AMDX-2011P Retinal Tracer in Subjects With Neurodegenerative Diseases Associated With Amyloidogenic Proteinopathy — PROBE  

Parkinson Disease Clinical Trial

Official title: Prospective Randomized Open, Blinded Endpoint (PROBE) Study of AMDX-2011P as a Retinal Tracer in Subjects With Neurodegenerative Diseases Associated With Amyloidogenic Proteinopathy

Status Recruiting

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. ;

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Neurodegenerative Diseases
• Parkinson Disease

• 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