Evaluation of [18F]ACI-15916 as a PET Radioligand for Imaging α-Synuclein Pathology in Parkinson's Disease, Dementia with Lewy Bodies, and Multiple System Atrophy

The primary objective of this Phase 1 study is to evaluate **[18F]ACI-15916** as a potential PET radioligand for imaging **α-synuclein** deposits in the brain of patients with suspected **α-synuclein pathology**. This is clinically relevant as it aims to improve diagnostic imaging for conditions such as **Parkinson's Disease**, **Dementia with Lewy Bodies**, and **Multiple System Atrophy**, which are associated with α-synuclein deposits. Enhanced imaging techniques could lead to better diagnosis and understanding of these neurodegenerative disorders.

The clinical trial involves participants diagnosed with **Parkinson's Disease**, **Dementia with Lewy Bodies**, and **Multiple System Atrophy**. The study population includes both male and female subjects, with an age range that encompasses adults and older adults. The trial population was selected to include a vulnerable population, although specific selection criteria and the total number of participants have not been disclosed by the sponsor. Participants' general health status and lifestyle considerations such as diet, physical activity, or habits have not been specified. The sponsor has not provided detailed information regarding key inclusion or exclusion criteria for this study.

The clinical trial is a **Phase 1** study designed to evaluate the potential of **[18F]ACI-15916** as a PET radioligand for imaging **α-synuclein** deposits in the brain. The study involves patients with suspected **α-synuclein** pathology, including those with **Parkinson's Disease**, **Dementia with Lewy Bodies**, and **Multiple System Atrophy**, compared to healthy volunteers. The trial employs a randomized, double-blind, controlled design to ensure the reliability and validity of the results. The estimated recruitment start date is March 3, 2025, with an anticipated end date of March 31, 2026, indicating a total trial duration of approximately one year.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This visit will involve a comprehensive evaluation to confirm the presence of **α-synuclein** pathology or the absence thereof in healthy volunteers. Following the screening, participants will be randomized into either the treatment or control group. Subsequent follow-up visits will be scheduled to monitor the safety and efficacy of the radioligand, as well as to collect imaging data. These visits will occur at regular intervals throughout the study period. The end-of-study visit will mark the conclusion of the participant's involvement, during which final assessments will be conducted to evaluate the primary and secondary endpoints of the trial.

The expected length of participant involvement is contingent upon the trial's schedule, with each participant expected to remain in the study until the end-of-study visit unless specific conditions necessitate early termination. Such conditions may include adverse events, withdrawal of consent, or any other factors that compromise the participant's safety or the integrity of the study. The trial is conducted in accordance with ethical guidelines and regulatory requirements to ensure the safety and well-being of all participants.

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 treatments 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 designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 1 study, indicating an early stage of clinical research primarily focused on safety and dosage. The estimated recruitment start date is March 3, 2025, with an anticipated end date of March 31, 2026. Although specific efficacy parameters such as primary or secondary endpoints are not detailed, typical Phase 1 trials often involve preliminary assessments of efficacy alongside safety evaluations. These assessments may include the use of validated scales, laboratory tests, or patient-reported outcomes to measure potential therapeutic effects. The data collected will be analyzed to determine the initial efficacy profile of the investigational product, guiding further research in subsequent trial phases.