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Parkinson's Disease clinical trials

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NCT ID: NCT01411137 Completed - Parkinson's Disease Clinical Trials

Carbidopa-Levodopa (CD-LD) ER Alone or in Combination With CD-LD IR to IPX066 Followed by IPX066 Extension Safety Study

Start date: August 2011
Phase: Phase 3
Study type: Interventional

The study had three distinct parts and is described as follows: Part 1: - To evaluate the dose conversion from CD-LD ER taken alone or in combination with CD-LD IR to IPX066 in subjects with advanced PD - To evaluate the utility of the Objective Parkinson's Disease Measurement (OPDM), an exploratory computer-based system, in assessing dexterity and mobility in a subset of PD subjects. Part 2: • To evaluate the long-term safety and clinical utility of IPX066 under open-label conditions in eligible subjects who successfully completed Part 1 of the study. Part 3: • To further evaluate the long-term safety of IPX066 in eligible subjects who successfully completed Part 2.

NCT ID: NCT01399905 Completed - Parkinson's Disease Clinical Trials

High and Low Dose Carbidopa Treatment of Parkinson's Disease

Start date: March 2009
Phase: Phase 2
Study type: Interventional

Hypothesis: We hypothesize that carbidopa in daily doses of 450mg will enter the central nervous system and partially inhibit AAAD, thereby reducing the decarboxylation of exogenous levodopa to dopamine, and thereby blunt the therapeutic effects of levodopa in PD subjects. The purpose of this study is to see how low dose vs. high dose of the study drug, carbidopa effect movement in subjects with Parkinson's disease. The low dose of the study drug is 75 mg and the high dose is 450mg. Subjects will be recruited from the investigators clinic when they are seen for treatment for Parkinson's disease. Subjects will also be recruited through flyers hung at OHSU and at the VA. Subjects will take part in 2 screening visits one week apart to determine eligibility. Subjects will be randomly chosen to start either high or low dose carbidopa and take it for 4 weeks. Subjects will be called 2, 4, and 6 or 7 days after this visit to ask how they are doing after starting this dose of study drug. We will leave them a message if we cannot reach them. If there are any problems, we will schedule them to come to the clinic within the next 2 days. Subjects will have an outpatient visit 2 weeks after screening and a hospital admission 2 weeks after that. At the hospital, subjects will stay for 3 days. They will have blood drawn and their Parkinson's disease assessed by a finger tapping exercise, timing their walking, and looking at their uncontrolled movements. The subject will then receive the opposite dose of carbidopa for 4 weeks. Subjects will be called 2, 4, and 6 or 7 days after this visit to ask how they are doing after starting this dose of study drug. We will leave them a message if we cannot reach them. If there are any problems, we will schedule them to come to the clinic within the next 2 days. The outpatient visit and hospital admission will repeat again. At the end of the second hospital admission, treatment on the study is over and subjects will go back to their original Parkinson's disease medications. The study will end with a follow up phone call or clinic visit 2 - 4 weeks after the final hospital admission. Subjects will fill out a daily diary that asks about their movement throughout the day for 3 days before they come to the Oregon Clinical and Translational Research Institute. Carbidopa is used for the treatment of Parkinson's disease with levodopa. This protocol is using a high dose of 450mg of carbidopa. This study is also using IV levodopa, which is a different route than is normally given. Finger tapping rates will be compared between high and low dose study drug use to see if one group has slower rates than the other.

NCT ID: NCT01399411 Completed - Asthma Clinical Trials

Agricultural Health Study Follow-up

Start date: July 5, 2011
Phase:
Study type: Observational

Background: - The Agricultural Health Study (AHS) is looking at the long-term health effects of farming exposures including pesticides, crops, and animals. The chronic health effects of exposure to pesticides are easier to study in farmers and their spouses. They know what chemicals they use and tend to live in the same place for most of their adult lives. AHS participants are expected to report any changes in their health. This includes any new medical conditions. Researchers want to follow up on these reports to confirm their accuracy. Objectives: - To follow up AHS participants who have self-reported that they have a new disease and confirm their diagnosis. Eligibility: - Current AHS participants. Design: - Researchers will confirm self-reported changes in medical conditions by contacting the AHS participant to ask for more information. - The AHS participant will give permission for researchers to contact their doctor to look at their medical records. They will also be asked to provide a cheek swab or saliva sample. - Diseases of interest are rheumatoid arthritis, lupus, and Sjogren s Syndrome. Other diseases will be followed up in the future. Other diseases will be followed up in the future.

