A Phase 2, Open Label, Study of AMDX-2011P as a Retinal Tracer in Participants With Alzheimer's Disease
NCT: NCT06514001 ·
Status: RECRUITING ·
Phase: Phase 2
· Sponsor: Amydis Inc.
· Started: 2025-03-07
· Est. Completion: 2026-10
Official 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 Alzheimer's Disease (AD).
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 25 participants
Interventions
- DRUG: AMDX-2011P — AMDX-2011P single bolus injection intravenous for diagnostic review
Primary Outcomes
- AMDX-2011P Adverse Events Profile (8 days)
Secondary Outcomes
- Concentration of AMDX-2011P (2 hours)
- Pharmacokinetic Analysis of AMDX-2011P (2 hours)
- Biological Activity (8 days)
Trial Locations
- Associated Retina Consultants, Phoenix, Arizona, United States
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AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.