Evaluating AMDX-2011P for treating cerebral amyloid angiopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Associated Retina Consultants
  Phoenix, Arizona, United States Recruiting

Study contacts

• Study coordinator: Matthew Lehman
• Email: info@amydis.com
• Phone: 8599050402

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.