NCT ID: NCT01397422 Completed - Parkinson's Disease Clinical Trials

Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)

EASED
Start date: July 2011
Phase: Phase 2/Phase 3
Study type: Interventional

This is a multi-center, randomized, double-blind, placebo-controlled, 4-arm parallel group study to evaluate the tolerability and efficacy of each of three dose levels of ADS-5102 oral capsules, an extended release formulation of amantadine, dosed once daily for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel pharmacokinetic profile of ADS-5102 is expected to achieve i) higher amantadine plasma concentrations during daytime hours when dyskinesia as well as motor and non-motor symptoms of PD are most problematic, ii) low amantadine plasma concentrations overnight, which may reduce the sleep disturbances and vivid dreams occasionally associated with amantadine, and iii) a reduced initial rate of rise in plasma concentration, which is expected to improve overall tolerability of amantadine.

NCT ID: NCT01391741 Completed - Parkinson´s Disease Clinical Trials

The Effect of High-Volume Walking With Visual Cues (VC) in Parkinson´s Disease (PD)

Start date: April 2008
Phase: Phase 3
Study type: Interventional

People with disease (PD) tend to walk with short steps, decreased velocity, and increased stride time variability. Short steps and increased variability are related to greater fall risk. In addition, concurrent performance of a cognitive task (dual-task (DT)) has marked effects on gait in people with PD which is considered to reflect an impaired automaticity of gait. Objective: To investigate short and long term effects of high-volume walking with visual spatial cues (VSC) on gait variables, automaticity, and functional mobility, in people with Parkinson´s Disease (PD), compared with walking without VSC.

NCT ID: NCT01382342 Completed - Parkinson's Disease Clinical Trials

The Effect of Rasagiline on Cognition in Parkinson's Disease

Start date: June 2011
Phase: Phase 4
Study type: Interventional

While Parkinson's disease has historically been defined in terms of its motor symptomatology, studies have shown that non-motor deficits form an important part of the syndrome. Cognitive deficits can occur even in the early stages of Parkinson's disease. These deficits are often subtle and do not rise to the level of impairment necessary for a diagnosis of dementia; however these deficits are discernable with neuropsychological testing and may produce subjective complaints of cognitive decline and mild functional difficulties in some patients. The traditional pharmacological interventions for Parkinson's disease have focused on controlling and alleviating motor symptoms with levodopa and dopamine agonists. However, these medications treat the symptoms of PD, but do not alter the course or progression of the underlying disorder. In contrast, rasagiline, an MAO-B inhibitor, has recently shown benefits consistent with a possible disease-modifying effect. Given the positive and intriguing findings seen with treatment with rasagiline, the investigators propose to study the effects of this medication on cognition in patients with mild to moderate stage Parkinson's disease. Hypotheses: 1. Rasagiline will improve cognitive function, as measured by performance on neuropsychological tests in PD patients who do not suffer from dementia. 2. Rasagiline will not negatively affect neuropsychiatric functioning.

NCT ID: NCT01378026 Not yet recruiting - Alzheimer Disease Clinical Trials

Study of the Role of G72 in Amyotrophic Lateral Sclerosis: Biomarker Discovery and Mechanism Investigation

Start date: January 2012
Phase: N/A
Study type: Observational

G72 gene is located on the common linkage locus in bipolar disorder and schizophrenia, and it encodes D-amino acid oxidase activator (DAOA). There are evidences that elucidated G72 and D-amino acid oxidase(DAO) together playing a critical role in the pathophysiology of schizophrenia. Recently, reports discovered missense mutations in the DAO (R199W DAO and R38H DAO) are associated with familial amyotrophic lateral sclerosis (FALS), and our preliminary data showed that the level of G72 autoantibody decreases in patients with ALS compared with normal control. Thus, we want to find out whether G72 plays a role in ALS and neurodegenerative diseases including Alzheimer disease and Parkinson's disease. First, we detect G72 protein and its autoantibody in sera of neurodegenerative diseases patients using ELISA and Western blotting, and the data are compared with normal control. We hypothesize the levels of G72 protein and its autoantibody in neurodegenerative diseases are less than those in normal control. Then, we extract genomic DNA of neurodegenerative diseases patients, and use polymerase chain reaction(PCR) to detect single nucleotide polymorphism (SNP) of G72. We aim to detect G72 missense SNP variants presented in ALS, AD and PD.

