RecruitingPhase 2NCT05709314

A Study of AMDX-2011P in Participants With CAA

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

Sponsor

Amydis Inc.

Enrollment

25 participants

Start Date

Jul 9, 2024

Study Type

INTERVENTIONAL

Conditions

Cerebral Amyloid Angiopathy

Summary

The purpose of this study is to assess safety, tolerability, plasma pharmacokinetics and biologic activity of a single intravenous dose of AMDX-2011P in participants with cerebral amyloid angiopathy (CAA).

Eligibility

Min Age: 18 Years

Inclusion Criteria3

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.
Abnormality consistent with CAA on historical MRI.
In general good health

Exclusion Criteria4

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.
Clinically significant laboratory abnormalities assessed by the investigator.
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.
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.

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