Evaluation of NT-0796 in Healthy Volunteers and Individuals with Parkinson's Disease

The primary objective of the study is to evaluate the effects of **NT-0796** in individuals diagnosed with **Parkinson's Disease**. This investigation is clinically relevant as it aims to assess the potential therapeutic benefits and safety profile of NT-0796, which could contribute to the management and treatment of Parkinson's Disease, a progressive neurodegenerative disorder characterized by motor and non-motor symptoms. The study also includes healthy volunteers to provide a comparative analysis of the drug's effects, which is crucial for understanding its impact on the target population.

The clinical trial focuses on individuals diagnosed with **Parkinson's Disease**. The study population includes both male and female participants, encompassing a broad age range from young adults to older adults. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants involved in the study. Participants were selected without specific emphasis on lifestyle considerations such as diet, physical activity, or habits. The trial does not specify any key inclusion or exclusion criteria, as this information was not disclosed by the sponsor.

The clinical trial is designed to evaluate the effects of a novel treatment in individuals diagnosed with **Parkinson's Disease**. This study is structured as a **randomized, double-blind, controlled** trial, ensuring that neither the participants nor the researchers know who is receiving the treatment or placebo, thereby minimizing bias. The trial is categorized under Phase 3, indicating that it is in the later stages of clinical testing, focusing on the efficacy and monitoring of adverse reactions in a larger patient population. The estimated recruitment start date was April 4, 2023, with the trial expected to conclude by July 17, 2023, marking a total duration of approximately three and a half months.

Participants will undergo a series of study visits, beginning with an inclusion visit, also known as the screening visit, where eligibility criteria are assessed. This initial visit is crucial for determining participant suitability based on predefined inclusion and exclusion criteria. Following successful screening, participants will be enrolled in the study and randomly assigned to either the treatment or control group. Throughout the trial, several follow-up visits will be scheduled to monitor the participants' health, assess the treatment's efficacy, and record any adverse events. These visits are essential for collecting data on the primary and secondary endpoints of the study.

The end-of-study visit marks the final assessment, where comprehensive evaluations are conducted to gather concluding data on the treatment's impact. The expected length of participant involvement spans the entire trial duration, from the initial screening to the end-of-study visit. However, certain conditions may necessitate early termination from the study, such as the occurrence of significant adverse events, withdrawal of consent, or non-compliance with study protocols. These measures ensure the safety and integrity of the trial while maintaining adherence to ethical standards.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or frequency of administration. As such, no detailed description of the experimental treatment can be provided based on the available data.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Consequently, no description of these elements can be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be elaborated upon in this context.

The clinical trial is in Phase 3, indicating it is designed to assess the efficacy and safety of the investigational treatment in a larger patient population. The trial is scheduled to begin recruitment on April 4, 2023, with an estimated end date of July 17, 2023. The efficacy of the treatment will be evaluated through specific parameters or endpoints, although these are not detailed in the provided data. The trial will follow a structured protocol to ensure the collection and analysis of efficacy data is consistent and reliable. The methods and schedule for measuring these parameters, as well as any tools or instruments used, are not specified in the available information. The trial's design and execution will adhere to regulatory standards to ensure the validity and integrity of the efficacy assessments.