The Effect of Methylphenidate on Non-motor Symptoms and Postural Control in Parkinson's Disease....
Parkinson's DiseaseThis project aims to determine if methylphenidate can improve deficits in attention and symptoms of orthostatic hypotension, two common non-motor symptoms, in patients with Parkinson's Disease. This project also seeks to evaluate the effect of methylphenidate on postural control in these patients, a debilitating motor symptom that places patients at an increased risk of falling. This study will build on existing data to support a new indication for the use of methylphenidate in Parkinson's Disease. Using standard and objective evaluations, this study will quantify the effect of methylphenidate at two doses on attention levels, orthostatic hypotension, and measures of postural control. Phase I of the study will compare methylphenidate 10mg three times daily to placebo and Phase II of the study, for those tolerating the lower dose in Phase I, will compare methylphenidate 20mg three times daily to placebo. By incorporating two different doses, the study also seeks to determine if any improvements are dose-related. Secondary endpoints will include safety assessments (adverse event monitoring and vital signs) performed every 30 minutes following supervised drug administration. Visual analog scales will be presented to each participant before treatment and following the final dose of each treatment to assess changes in fatigue. A secondary task will be added to postural tests to assess the influence of cognitive processes. It is hypothesized that methylphenidate will demonstrate a significant beneficial effect on all outcomes. It is projected that objective improvements will be observed following treatment with methylphenidate at both doses (10 and 20mg three time daily) when compared to placebo. It is further hypothesized that the effects will be dose-related and therefore more profound with higher doses.
A Placebo- and Active-Controlled Study of Preladenant in Early Parkinson's Disease (PD) (P05664)...
Parkinson DiseaseThis is a one year, 2-part study to determine the efficacy and safety of preladenant, an adenosine type 2a (A2a) receptor antagonist. The purpose of Part 1 (first 26 weeks) is to determine if preladenant is effective in the treatment of early Parkinson's Disease. The purpose of Part 2 (second 26 weeks) is to determine if preladenant is safe and well tolerated. The primary efficacy hypothesis is that at least the 10 mg twice daily dose of preladenant is superior to placebo as measured by the change from Baseline to Week 26 in the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Parts 2 and 3 scores (UPDRS2+3).
Treating H. Pylori in Parkinson's Patients With Motor Fluctuations
Parkinson's DiseaseHelicobacter Infections1 moreThe purpose of this study is to determine whether treatment of H. pylori (an infection of the stomach) improves treatment effectiveness in patients with Parkinson's disease and motor fluctuations.
Efficacy and Safety Study of Aplindore in Patients With Early Parkinson Disease
Early Parkinson DiseaseThis is a clinical trial to be conducted at multiple Parkinson Study Group (PSG) sites in the USA. Patients with early Parkinson disease will be randomly allocated to one of 4 arms in the study. The 4 arms include 3 arms with different doses of aplindore MR tablets and 1 placebo arm. The study drug will be taken twice a day (BID). The study is blinded and neither subjects, nor the investigators, will know what treatment the subject is receiving. Investigational study drug will be adjusted to the assigned dosage and then maintained at that dosage for the balance of the 12 week follow-up period. The entire study will take about 13 weeks. The study will assess the safety and tolerability of aplindore and measure how effective aplindore is in improving movement and other effects of Parkinson disease.
Effects of Coenzyme Q10 (CoQ) in Parkinson Disease
Parkinson DiseaseThe purpose of this study is to evaluate the safety and effectiveness of high dosages of Coenzyme Q10 in slowing clinical decline in people who have early Parkinson disease.
PET-Study: Effects of Single Doses of Stalevo and Levodopa/Carbidopa on Striatal 11C-Raclopride...
Parkinson´s DiseaseThis is an open, randomised, active-controlled, 2-period crossover study comparing the effect of single doses of Stalevo 200 and Sinemet on striatal (putamenal and caudate) 11C-raclopride BP in PD patients with wearing-off symptoms. The study consists of 4 visits: a screening visit (visit 1), 2 treatment periods (period 1=visit 2, period 2=visit 3) separated by a minimum wash-out period of at least 3 days, and an end-of-study visit (visit 4). Subjects will be randomly allocated to start the period 1 with a single dose of Stalevo 200 or Sinemet. After the wash-out the study drug on period 2 will be administered according to a crossover design.
Clinical Effects of Vitamin D Repletion in Patients With Parkinson's Disease
Parkinson's DiseaseRetrospective review of records in the Emory Movement Disorders clinic suggests vitamin D deficiency occurs in over 80% of patients with Parkinson's Disease (PD), much more frequently than in internal medicine clinics. Laboratory studies have suggested vitamin D could play a role in the development of PD. In addition, low vitamin D levels have been associated with slower walking speeds, worse memory and thinking, and depression.
Ramelteon (ROZEREM) in the Treatment of Sleep Disturbances Associated With Parkinson's Disease
Parkinson's DiseasePatients with Parkinson's disease represent a significant proportion of VA elderly patients. Sleep disturbances and caregiver burnout association with this condition represent a significant problem. In this study, the investigators propose to perform an evaluation of a fixed doe of ramelteon on sleep in VA outpatients diagnosed with Parkinson's disease. The hypothesis to be examined is that ramelteon will improve the quality of sleep in patients with Parkinson's disease while indirectly improving the quality of life for the patients and caregivers. The investigators further hypothesize that these changes will occur through restructuring and normalization of the sleep architecture.
Proof of Concept BeatPark
Parkinson's DiseasePhysical activity has demonstrated its beneficial effect on functional capabilities and quality of life in patients with PD. However, the daily physical activity remains limited in these patients. Rhythmic auditory cueing improves spatio-temporal gait parameters in patients with PD. The first results of BeatHealth studies have allowed us to identify the best musical stimulation to improve these parameters and the motivation of the patients. The originality of this study is to propose a gait auto-rehabilitation program using BeatHealth device with optimal auditory cueing during four weeks in ecological conditions in PD. Observance (utilization's time), safety (falls, pain, fatigability) and efficacy (gait parameters, balance, quality of life) will be evaluated.
Buspirone, in Combination With Amantadine, for the Treatment of Levodopa-induced Dyskinesia
Parkinson's DiseaseDyskinesias1 moreThe primary objective of this study is to evaluate the efficacy of buspirone in combination with amantadine in reducing levodopa-induced dyskinesia (LID) in patients with Parkinson's disease (PD).