebral cholinergic neurons are involved in the generation of parkinsonian tremor.

NCT ID: NCT00999388 Completed - Parkinson's Disease Clinical Trials

Shanghai Parkinson's Study

Start date: October 14, 2009
Phase:
Study type: Observational

Background: - Parkinson disease (PD) is the second most prevalent neurodegenerative disease, affecting more than 1 percent of the elderly population in the United States and other Western countries. Although effective treatments can alleviate symptoms in early PD, no cure or treatment slowing disease progression has been identified, and patients will eventually develop severe physical and mental disabilities and often die of complications. More research is needed on the causes of and appropriate preventive strategies for PD. - The Shanghai Women s Health Study (SWHS) was established 10 years ago by investigators from the Vanderbilt University, the Shanghai Cancer Institute (SCI) and the National Cancer Institute (NCI) of the US. Their primary aim was to examine several unique dietary hypotheses on cancer among Chinese women. Researchers from the National Institute of Environmental Health Sciences and SWHS investigators are now interested in studying PD patients from SWHS to evaluate biological and environmental factors that may have put them at risk for PD. Objectives: - To initiate a long-term prospective study on PD in Chinese women from the Shanghai Women s Health Study. - To examine a set of biological and environmental factors that may raise or lower risk of developing PD. Eligibility: - All participants of the SWHS cohort are eligible. Design: - Researchers will contact self-reported PD cases from the SWHS, confirm (or reject) the self-report, and invite them to a clinical examination at a coordinating hospital in Shanghai. - Cases that confirm the self-report will be invited to visit the coordinating hospital for clinical examinations, including a PD clinical workup, blood and urine collections, a cognitive assessment and relevant neuropsychological testing, and an interview on additional risk factor exposures that are not available from baseline surveys. - For those who could not participate in the clinical examination, researchers will ask for a few details about the diagnosis and treatment history and ask for permission to obtain medical records relevant to PD diagnosis from government or hospital agencies. - For self-reported PD cases who are now deceased, researchers will follow a similar procedure by asking for consent and help from the next-of-kin.

NCT ID: NCT00998660 Completed - Parkinson's Disease Clinical Trials

RECHARGE Sub-Study to the Implantable Systems Performance Registry (ISPR)

RECHARGE
Start date: July 2009
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the recharge feature of the Activa RC System in patients who are receiving Deep Brain Stimulation (DBS) for Parkinson's Disease (PD), Essential Tremor (ET), or dystonia.

NCT ID: NCT00982709 Completed - Parkinson's Disease Clinical Trials

The Effects of Treadmill Versus Agility Training in Parkinson's Disease

Start date: January 2009
Phase: N/A
Study type: Interventional

Aim: To determine the Responsiveness of the iMOBILITY in response to intensive physical therapy exercise programs. (Is it sensitive to change?) Although exercise is thought to be the most effective intervention for balance and gait in PD (compared to dopaminergic medication or DBS surgery), the best exercise program for mobility in PD is unknown. The iMOBILITY will be used to quantify balance and gait performance before and after two PT-supervised, intensive, exercise programs, expected to improve balance and gait. The first program is a published Treadmill training program and the second is the investigators new Agility training program with sensorimotor progressions, targeted at specific impairments that underlie the abnormalities of balance and gait in PD (developed for the Kinetics Foundation). This pilot clinical trial will randomize 40 PD subjects into the two exercise programs at OHSU in preparation for a larger clinical trial to determine the most effective exercise for mobility disability in PD. The effects of exercise will be compared with no treatment during a 5-week delay prior to start of exercise. This trial will also determine the relative responsiveness (compared to traditional clinical scales) of the iMOBILITY for testing the hypothesis that intensive exercise can improve mobility in PD. We will use existing instruments (Berg Balance Scale, BEST of dynamic balance, UPDRS, PDQ-39, 5 times sit-to-stand time and the Functional Performance Battery) to show there is a difference between the exercise groups. Superior responsiveness of the iMOBILITY system will be determined by larger differences with exercise intervention with the iMOBILITY system than with traditional clinical measures of mobility in PD.

NCT ID: NCT00974974 Completed - Parkinson's Disease Clinical Trials

A Study To Evaluate The Safety And Efficacy Of IPX066 In Advanced Parkinson's Disease (ADVANCE-PD).

Start date: September 2009
Phase: Phase 3
Study type: Interventional

This is a study to evaluate the safety and efficacy of IPX066 in advanced Parkinson's disease.

NCT ID: NCT00964652 Completed - Parkinson´s Disease Clinical Trials

Treadmill Training With Additional Body Load: Effects on Gait of Subjects With Parkinson´s Disease

Start date: August 2007
Phase: N/A
Study type: Interventional

Background: Studies about the effects of walking training with additional body load in Parkinson's disease (PD) are lacking. There is evidence that the increase of body load during treadmill walking improves reflex activity and leg extensor muscle activity, which are impaired in subjects with PD. Purpose: The purpose of this study was to assess the effects of treadmill walking training with additional body load on the ground reaction forces, spatiotemporal, and kinematic variables of the gait of subjects with moderate PD. Design: This study was an A1-B-A2 single-case. Setting: The evaluation and the training were conducted in a movement analysis laboratory, and at the rehabilitation unit of the University, respectively. Participants: Nine patients with PD (Hoehn and Yahr 2 through 3) and gait disturbances. Interventions: Phases A1 and A2 included 6 weeks of gait training on a treadmill with 10% increase of normal body mass. Phase B included 6 weeks of conventional physical therapy. Measurements: Measures included the ground reaction forces, spatiotemporal, and kinematic variables during overground walking, at baseline and after each phase.

NCT ID: NCT00957918 Completed - Parkinson's Disease Clinical Trials

Study of NP002 in Subjects With Idiopathic Parkinson's Disease to Treat Dyskinesias Due to Levodopa Therapy

Start date: October 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The study is designed to answer the question: will nicotine at doses that do not cause serious side effects, show feasibility in treatment of levodopa-induced dyskinesia in patients with Parkinson's disease?

NCT ID: NCT00957203 Completed - Parkinson's Disease Clinical Trials

Long-Term Safety Study of KW-6002 (Istradefylline) in Parkinson's Disease Patients

6002-010
Start date: October 2009
Phase: Phase 3
Study type: Interventional

Patients with Parkinson's disease who completed the prior double-blind study 6002-009 are eligible to enter into this long-term study. The purpose of this study is to evaluate the safety and efficacy of KW-6002 administered long-term in patients with advanced Parkinson's disease treated with levodopa.

NCT ID: NCT00955526 Completed - Parkinson's Disease Clinical Trials

Study of KW-6002 (Istradefylline) for the Treatment of Parkinson's Disease in Patients Taking Levodopa

6002-009
Start date: July 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to establish the efficacy of 20 mg/day and 40 mg/day doses of istradefylline for reducing the mean total hours of awake time per day spent in the OFF state in patients with advanced Parkinson's disease (PD) treated with levodopa. Patients who meet entry criteria will be randomized in a 1:1:1 ratio to double blind treatment with oral doses of 20 or 40 mg/day istradefylline or matching placebo. Patients will be treated for 12 weeks and will have interim visits and end of treatment visit to assess the efficacy and safety of istradefylline.

NCT ID: NCT00955318 Completed - Parkinson's Disease Clinical Trials

Long-Term Safety Study of KW-6500 in Patients With Parkinson's Disease

Start date: July 2009
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of KW-6500 when administered as long-term subcutaneous self-injections in Parkinson's disease patients with motor response complications on levodopa therapy.