Evaluating AMDX-2011P for treating cerebral amyloid angiopathy

A Phase 2, Open-Label Study of AMDX-2011P as a Retinal Tracer in Participants With Cerebral Amyloid Angiopathy (CAA)

This study is testing a new drug called AMDX-2011P to see if it is safe and effective for people with cerebral amyloid angiopathy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Amydis Inc. (Industry-sponsored)
• Locations: 1 site (Phoenix, Arizona)
• Trial ID: NCT05709314 on ClinicalTrials.gov

What this trial studies

This interventional study aims to assess the safety, tolerability, plasma pharmacokinetics, and biological activity of a single intravenous dose of AMDX-2011P in participants diagnosed with cerebral amyloid angiopathy (CAA). Participants will undergo retinal imaging and safety assessments before and after the administration of the drug. The study is open-label with masked endpoint assessments to ensure unbiased evaluation of outcomes. Blood samples will be collected to analyze pharmacokinetics following the drug administration.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with hereditary or sporadic CAA who have undergone prior brain MRI.

Not a fit: Patients with significant underlying health conditions or active malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from cerebral amyloid angiopathy.

How similar studies have performed: While this approach is novel, similar studies targeting CAA have shown promise in evaluating new treatments.

Eligibility criteria

Inclusion Criteria:

1. Diagnosis of hereditary CAA or probable and definite symptomatic or asymptomatic sporadic CAA diagnosed through genetic testing or according to the modified Boston neuroradiological criteria, who had undergone at least one brain magnetic resonance imaging (MRI)prior to entry into study.
2. Abnormality consistent with CAA on historical MRI.
3. In general good health

Exclusion Criteria:

1. Presence of any underlying physical or psychological medical condition that, in the opinion of the investigator, would make it unlikely that the participant 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.

Where this trial is running

Phoenix, Arizona

• Associated Retina Consultants — Phoenix, Arizona, United States (Recruiting)

Study contacts

• Study coordinator: Matthew Lehman

Conditions Cerebral Amyloid Angiopathy; CAA