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Clinical Trial Summary

The purpose of this research study is to assess safety and tolerability of a single intravenous (given through a vein) dose of the investigational retinal tracer AMDX-2011P in patients with neurodegenerative diseases (Parkinson's disease and ALS).


Clinical Trial Description

This study will also evaluate the ability of AMDX-2011P to identify α-syn in the retina of patients with Parkinson's disease and to identify the protein TDP-43 in the retina of patients with ALS. This study will help to evaluate the ability to detect these protein deposits for the purpose of diagnosing PD and ALS. To determine the safest dose, participants will receive different amounts of the investigational retinal tracer. The first group of participants taking part in the study will receive a low dose of AMDX-2011P. If no major side effects occur, the dose will be increased for the next group of participants. Participants will receive a 1 time intravenous injection. This study plans to enroll approximately 24-36 subjects with active disease (PD or ALS). Participants will be age 18 and older. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05542576
Study type Interventional
Source Amydis Inc.
Contact Masoud Mokhtarani, MD
Phone 310-229-5710
Email masoud@amydis.com
Status Recruiting
Phase Phase 1/Phase 2
Start date August 24, 2022
Completion date December 2023

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