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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).
Full 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.
Enrollment
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Inclusion criteria
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.
Exclusion criteria
Primary purpose
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Interventional model
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36 participants in 4 patient groups
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Central trial contact
Masoud Mokhtarani, MD
Data sourced from clinicaltrials.gov
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