A Study of AMDX-2011P in Participants With CAA

Launched by AMYDIS INC. · Jan 24, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called AMDX-2011P for people with a condition known as Cerebral Amyloid Angiopathy (CAA). CAA affects the blood vessels in the brain and can lead to serious problems like strokes. The researchers want to find out if a single intravenous (IV) dose of AMDX-2011P is safe to use, how well it works, and how it behaves in the body. The study is currently looking for participants aged 65 to 74 who have been diagnosed with hereditary or sporadic CAA and have had at least one brain MRI that shows signs of the condition.

To take part in this trial, participants should be in generally good health and have a confirmed diagnosis of CAA. However, certain health issues, like serious heart problems or active cancers, may prevent someone from joining. If you participate, you will receive the IV treatment and will be monitored closely by the research team to ensure your safety throughout the study. This trial is an important step in understanding how to better treat CAA and improve the quality of life for those affected.

Gender

ALL

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.