A Phase 2 Study and Open-Label Extension of NEU-411 in Companion Diagnostic-Positive Participants With Early Parkinson's Disease
NCT06680830 · Parkinson Disease, Parkinson, Idiopathic Parkinson Disease
RecruitingThe goal of this Phase 2 clinical trial is to investigate the efficacy and safety of NEU-411 in men and women aged 40-80 years with early Parkinson's Disease (PD) who have predicted elevations in the activity of the "leucine-rich repeat kinase 2" ("LRRK2" for short) pathway based on their genetic profile. A DNA test will be used to identify the "LRRK2-driven" population with predicted elevation in the LRRK2 pathway.
PhasePhase 2
TypeInterventional
Age40 Years – 80 Years
WhereSun City, Arizona, United States + 69 more
SponsorNeuron23 Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Moderate Versus High Volume Light-Moderate Intensity Exercise for People With Moderate Parkinson's Disease
NCT06088355 · Parkinson Disease, Movement Disorders, Neurodegeneration
RecruitingVeterans with mid to later stage Parkinson's disease (PD) may not be able to work out as hard as they need to, to prevent brain cell loss. Maybe they could work out longer and more frequently to make up for this during their good times and good weeks and then rest during the bad weeks. The investigators will compare how effective working out a lot one week per month with a break of three weeks is to continuously exercising weekly with no breaks in people with mid stage PD. The investigators will look at how fast participants walk per minute, whether they become more physically active, the biochemicals in their blood, and at how stiff their blood vessels are before and after the exercise.
PhaseNA
TypeInterventional
Age40 Years
WhereDecatur, Georgia, United States
SponsorVA Office of Research and Development
▾Tap for detailsClick for full details — eligibility, all locations, contacts PPMI Clinical - Establishing a Deeply Phenotyped PD Cohort
NCT04477785 · Parkinson Disease
RecruitingThe Parkinson Progression Marker Initiative (PPMI) is a longitudinal, observational, multi-center natural history study to assess progression of clinical features, digital outcomes, and imaging, biologic and genetic markers of Parkinson's disease (PD) progression in study participants with manifest PD, prodromal PD, and healthy controls. The overall goal of PPMI is to identify markers of disease progression for use in clinical trials of therapies to reduce progression of PD disability.
Phase—
TypeObservational
Age30 Years
WhereBirmingham, Alabama, United States + 49 more
SponsorMichael J. Fox Foundation for Parkinson's Research
▾Tap for detailsClick for full details — eligibility, all locations, contacts RE104 Safety and Efficacy Study in Adjustment Disorder in Cancer and Other Medical Illnesses
NCT07002034 · Adjustment Disorder
RecruitingThe purpose of this study is to determine if treatment with a single dose of RE104 for Injection reduces depressive symptoms or depressive symptoms mixed with anxiety symptoms in participants with Adjustment Disorder due to cancer or other illnesses such as Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Parkinson's Disease (PD) or Idiopathic Pulmonary Fibrosis (IPF) as compared to active-placebo.
PhasePhase 2
TypeInterventional
Age18 Years – 80 Years
WhereBirmingham, Alabama, United States + 24 more
SponsorReunion Neuroscience Inc
▾Tap for detailsClick for full details — eligibility, all locations, contacts Safety and Efficacy Study of Investigational Agents as Monotherapy or in Combination With Pembrolizumab (MK-3475) for the Treatment of Extensive-Stage Small Cell Lung Cancer (ES-SCLC) in Need of Second-Line Therapy (MK-3475-B98/KEYNOTE-B98)
NCT04938817 · Small Cell Lung Carcinoma
RecruitingThis study is a rolling arm study of investigational agents as monotherapy or in combination with pembrolizumab in participants with anti-programmed cell death 1 (PD-1)/ programmed cell death ligand 1 (PD-L1) refractory ES-SCLC in need of second-line treatment. This study will have 2 parts: an initial safety lead-in to determine safety and tolerability for experimental combinations of investigational agents without an established recommended phase 2 dose (RP2D) followed by an efficacy evaluation. Investigational agents will initiate directly in or be added to the efficacy evaluation after an initial evaluation of safety and tolerability of the investigational agent has been completed in a separate study or in the safety lead-in of this study. If an RP2D for a combination being evaluated in the safety lead-in is established from another study, then the efficacy evaluation may begin at the determined RP2D. There will be no hypothesis testing in this study.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereGilbert, Arizona, United States + 47 more
SponsorMerck Sharp & Dohme LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts North American Prodromal Synucleinopathy Consortium Stage 2
NCT05826457 · REM Sleep Behavior Disorder, Parkinson Disease, Lewy Body Dementia
RecruitingThis study will enroll participants with idiopathic REM sleep behavior disorder (RBD) and healthy controls for the purpose of preparing for a clinical trial of neuroprotective treatments against synucleinopathies.
