Blood Flow Restriction for Optimizing Balance in Parkinson's Disease
NCT06508801 · Parkinson's Disease and Parkinsonism
RecruitingThis study is being done to understand how reducing blood flow (BRT) during balance-challenging strengthening exercises (instability resistance training, or IRT) can help improve symptoms of Parkinson's disease.
PhaseNA
TypeInterventional
Age40 Years – 85 Years
WhereSan Antonio, Texas, United States
SponsorThe University of Texas Health Science Center at San Antonio
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)
NCT06312176 · Breast Neoplasms
RecruitingThe purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally advanced, or metastatic, breast cancer. The primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab tirumotecan plus pembrolizumab are superior to TPC with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) in all participants.
PhasePhase 3
TypeInterventional
Age18 Years
WhereChandler, Arizona, United States + 257 more
SponsorMerck Sharp & Dohme LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis
NCT04373317 · Parkinson's Disease Psychosis
RecruitingPatients with Parkinson's disease (PD) sometimes experience symptoms affecting their movement, such as slowness, tremor, stiffness, and balance or walking problems. Many patients also have other symptoms not related to movement, called non-motor symptoms, which may affect one's mood or emotions, memory or thinking, or cause one to see or hear things that aren't real (hallucinations) or believe things that aren't true (delusions). Hallucinations or delusions, together called psychosis, occur in up to 60% of PD patients at some point in time. Parkinson's disease psychosis can sometimes be associated with decreased quality of life, increased nursing home placement, increased rate of death, and greater caregiver burden. There are approximately 50,000 Veterans with Parkinson's disease receiving care in the VA, and up to 30,000 (60%) of them will experience psychosis at some point in time. Quetiapine is an antipsychotic drug approved by the Food and Drug Administration (FDA) that is the most commonly used medication to treat PD psychosis, but more studies are needed to determine if it works for this condition and is also well tolerated and safe. Pimavanserin is a newer antipsychotic drug approved by the Food and Drug Administration (FDA) specifically to treat PD psychosis, but more studies are needed to determine if it works and its safety. The purpose of this research is to gather additional information on the safety and effectiveness of both Quetiapine and Pimavanserin. By doing this study, the investigators hope to learn which of these medications is the most effective course of treatment for people with PD psychosis. Enrollment is open to Veterans nationwide, see your VA provider about the possibility of being referred to one of the study's Hub sites. This can be done through contact from your provider to the study's NSC (Tamara Boney at 267-303-9829).
PhasePhase 4
TypeInterventional
Age40 Years
WhereTucson, Arizona, United States + 23 more
SponsorVA Office of Research and Development
▾Tap for detailsClick for full details — eligibility, all locations, contacts Comparing Antipsychotic Medications in LBD Over Time
NCT05590637 · Parkinson's Disease Psychosis, Dementia With Lewy Bodies
RecruitingThe primary objective of this study is to determine whether treatment with pimavanserin or quetiapine is associated with a greater improvement in psychosis when used in a routine clinical setting to treat hallucinations and/or delusions due to Parkinson's disease (PD) or dementia with Lewy bodies (DLB) - collectively referred to as Lewy body disease (LBD).
PhasePhase 4
TypeInterventional
AgeAny
WhereSan Antonio, Texas, United States + 1 more
SponsorThe University of Texas Health Science Center at San Antonio
▾Tap for detailsClick for full details — eligibility, all locations, contacts Real-World Study of ABBV-951 Subcutaneous Infusion to Assess Change in Disease Activity in Adult Participants With Parkinson's Disease
NCT06107426 · Parkinson's Disease (PD)
RecruitingParkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. The purpose of this study is to evaluate how effective ABBV-951 is in treating adult participants with advanced PD in real world setting. ABBV-951 (foslevodopa/foscarbidopa) is an approved drug for the treatment of Parkinson's Disease. The main ROSSINI study will have approximately 450 adult participants with PD (300 participants new to ABBV-951, up to 150 participants transitioning from open-label extension study) will be enrolled across approximately 60 sites. Decision to treat with ABBV-951 (or continue the treatment in Cohort B) will be made by the doctor prior to any decision to approach the participant to participate in this study. There will be a sub-study that will enroll 40 naïve participants who initiated Foslevodopa/Foscarbidopa treatment for the first time (Cohort A of the ROSSINI parent study only) from 6 to 15 centers in the United States, Germany and Spain. All participants will receive subcutaneous infusion of ABBV-951 for approximately 3 years. Participants will attend regular clinic visits during the course of the study. The effect of the treatment will be checked by medical assessments, and completing questionnaires.
