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

• Register: ClinicalTrials.gov
• Last refreshed on: 13 February 2023
• Main ID: NCT05542576
• Date of registration: 07/09/2022
• Prospective Registration: No
• Primary sponsor: Amydis Inc.
• Public title: AMDX-2011P Retinal Tracer in Subjects With Neurodegenerative Diseases Associated With Amyloidogenic Proteinopathy PROBE
• Scientific title: Prospective Randomized Open, Blinded Endpoint (PROBE) Study of AMDX-2011P as a Retinal Tracer in Subjects With Neurodegenerative Diseases Associated With Amyloidogenic Proteinopathy
• Date of first enrolment: August 24, 2022
• Target sample size: 36
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT05542576
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Masoud Mokhtarani, MD
• Affiliation: Amydis Inc.

• Name: Masoud Mokhtarani, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

For Subjects with Parkinson's Disease

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.

For Subjects with ALS

3. Confirmed diagnosis of ALS with both upper and lower motor neuron involvement.

For All Subjects

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.

Exclusion Criteria:

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis

Parkinson Disease

Intervention(s)

Drug: AMDX2011P

Primary Outcome(s)

AMDX-2011P adverse events profile [Time Frame: 1 week]

Secondary Outcome(s)

Concentration of AMDX-2011P [Time Frame: 8 hours]

Detection of a-syn and TDP-43 deposits in retina [Time Frame: 8 hours]

Pharmacokinetic Analysis of AMDX-2011P [Time Frame: 8 hours]

Secondary ID(s)

AMDX-2011P

Source(s) of Monetary Support

Please refer to primary and secondary sponsors