Amyotrophic Lateral Sclerosis Clinical Trial
Official title:
An Open-label, Adaptive Design Study in Patients With Amyotrophic Lateral Sclerosis (ALS) to Characterize Safety, Tolerability and Brain Microglia Response, as Measured by TSPO Binding, Following Multiple Doses of BLZ945 Using Positron Emission Tomography (PET) With the Radioligand [11C]-PBR28
It is an open label study to evaluate safety, tolerability and brain microglia response in participants with ALS following multiple doses of BLZ945.
The purpose of the study is to identify a dose (or doses) of BLZ945, that measurably decrease(s) TSPO binding in the brain of participants with ALS, to evaluate the safety and tolerability of BLZ945 in participants with ALS at these doses and dosing regimens, and safety related effects on ECM accumulation. In Cohort 5, TSPO PET will be performed in a dedicated cohort (PET sub-study) while the remainder of Cohort 5 participants will undergo CSF-based biomarker analyses. ;
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