Comparative Evaluation of Cardiac [18F]-MFBG PET and [123I]-MIBG SPECT in Differentiating Parkinson's Disease, Multiple System Atrophy, Dementia with Lewy Bodies, and Alzheimer's Disease

The primary objective of this study is to conduct a **prospective head-to-head comparison** of cardiac [18F]-MFBG PET versus [123I]-MIBG SPECT imaging techniques. This comparison aims to differentiate between **Parkinson's disease** and **multiple system atrophy**, as well as between **dementia with Lewy bodies** and **Alzheimer's disease**. The clinical relevance of this study lies in its potential to improve diagnostic accuracy for these neurodegenerative disorders, which can lead to more targeted and effective treatment strategies.

The clinical trial involves participants diagnosed with **Parkinson's disease**, **Alzheimer's Disease**, **Multiple systems atrophy - parkinsonian variant**, and **Dementia with Lewy Bodies**. The study population includes both male and female subjects, with an age range corresponding to categories 3 and 4, indicating a focus on adult and elderly populations. The trial also includes a vulnerable population, although specific details regarding the total number of participants have not been provided by the sponsor. The selection criteria for the trial population, as well as any relevant lifestyle considerations such as diet, physical activity, or habits, have not been disclosed. Key inclusion or exclusion criteria are not specified, and the sponsor has not provided information on these aspects.

The clinical trial is designed to evaluate the efficacy of cardiac **[18F]-MFBG PET** compared to **[123I]-MIBG SPECT** in differentiating between **Parkinson's disease** and **multiple system atrophy**, as well as between **dementia with Lewy bodies** and **Alzheimer's disease**. This study is structured as a prospective, randomized, double-blind, controlled trial. The estimated duration of the trial spans from November 1, 2023, to December 31, 2026. Participants will be involved in the study for a period that aligns with the trial's timeline, subject to their continued eligibility and adherence to the study protocol.

The sequence of study visits begins with an inclusion visit, which serves as a screening to determine participant eligibility based on predefined criteria. Following successful inclusion, participants will undergo a series of follow-up visits at specified intervals to monitor their condition and gather necessary data. These visits are crucial for assessing the primary and secondary endpoints of the trial. The end-of-study visit marks the conclusion of a participant's involvement, where final assessments are conducted to evaluate the outcomes of the intervention.

Participants may be subject to early termination from the study if they experience adverse events, fail to comply with the study protocol, or withdraw consent. The trial's design ensures that all procedures are conducted in accordance with ethical standards and regulatory requirements, maintaining the integrity and scientific validity of the research. The study aims to provide valuable insights into the diagnostic capabilities of the imaging techniques under investigation, potentially influencing future clinical practices in the management of these neurological conditions.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its **pharmaceutical form**, dosage, route, or frequency of administration. Additionally, there is no information available about any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, that may be used in the study. Furthermore, the documentation lacks details on drug administration, dosing schedules, and participant compliance monitoring. As such, no further description of the treatments used in this clinical trial can be provided based on the available data.

The clinical trial is scheduled to commence recruitment on November 1, 2023, with an estimated completion date of December 31, 2026. The trial is categorized under phase 10, indicating an advanced stage of clinical research. Efficacy assessments will be conducted throughout the trial period, although specific parameters or endpoints for evaluating efficacy are not detailed in the provided data. The methods and schedule for measuring, collecting, and analyzing these efficacy parameters are not specified. The trial's design and execution will adhere to standard clinical trial protocols, ensuring rigorous and systematic evaluation of the investigational product's efficacy. The absence of detailed efficacy endpoints and assessment tools in the provided data suggests that these elements will be defined in the comprehensive trial protocol document, which will guide the trial's conduct and data analysis.