Methodological considerations supporting a time-to-event primary endpoint in the PADOVA study in early-stage Parkinson’s disease participants on stable symptomatic treatment
Objective: To provide the methodological rationale for using a time-to-event (TTE) primary endpoint in the PADOVA study. Background: The use of symptomatic medications represents a…Mathematical and Computational Modeling Prototype to Understand the Evolution of Parkinson’s disease using Four Differential Equations
Objective: Apply four differential equations to generate projections considering the effect of dopamine on Parkinson’s disease progression, leading to the development of an initial prototype…Quality of Life Improvements in Parkinson’s Disease for Those Treated with Photobiomodulation Plus Exercise: A Sham-Controlled Study
Objective: To assess whether exercise alone, or exercise combined with photobiomodulation (PBM) can improve the health-related quality of life (QoL) for people with Parkinson’s disease…CAP-003, a CNS-targeted IV-delivered AAV Gene Therapy Developed for Patients with Parkinson’s Disease associated with GBA1 Mutations
Objective: CAP-003 is a next-generation gene therapy candidate, comprising a novel brain-tropic capsid paired with hGBA1 cargo, that was developed for administration as a single…A Phase 2 Study of Risvodetinib in Untreated Parkinson’s Disease
Objective: Risvodetinib was evaluated in a randomized, double-blind, placebo controlled Phase 2 trial at three doses to determine the safety and tolerability in patients with…Effect of Allogeneic Bone-Marrow Derived Mesenchymal Stem Cell Therapy on Quality of Life in Patients with Parkinson’s Disease
Objective: To assess the impact of intravenous (IV) allogeneic bone marrow-derived mesenchymal stem cell (allo-hMSC) infusions on the quality of life (QoL) of patients with…A Systematic Site Selection Approach to Ensure Efficient and Diverse Participant Recruitment to a Large-Scale Multi-Arm, Multi-Stage Platform Trial for Parkinson’s
Objective: To select up to 40 delivery sites to successfully recruit and retain a participant population representative of people with Parkinson’s disease (PwP) in the…EJS ACT-PD: An Ongoing Initiative to Support Innovation and Sustainability of a Multi-Arm, Multi-Stage Platform Trial for Parkinson’s Disease
Objective: To provide continued consortium expertise to provide ongoing innovation and long-term sustainability in a multi-arm, multi-stage (MAMS) disease modification trial for Parkinson’s disease (PD).…Lithium Therapy Associated with Reductions in Serum Neurofilament Light Chain (NfL) in Parkinson’s Disease.
Objective: To assess the effects of lithium aspartate and lithium carbonate therapy for 24 weeks on serum NfL in Parkinson’s disease (PD). Background: Lithium has…First-In-Human Single and Multiple Ascending Dose Trial Design of LY3962681, a Novel Intrathecally Delivered siRNA Targeting α-synuclein mRNA for the Treatment of Patients with Parkinson’s Disease
Objective: Development of a Phase 1 clinical trial evaluating LY3962681, a novel, intrathecally delivered siRNA directly targeting α-synucleinmRNA (SNCA) to reduce α-synuclein protein (ASYN), for the treatment of…
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