RecruitingPhase 2

A Study of AMDX-2011P in Participants With CAA

United States25 participantsStarted 2024-07-09

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

AMDX-2011P Adverse Events Profile

Timeframe: 8 days

Trial details

NCT IDNCT05709314

SponsorAmydis Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

Matthew Lehman

8599050402 info@amydis.com

View on ClinicalTrials.gov More Cerebral Amyloid Angiopathy trials