COMPLETED

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

Conditions

Parkinson Disease Amyotrophic Lateral Sclerosis Parkinsons ALS

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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

Quick Facts

Study Start:2022-08-24

Study Completion:2023-03-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05542576

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. 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). 2. No suspected atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis, or degenerative diseases. 3. Confirmed diagnosis of ALS with both upper and lower motor neuron involvement. 4. Ability to undergo retinal imaging. 5. 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. 6. 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.	1. Presence of any underlying physical or psychological medical condition that would make it unlikely that the subject will complete the study per protocol. 2. Clinically significant laboratory abnormalities assessed by the investigator. 3. 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. 4. 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. 5. 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). 6. Use of any new prescription therapies or vaccines within 7 days prior to the study drug administration. 7. 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. 8. Administration of investigational product in another study within 30 days prior to the first study drug administration, or five half-lives, whichever is longer. 9. Females who are pregnant or breastfeeding.

Inclusion Criteria

Exclusion Criteria

1. 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).
2. No suspected atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis, or degenerative diseases.
3. Confirmed diagnosis of ALS with both upper and lower motor neuron involvement.
4. Ability to undergo retinal imaging.
5. 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.
6. 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.

1. Presence of any underlying physical or psychological medical condition that would make it unlikely that the subject will complete the study per protocol.
2. Clinically significant laboratory abnormalities assessed by the investigator.
3. 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.
4. 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.
5. 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).
6. Use of any new prescription therapies or vaccines within 7 days prior to the study drug administration.
7. 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.
8. Administration of investigational product in another study within 30 days prior to the first study drug administration, or five half-lives, whichever is longer.
9. Females who are pregnant or breastfeeding.

Contacts and Locations

Principal Investigator

Masoud Mokhtarani, MD

STUDY_CHAIR

Amydis Inc.

Study Locations (Sites)

Eye Research Foundation

Newport Beach, California, 92663

United States

Brittany NIcholl

Pasadena, California, 91107

United States

Collaborators and Investigators

Sponsor: Amydis Inc.

Masoud Mokhtarani, MD, STUDY_CHAIR, Amydis Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-24

Study Completion Date2023-03-15

Study Record Updates

Study Start Date2022-08-24

Study Completion Date2023-03-15

Terms related to this study

Keywords Provided by Researchers

Parkinsons
ALS

Additional Relevant MeSH Terms

Parkinson Disease
Amyotrophic Lateral Sclerosis