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Preclinical Testing of a Novel Tracer for Imaging Alpha-synuclein Aggregates

Study Rationale: In Parkinson's disease (PD), the protein alpha-synuclein is structurally altered such that clumps of alpha-synuclein accumulate in the brain. These aggregates impair the function of nerve cells that cause neurodegeneration. Because many therapeutics currently under development target alpha-synuclein aggregates, diagnostic tests that allow measurement of these protein aggregates in urgently needed. We have developed a radioactively labeled compound, MODAG-005, that binds specifically to aggregated alpha-synuclein. This tracer should allow detection of alpha-synuclein aggregates in brain by PET imaging.  

Hypothesis: We hypothesize that MODAG-005, which achieves good spatial and temporal distribution in small models, will prove effective for detecting alpha-synuclein accumulation in preclinical models in PD. 

Study Design: In this study, we will confirm that MODAG-005 shows favorable properties in a model of PD. We will begin by establishing an efficient protocol for the radiochemical production of MODAG-005. We will then conduct an imaging study to examine the spatial and temporal distribution of MODAG-005 in the brain of pre-clinical models. In parallel, we will perform studies to confirm the safety of MODAG-005 in humans. Taken together, these studies will facilitate the development of MODAG-005 for use in clinical trials.

Impact on Diagnosis/Treatment of Parkinson's Disease: PET tracers for the detection of alpha-synuclein, the protein structurally altered in PD and related diseases, would allow for the early and differential diagnosis of these disorders and for monitoring disease progression and the efficacy of potential therapies.

Next Steps for Development: If the preclinical studies show a suitable spatial and temporal distribution profile in the body and warrant a safe application in humans, the next step will be the first clinical trial with our PET tracer Kandidate MODAG-005 in people with PD.

Next Steps for Development: If the preclinical studies show a suitable spatial and temporal distribution profile in the body and warrant a safe application in humans, the next step will be the first clinical trial with out PET tracer candidate MODAG-005 in people with PD.


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