NCT05709314 A Study of AMDX-2011P in Participants With CAA
| NCT ID | NCT05709314 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Amydis Inc. |
| Condition | Cerebral Amyloid Angiopathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2024-07-09 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 25 participants in total. It began in 2024-07-09 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05709314 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cerebral Amyloid Angiopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05709314 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05709314 currently recruiting?
Yes, NCT05709314 is actively recruiting participants. Contact the research team at info@amydis.com for enrollment information.
Where is the NCT05709314 trial being conducted?
This trial is being conducted at Phoenix, United States.
Who is sponsoring the NCT05709314 clinical trial?
NCT05709314 is sponsored by Amydis Inc.. The trial plans to enroll 25 participants.