Open-label study of [11C]MODAG-005 PET radioligand safety and test-retest performance for imaging alpha-synuclein deposition in Parkinson disease and multiple system atrophy

The primary objective of this study is to evaluate the safety and test-retest reliability of the PET radioligand [11C]MODAG-005. This investigation aims to assess the utility of this tracer for imaging pathological alpha-synuclein deposition in the brains of individuals diagnosed with Parkinson's disease or multiple system atrophy. Establishing these characteristics is clinically relevant for the development of molecular imaging tools to quantify protein aggregation in neurodegenerative disorders. The study compares findings against age-matched healthy controls.

The sponsor did not provide information regarding the total number of participants. The study population consists of both male and female individuals, categorized into two groups: patients and healthy volunteers. Clinical conditions identified within the patient group include Parkinson disease and multiple system atrophy. The participants fall within specific age categories represented by codes 3 and 4.

This Phase 1, open-label, single-center study is designed to evaluate the safety and test-retest characteristics of the PET radioligand [11C]MODAG-005. The research aims to assess the imaging of pathological alpha-synuclein deposition in the brains of individuals diagnosed with Parkinson's disease or Multiple System Atrophy. These patient cohorts will be compared against age-matched healthy controls. The study methodology involves a sequence of clinical assessments, beginning with a screening visit to determine eligibility. Subsequent follow-up visits will be conducted to perform the required imaging procedures and safety evaluations. The protocol concludes with an end-of-study visit. The total duration of the study, including recruitment, is estimated to span from April 2026 to June 2027.

The clinical trial involves participants with Parkinson disease, multiple system atrophy, or healthy volunteers. Information regarding the specific parameters, methods, or instruments used to evaluate efficacy is not provided.