NCT05709314RecruitingPhase 2
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)
Source: ClinicalTrials.gov · Last updated 13 Feb 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 24 Jan 2023
- Start date
- 9 Jul 2024
- Primary completion date
- Dec 2026
- Lead sponsor
- Amydis Inc.
- NCT number
- NCT05709314
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 25
- From 9 Jul 2024 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- 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.
Lab values
- Clinically significant laboratory abnormalities assessed by the investigator.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Associated Retina Consultants Coordinator of this site? Confirm its status | Phoenix | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.