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REM Sleep Behavior Disorder clinical trials

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NCT ID: NCT03047408 Not yet recruiting - Parkinson's Disease Clinical Trials

Evolution of RBD in PD

Start date: February 2017
Phase: N/A
Study type: Interventional

About 60% of Parkinson's Disease (PD) patients have REM sleep Behavior Disorder (RBD), a parasomnia characterized by partial or complete loss of REM sleep muscle atonia and dream-enacting behaviors, usually associated to vivid dreams. The REM Sleep without atonia is the polysomnographic hallmark of RBD, and its quantification is necessary for the diagnosis. RBD in PD is believed to be a marker of a more widespread degenerative process and a marker of malignant phenotype. Therefore, PD patients with RBD (PD-RBD) are more severely impaired in both motor and non-motor domains, compared to those without RBD, with an increased risk of dementia. However, little is know about the relationship between the evolution of RBD, clinic and video-polysomnographic, and the progression of PD. Besides, an improvement of RBD symptoms is anecdotally reported in PD patients over time. Longitudinal evaluation of RBD in PD, assessed by questionnaires, led to controversial results, but so far, no longitudinal vPSG study has been performed in PD-RBD population. Thus, the main objective of this study is to longitudinally evaluate clinical and video-polysomnographic features of RBD, including measure of REM Sleep without atonia, in patients with PD-RBD, after three years from the diagnosis of RBD, in order to ascertain whether RBD features remain stable over time. The possible remission of RBD with the progression of PD would question indeed its reliability as prognostic bio-marker.

NCT ID: NCT02984137 Completed - Parkinson Disease Clinical Trials

Prospective Neuroimaging Investigation of Idiopathic REM Sleep Behavior Disorder

Start date: June 2013
Phase: N/A
Study type: Interventional

This is a prospective cohort study to evaluate degenerative changes in the brain by performing functional imaging analysis in patients with RBD and its correlations with clinical symptoms and dopaminergic degeneration. This study also evaluates cognitive changes with functional imaging measures and olfactory and other premotor symptoms of Lewy body disease. This study also collects gene extracts and sera to develop a biomarker for early detection of neurodegeneration.

NCT ID: NCT02871427 Terminated - Clinical trials for Dementia With Lewy Bodies

Open-label Study of Nelotanserin in Lewy Body Dementia With Visual Hallucinations or REM Sleep Behavior Disorder

Start date: October 20, 2016
Phase: Phase 2
Study type: Interventional

This study seeks to evaluate the long-term safety and effectiveness of nelotanserin for the treatment of visual hallucinations (VHs) and Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD) in subjects with Lewy body dementia (LBD).

NCT ID: NCT02836743 Recruiting - Clinical trials for REM Sleep Behavior Disorder

Effect of Slow-release Melatonin (Circadin®) Therapy on Idiopathic RBD: a Pilot Study

Start date: January 2016
Phase: Phase 4
Study type: Interventional

To evaluate effect of slow-release melatonin (Circadin) on REM sleep behavior disorder.

NCT ID: NCT02824341 Completed - Parkinson's Disease Clinical Trials

Exploration of the Reward System by Functional MRI in Parkinson's Disease Patients With and Without REM Sleep Behavior Disorder

MP-TCSP-IRMf
Start date: October 2015
Phase: N/A
Study type: Interventional

Up to 60% of Parkinson's Disease (PD) patients suffer from REM sleep behavior disorder (RBD), a parasomnia. This disorder is thought to be related to a dysfunction of limbic system and brainstem. Impulse control disorders (ICD) are found in about 14% of PD patients taking dopaminergic drugs. These disorders are thought to be related to a dysfunction of meso-cortico-limbic pathways which belong to the so-called "reward system". A strong link was found between these two disorders and therefore the investigators believe that RBD is associated with impaired reward system. The main objective of this study is to evaluate differences in brain activation between PD patients with and without RBD. The investigators hypothesize that PD patients with RBD have a more severe dysfunction of the reward system (hypoactivation of the meso-cortico-limbic pathway) than patients without RBD, explaining their susceptibility to ICD when exposed to high doses of dopaminergic treatment.