Phase—
TypeObservational
Age18 Years
WhereBirmingham, Alabama, United States + 67 more
SponsorAbbVie
▾Tap for detailsClick for full details — eligibility, all locations, contacts Endurance Exercise & Virtual Reality for Optimizing Cortical Excitability and Neuroplasticity in PD
NCT06133283 · Parkinson Disease
RecruitingThis study aims to determine the effects of aerobic exercise as a primer to add-on virtual reality (VR)-based rehabilitation on balance, postural control and neuroplasticity (ability of brain to adapt in structure and function) in individuals with Parkinson's disease (PD). This study will utilize two groups - one group will receive the exercise and VR, while the other group will receive stretching exercise and VR over eight weeks. The study team will administer outcomes at baseline, post-intervention (8 weeks) and follow-up (6 weeks after post-assessment).
PhaseNA
TypeInterventional
Age18 Years – 85 Years
WhereSan Antonio, Texas, United States
SponsorThe University of Texas Health Science Center at San Antonio
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)
NCT06966700 · Breast Neoplasms, Triple Negative Breast Neoplasms, HR Low-Positive/HER2-Negative Breast Neoplasms
RecruitingResearchers are looking for new ways to treat types of breast cancer that are both: * High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment * Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone. Sacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread. The main goals of this study are to learn if people who receive sac-TMT, pembrolizumab, and chemotherapy: * Have fewer cancer cells found in the tumors and lymph nodes removed during surgery compared to those who receive only pembrolizumab and chemotherapy * Live longer without the cancer growing, spreading, or coming back compared to people who receive only pembrolizumab with chemotherapy
PhasePhase 3
TypeInterventional
Age18 Years
WhereGilbert, Arizona, United States + 267 more
SponsorMerck Sharp & Dohme LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Compare Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) Versus Pembrolizumab Alone as Treatment in Participants With Mismatch Repair Proficient Endometrial Cancer (MK-2870-033/TroFuse-033/GOG-3119/ENGOT-en29)
NCT06952504 · Endometrial Cancer
RecruitingResearchers are looking for new ways to treat people with proficient mismatch repair (pMMR) endometrial cancer (EC) that is advanced or recurrent. * EC is a type of cancer that starts in the tissues inside the uterus (womb) * pMMR indicates that certain normal proteins are present in the cancer cells * Advanced means the cancer has spread locally or to other parts of the body (metastatic) and cannot be removed with surgery * Recurrent means the cancer came back after surgery Sacituzumab tirumotecan (also known as sac-TMT) and pembrolizumab are the study medicines. Sac-TMT is an antibody drug conjugate (ADC). An ADC attaches to specific targets on cancer cells and delivers treatment to destroy those cells. The goal of this study is to learn if people who receive sac-TMT with pembrolizumab live longer and without the cancer getting worse compared to people who receive pembrolizumab alone.
PhasePhase 3
TypeInterventional
Age18 Years
WhereMobile, Alabama, United States + 242 more
SponsorMerck Sharp & Dohme LLC
▾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 A Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) as Monotherapy and in Combination With Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011)
NCT06841354 · Triple Negative Breast Neoplasms
RecruitingResearchers want to know if sacituzumab tirumotecan given alone or with pembrolizumab can treat triple negative breast cancer (TNBC). The main goal of this study is to learn if people treated with sacituzumab tirumotecan alone or with pembrolizumab live longer overall or without the cancer growing or spreading compared to people treated with chemotherapy.
PhasePhase 3
TypeInterventional
Age18 Years
WhereMobile, Alabama, United States + 254 more
SponsorMerck Sharp & Dohme LLC
▾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
▾Tap for detailsClick for full details — eligibility, all locations, contacts