View clinical trials related to Parkinson Disease.
Filter by:This is a single-site non-randomized open label pilot study. The investigators will use accelerometer-based instrumented gait analysis and computerized cognitive testing to study the interaction of motor and cognitive dysfunction in Parkinson disease dementia (PDD), and the effect of rivastigmine on motor and cognitive performance. All study participants will be tested for motor and cognitive performance at baseline (arm 1). A subgroup of study participants will then be treated with rivastigmine for 12 weeks (arm 2), and the effect of this treatment on gait measures and cognitive measures will be analyzed at the follow-up visit 12 weeks after the baseline visit. Specifically, we will determine which components of motor and cognitive impairment are associated with each other, and which components of the two domains respond to rivastigmine-mediated stimulation of cholinergic neurotransmission.
This longitudinal study aims to research cognitive and gait phenotypes of Parkinson's disease and Supranuclear Palsy as well as to provide markers to track diseases progression using a multi-modality approach based on 3D-gait analysis and MR Imaging. Specifically, this study want to identify cognitive pattern and gait-related cerebral diffusion/functional connectivity in PD and PSP patients and to verify their progression over a period of 18 months. In summary, the current protocol proposed to investigate the following issues: - to perform a multifactorial quantitative analysis of outcomes for PD and PSP compared to a control group in order to categorize cognitive and gait pattern in the group of patients and verify if the gait can be useful as discriminator for diagnosis. - to analyze whether diffusion and resting-state functional connectivity indices are correlated with clinical disease severity scores and motor scores and how they change over time (18 months later).
The aim of this study is to explore the potential of Ursodeoxycholic acid (UDCA) to slow down the progression of Parkinson's Disease (PD) in a randomised, double-blind, placebo-controlled, "proof of concept" study. The primary objective of the study will be to determine the safety and tolerability of this drug in patients with PD. Participants will be recruited form a cohort of patients who have been diagnosed with PD within the last 3 years and are potentially suitable for this study. There is strong evidence from previous research and the work carried out by other groups that UDCA rescues the function of the mitochondria (mitochondria are the "powerhouse" of the cell) in PD patient tissue and other models of PD. This suggests that UDCA may slow down the worsening of PD. UDCA has been in clinical use for the treatment of liver disease (primary biliary cholangitis) for over 30 years. The investigators therefore know that it is safe and well tolerated in patients with liver disease but the investigators don't know yet whether this is also the case in patients with PD. Furthermore, the dose used for patients with liver disease (15 mg/kg) is not high enough for UDCA to get into the brain. The investigators therefore need to double the dose to 30 mg/kg. This higher dose was also safe in clinical trials for liver disease, but is currently not used routinely in clinical practice.
Parkinson disease is the second most frequent neurodegenerative disease after Alzheimer disease and affect 1% of the population over 60 years. The treatment of PD is based on dopamine replacement therapies (DRT). Nausea is the most frequent adverse event whatever the drug, occurring in 30-40% of patients at the initiation of DRT. Domperidone, a dopamine D2 receptor antagonist with antiemetic properties, does not readily cross the blood-brain barrier, allowing its used in PD. Domperidone may prolong the duration of the QT interval in predisposed patients, and has been associated with proarrhythmia and arrhythmic deaths. Arrhythmias, sudden death and cardiac arrest were reported with high intravenous doses which has led to withdraw of the parenteral form of the drug in 1984. Two case control studies found an increased risk of sudden death associated with domperidone use. In these reports, the increased risk was depending on age, dose, and the use of domperidone in combination with CYP3A4 inhibitors. Following the discussion created by this alert, the PRAC of the EMA has issued recommendations restricting domperidone use to patients younger than 60 years at doses below 30 mg/day and for a short period (7 days). Because there is no alternative antiemetic drug to be used in PD, domperidone is commonly prescribed as a preventive therapy in most PD patients initiating DRT. In this population, usually older than 60 years, doses of 60 or 80 mg/day are commonly prescribed, for at least 2 months of the DRT escalating dose period or longer. A particular "niche" of domperidone misuse might be patients treated with continuous subcutaneous administration of apomorphine, a second line therapy in PD, inducing severe and prolonged nausea in almost all patients. Little is known about the use of domperidone in PD in France, but misuse of domperidone in PD patients is probably very high. Data collected from two French PD cohorts, COPARK and DIGPD, showed that 8-14% of PD patients were treated with domperidone. The aim of this proposal is to investigate the practices and beliefs of French neurologists regarding use and misuse of domperidone in PD, by a qualitative approach.
