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)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05709314

Enrollment

Registered

2023-02-02

Start date

2024-07-09

Completion date

2026-12-01

Last updated

2026-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Amyloid Angiopathy

Keywords

CAA

Brief 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.

Interventions

DRUGAMDX-2011P

AMDX-2011P single bolus injection intravenous for diagnostic review

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

Phase 2, open-label, single arm, masked endpoint multicenter study

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

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

Countries

United States

Contacts

CONTACTMatthew Lehman

info@amydis.com8599050402

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026