A Study of AMDX-2011P in Participants With CAA

February 11, 2026 updated by: Amydis Inc.

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AMDX-2011P 100 mg
AMDX2011P 100mg (4ml) single bolus injection intravenous for diagnostic review
Drug: AMDX-2011P
AMDX-2011P single bolus injection intravenous for diagnostic review

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AMDX-2011P Adverse Events Profile
Time Frame: 8 days
Incidence, nature and severity of AEs/SAEs
8 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic Analysis of AMDX-2011P
Time Frame: 2 hours
Area under the plasma versus time curve (AUC)
2 hours
Concentration of AMDX-2011P
Time Frame: 2 hours
Plasma PK Concentration (CMax)AMDX-2011P to AMDX-2011
2 hours
Biological Activity
Time Frame: 8 days
Detection of amyloid deposits in the retina after intravenous AMDX-2011P administration using a conventional retinal fundus fluorescence imaging device.
8 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amydis Inc.

Collaborators

National Institutes of Health (NIH)
National Institute on Aging (NIA)

Investigators

  • Study Director: David Bingaman, DVM, PhD, Amydis Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 24, 2023

First Submitted That Met QC Criteria

January 24, 2023

First Posted (Actual)

February 2, 2023

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMDX-2011P-001
  • 5SB1AG073029-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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