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Recruiting NCT05709314

A Study of AMDX-2011P in Participants With CAA

Phase II Interventional Cerebral Amyloid Angiopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AMDX-2011P.
Who it may be relevant to
Registry conditions: Cerebral Amyloid Angiopathy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug AMDX-2011P
    AMDX-2011P single bolus injection intravenous for diagnostic review

Primary outcome measures

  • AMDX-2011P Adverse Events Profile [Time frame: 8 days]
Secondary outcome measures (3)
  • Concentration of AMDX-2011P [Time frame: 2 hours]
  • Pharmacokinetic Analysis of AMDX-2011P [Time frame: 2 hours]
  • Biological Activity [Time frame: 8 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Associated Retina Consultants — Phoenix

Identifiers

NCT: NCT05709314 · AMDX-2011P-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