NCT ID: NCT02789592 Not yet recruiting - Parkinson Disease Clinical Trials

Efficacy and Safety of Melatonin PR and Clonazepam in Patients With REM Sleep Behavior Disorder in Parkinson Disease

Start date: July 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether melatonin prolonged-release (PR) and clonazepam are effective and safe in the treatment of rapid eye movement behavior disorder (RBD) of patients with Parkinson's disease (PD).

NCT ID: NCT02708186 Completed - Clinical trials for Dementia With Lewy Bodies

Study Evaluating Nelotanserin for Treatment of REM Sleep Behavior Disorder in Subjects With Dementia (DLB or PDD)

Start date: March 2016
Phase: Phase 2
Study type: Interventional

This study seeks to evaluate the safety and efficacy of Nelotanserin for the treatment of Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD) in subjects with dementia with Lewy bodies (DLB) or Parkinson's disease dementia (PDD).

NCT ID: NCT02640339 Completed - Parkinson Disease Clinical Trials

Retinal Abnormalities as Biomarker of Disease Progression and Early Diagnosis of Parkinson Disease

Start date: February 2016
Phase:
Study type: Observational

- To determine whether retinal abnormalities, as measured by high definition optical coherence tomography (HD-OCT) and visual electrophysiology techniques can be used as a clinical biomarker to monitor disease progression overtime in patients with Parkinson disease. - To establish whether these measures can be used to identify patients with PD in the premotor phase. - To define the rate of progression of retinal abnormalities in PD (both in the motor and premotor stages) for potential use as a clinical outcome measure

NCT ID: NCT02554331 Terminated - Parkinson's Disease Clinical Trials

Gait and REM Sleep Behavior Disorder

RBD-M2H
Start date: April 17, 2014
Phase: N/A
Study type: Interventional

Many people with idiopathic rapid eye movement (REM) sleep behavior disorder (RBD) have an underlying synucleinopathy, the most common of which are Parkinson's disease (PD) and Lewy body disease. Identifying additional abnormal clinical features may help in identifying those at greater risk of evolving to a more severe syndrome. Because gait disorders are common in the synucleinopathies, early abnormalities in gait in those with RBD could help in identifying those at increased risk of developing overt parkinsonism and/or cognitive impairment. The investigators aim to identify subtle gait abnormalities in idiopathic RBD and to identify sensitive and early biomarkers: 1. to detect subtle gait disorders in pre-symptomatic stage of synucleinopathy and 2. to track their evolution in the parallel with the disease progression. Main objective: In comparison with age and gender matched-controls, to identify in patients with RBD a larger reduction of gait velocity (and other abnormalities of spatio-temporal characteristics of gait) between a single (gait) and a dual-task (gait+cognitive task). Secondary objective: 1. In comparison with age and gender matched-PD patients, to identify in patients with RBD a smaller reduction of gait velocity (and other abnormalities of spatio-temporal characteristics of gait) between a single (gait) and a dual-task (gait+cognitive task). 2. In patients with RBD to identify correlations between the spatio-temporal characteristics modifications of gait between a single (gait) and a dual-task (gait+cognitive task) and the percentage of REM without atonia - the dopamine transporter (DAT) density using FP-CIT single-photon emission computed tomography; the reduction of the olfactory discrimination and thresholds. 3. In patients with RBD to track the spatio-temporal characteristics evolution of gait over time (every 6 months for 2 years)

NCT ID: NCT02312908 Completed - Clinical trials for REM Sleep Behavior Disorder

Effect of Clonazepam on REM Sleep Behavior Disorder in Patients With Parkinsonism

Start date: March 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether clonazepam is effective and safe in the treatment of rapid eye movement behavior disorder (RBD) of patients with Parkinson's disease (PD).