This study will examine the feasibility of an at-home cognitive training program that incorporates both memory training and online computerized cognitive training (CCT) software. Data will also be collected to determine if this program improves thinking and memory as well as everyday function. The hypothesis is that memory and cognitive training combined , compared to memory training alone or will lead to greater improvements in cognitive performance and daily function.
The purpose of the study is to learn about the impact of exercise on fatigue, anxiety, and depression in Parkinson's disease. It is well established that exercise improves the motor symptoms of Parkinson's disease. However, it is not clear which types of exercise are most beneficial for specific non-motor symptoms.
Phase I study to assess the safety, tolerability and pharmacokinetics of single and multiple doses of KW-6356 in healthy volunteers
Background: Current guidelines recommend that every person with Parkinson's disease (PD) should have access to Parkinson's Disease Nurse Specialist (PDNS) care. Thus, hospitals increasingly offer PDNS care to their patients with PD. However, there is currently little scientific evidence on the cost-effectiveness of PDNS care. Consequently, many hospitals lack the nursing capacity to offer PDNS care to all patients, which creates unequal access to care and possibly avoidable disability and costs. Objective: The investigators aim to study the (cost-)effectiveness of specialized nursing care provided by a PDNS as compared to no PDNS care for people with PD in all disease stages. To gain more insight into the used interventions and their effects, a subgroup analysis will be performed based on disease duration (diagnosis made <5, 5-10, or >10 years ago). Methods: The investigators will perform an 18-month, single-blind, randomized controlled clinical trial in eight community hospitals in the Netherlands. A total of 240 people with idiopathic PD that have not been treated by a PDNS over the past two years will be included, independent of disease severity or duration. In each hospital, 30 patients will randomly be allocated in a 1:1 ratio to either PDNS care according to the Dutch Guideline on PDNS care or no nursing intervention (continuing usual care). For the allocation of participants, a computer-generated list of random numbers will be used. The co-primary outcome measures are Quality of Life (QoL) and motor symptoms. Secondary outcomes include PD symptoms, mobility, non-motor symptoms, health-related quality of life, experienced quality of care, self-management, medication adherence, caregiver quality of life, coping skills and caregiver burden. Data will be collected after 12 months and 18 months. A healthcare utilization and productivity loss questionnaire will be completed every 3 months by both the patient and the caregiver. Hypothesis: The investigators hypothesize that, by offering more patients access to PDNS care, QoL will increase with equal healthcare costs. Increasing direct medical costs (for nurse staffing) will be offset by a reduced number of consultations with the general practitioner and neurologist. If these outcomes are reached, wide implementation of PDNS care is needed.
The kinesiophobia; defined as irrational fear of movement, which may occur after painful injury and reduce physical activity. It develops the idea that movement in individuals will cause re-injury and cause additional pain to existing pain. Studies have shown that this situation leads to a decrease in physical fitness, avoidance of activity, decrease in quality of life and even depression in the long term. It is known that functional problems such as balance problems and decrease in physical activity level occur in patients with Parkinson's disease. However, in the literature, there is no study investigating the presence of kinesiophobia in patients with Parkinson's disease. Therefore, the aims of our study were to 1) determine the presence / absence of kinesiophobia in patients with Parkinson's disease 2) determine the relationship between kinesiophobia and falling, balance, physical activity level in the presence of kinesiophobia.
This is a prospective interventional clinical study whose main objective is to determine the impact of oral hygiene guidance on the oral health status of patients with Parkinson disease