Study of AMDX-2011P as a Retinal Tracer in Subjects With Neurodegenerative Diseases Associated With Amyloidogenic Proteinopathy

Completed · Phase 1/Phase 2

Conditions studied: Parkinson Disease, Amyotrophic Lateral Sclerosis

In brief

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).

Key facts

Study ID: NCT05542576
Run by: Amydis Inc.
People needed: 13
Starts: 2022-08-24
Expected to finish: 2023-03-15
Last updated by the study team: 2025-08-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

For Subjects with Parkinson's Disease
Clinically established Parkinson's disease based on Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's disease (Table 8) and a modified Hoehn \& Yahr scale of 1-3 (Table 9).
No suspected atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis, or degenerative diseases.
For Subjects with ALS
Confirmed diagnosis of ALS with both upper and lower motor neuron involvement.
For All Subjects
Ability to undergo retinal imaging.
Subject or legally authorized representative must provide signed informed consent (or signed assent form) prior to study entry and have the ability and willingness to attend and comply with the necessary study procedures and visits at the study site. For subjects unable to physically sign the informed consent, a guardian or trusted care giver can sign on their behalf in presence of an independent witness.
Contraception use by study subjects of childbearing potential (male and female) and female partners of childrearing potential male subjects should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

You may not qualify if…

Presence of any underlying physical or psychological medical condition that would make it unlikely that the subject will complete the study per protocol.
Clinically significant laboratory abnormalities assessed by the investigator.
Active malignancy and/or history of malignancy in the past 5 years, with the exception of completely excised non-melanoma skin cancer or low-grade cervical intraepithelial neoplasia.
Prolonged QTcF (>450 ms for males and >470 ms for females), cardiac arrhythmia, or any clinically significant abnormality in the resting ECG, as judged by the investigator.
Presence of any ocular condition that would significantly hinder the ability to detect and quantify hyper-fluorescent puncta (e.g., eyes with significant hyper-autofluorescence that would mask the ability to detect, quantify, and discern post-injection hyper-fluorescent signal from pre-injection hyper-autofluorescence signal).
Use of any new prescription therapies or vaccines within 7 days prior to the study drug administration.
Drugs with potential phototoxicity per Package Insert are prohibited within 48 hours or 5 half-lives, whichever is longer, prior to first study drug until End-of-study (EOS) visit, except for those required for treatment of underlying disease.
Administration of investigational product in another study within 30 days prior to the first study drug administration, or five half-lives, whichever is longer.
Females who are pregnant or breastfeeding.

Where it is running

Eye Research Foundation — Newport Beach, California, United States
Brittany NIcholl — Pasadena, California, United States

Full record on ClinicalTrials.gov

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