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A Study of AMDX-2011P in Participants With CAA | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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)

NCT05709314•Amydis Inc.

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).

Detailed Description

This open-label, masked endpoint assessment study will evaluate the safety, tolerability, plasma pharmacokinetics (PK) and biological activity of an intravenous (IV) dose of AMDX-2011P in participants with CAA. Assessments of retinal images will be conducted by central masked assessors. Participants will be admitted to the study site where eye examination and retinal imaging will be conducted before administration of the study drug. AMDX-2011P will be administered through a single IV bolus injection followed by safety assessments, retinal imaging and PK blood collection.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Associated Retina Consultants

Phoenix, Arizona, United States

Key Dates

Start Date

July 9, 2024

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2026

Last Updated

February 13, 2026

Enrollment

ESTIMATED participants

Conditions

Cerebral Amyloid Angiopathy

Interventions

AMDX-2011P

DRUG

Contacts

Matthew Lehman

CONTACT

8599050402 info@amydis.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of AMDX-2011P in Participants With CAA

Inclusion Criteria

Exclusion Criteria

Cerebellar Superficial Siderosis in Cerebral Amyloid Angiopathy

Superficial Siderosis in Patients With Suspected Cerebral Amyloid Angiopathy

Study Evaluating the Safety,Tolerability and Efficacy of PF-04360365 in Adults With Probable Cerebral Amyloid Angiopathy