Phase—
TypeObservational
Age18 Years
WhereLos Angeles, California, United States + 8 more
SponsorWashington University School of Medicine
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Buntanetap in Participants With PD
NCT07284784 · Parkinson's Disease (PD), Deep Brain Stimulation
RecruitingThis study will examine the long-term safety of buntanetap in participants with PD. This will be a 36-month open-label safety study. This study will be conducted with two cohorts. Cohort 1 will enroll via invitation only for PD participants who have previously participated in buntanetap clinical trials. Cohort 2 will be for PD participants who are receiving deep brain stimulation (DBS) treatment. Qualified participants will receive buntanetap 30mg QD after a screening period of up to 42 days.
PhasePhase 2 / Phase 3
TypeInterventional
Age40 Years – 85 Years
WhereBirmingham, Alabama, United States + 26 more
SponsorAnnovis Bio Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD)
NCT06285643 · Parkinson Disease
RecruitingThe objective of this randomized, surgically controlled, double-blinded, Phase 2 study is to evaluate the safety and efficacy of AAV2-GDNF delivered to the putamen in subjects with moderate Parkinson's Disease.
PhasePhase 2
TypeInterventional
Age45 Years – 75 Years
WhereIrvine, California, United States + 38 more
SponsorAskBio Inc
▾Tap for detailsClick for full details — eligibility, all locations, contacts The Parkinson's Genetic Research Study
NCT01558479 · Parkinson's Disease
RecruitingThe Parkinson's Genetic Research Study (PaGeR), headed by Dr. Cyrus Zabetian, is searching for genes that increase the risk of developing Parkinson's disease (PD) and related disorders. The study is a joint effort by neurologists and researchers across the United States and is sponsored by the National Institutes of Health. The coordinating center for PaGeR is located at the University of Washington and the VA Puget Sound Health Care System in Seattle.
Phase—
TypeObservational
Age18 Years
WhereAtlanta, Georgia, United States + 4 more
SponsorUniversity of Washington
▾Tap for detailsClick for full details — eligibility, all locations, contacts Parkinson's Foundation PD GENEration Genetic Registry
NCT04994015 · Parkinson's Disease
RecruitingDevelopment of a central repository for PD-related genomic data for future research.
Phase—
TypeObservational
Age18 Years
WhereBirmingham, Alabama, United States + 55 more
SponsorParkinson's Foundation
▾Tap for detailsClick for full details — eligibility, all locations, contacts Cortical Electrophysiology of Response Inhibition in Parkinson's Disease
NCT06234995 · Parkinson Disease
RecruitingPatients with Parkinson's Disease will be studied before, during, and after a deep brain stimulation implantation procedure to see if the stimulation location and the size of the electrical field produced by subthalamic nucleus (STN) DBS determine the degree to which DBS engages circuits that involve prefrontal cortex executive functions, and therefore have a direct impact on the patient's ability to inhibit actions.
PhasePhase 4
TypeInterventional
Age45 Years – 75 Years
WhereAtlanta, Georgia, United States + 1 more
SponsorEmory University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study in Parkinson Disease of Exercise
NCT04284436 · Parkinson Disease
RecruitingThis study is a Phase 3 multi-site, randomized, evaluator-masked, study of endurance treadmill exercise on changes in the Movement Disorder Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part III score at 12 months among persons with early stage Parkinson disease. 370 participants will be randomly assigned to 2 groups: 1)60-65% HRmax or 2)80-85% HRmax 4 times per week. The primary objective is to test whether the progression of the signs of Parkinson's disease is attenuated at 12 months in among persons who have not initiated medication for Parkinson Disease (PD) when they perform high-intensity endurance treadmill exercise.
PhaseNA
TypeInterventional
Age40 Years – 80 Years
WhereBirmingham, Alabama, United States + 24 more
SponsorNorthwestern University
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