NCT ID: NCT01375413 Completed - Parkinson's Disease Clinical Trials

Dual Task Practice in Parkinson's Disease

Duality-PD
Start date: June 2011
Phase: Phase 3
Study type: Interventional

The ability to perform two or more tasks together is impaired in Parkinson's Disease (PD). Based on pilot work we hypothesize that dual tasking is amenable to training in PD and will not compromise safety. In the proposed study we will therefore collect high level evidence on whether 6 weeks of integrated dual task gait training is more effective than consecutive task practice. The investigators will use a randomized, single blind study design and conduct the same protocols in two academic centers (Katholieke Universiteit Leuven and Radboud Universiteit Nijmegen). The investigators intend to test an experimental condition which consists of focused dual task training in the home using a novel program of personalized cognitive tasks. The aim of dual task training is to teach motor-cognitive task integration and achieve optimal levels of automaticity and functionality. The control arm will receive gait practice and separate cognitive training of the same intensity, but offered consecutively. We will test the hypothesis that dual task training (integration) will have more pronounced effects on complex gait than consecutive task training. Sub-analysis will be conducted on patients with and without freezing of gait. The investigators expect that integrated dual task training may be less effective in patients with freezing, due to the increased fall risk and impaired cognitive profiles. Overall, this project will provide evidence to support future directions for motor learning and innovative rehabilitation targets.

NCT ID: NCT01366027 Completed - Stroke Clinical Trials

PRISM Registry: Pseudobulbar Affect Registry Series

Start date: May 2011
Phase: N/A
Study type: Observational

PBA is a neurologic condition that is estimated to impact over a million patients and their families in the United States. PBA occurs secondary to an otherwise unrelated neurologic disease or injury, and manifests as involuntary, frequent, and disruptive outbursts of crying and/or laughing. Progress has been made in better understanding this debilitating condition, but much more needs to be done. That's why a new PBA patient registry, PRISM (Pseudobulbar Affect RegIstry Series), has been initiated. The goal of PRISM is to establish the prevalence and quality of life (QOL) impact of PBA in patients with underlying neurologic conditions including - Alzheimer's disease - Amyotrophic lateral sclerosis - Multiple sclerosis - Parkinson's disease - Stroke - Traumatic brain injury Because this is an observational registry, it doesn't require you to intervene with any specific treatment or procedure. Your participation allows the PRISM registry to collect and analyze data from your site and also compare it to national numbers captured in the PRISM registry about PBA across all of the major at-risk neurologic populations.

NCT ID: NCT01364545 Recruiting - Parkinson's Disease Clinical Trials

Ketogenic Diets for Symptoms of Parkinson's Disease

Start date: May 2011
Phase: N/A
Study type: Interventional

Parkinson's disease is a progressive condition that harms nerve cells of the brain (neurodegeneration). Current treatments for Parkinson's disease (including levodopa and deep brain stimulation) improve certain symptoms but are not thought to improve the underlying neurodegenerative disease process (they are not a "cure"). The cause of Parkinson's disease is unknown. However, some evidence suggests that tiny structures in the investigators cells called "mitochondria" might be involved. Mitochondria are the powerhouses that produce fuel for the investigators cells. Failure of these 'powerhouses' to supply the energy needs of certain nerve cells might lead to Parkinson's disease. Preliminary evidence suggests that a food called 'ketones' might be able to enhance the function of mitochondria and improve Parkinson's disease symptoms and possibly even the neurodegenerative process. In this study, the investigators would like to investigate this possibility by giving patients with Parkinson's disease dietary supplements of 'ketone esters' in a drink. The investigators will then assess if this improves symptoms of Parkinson's disease. The study design is a prospective, double blinded, randomised, controlled trial.