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A Study of AMDX-2011P in Participants With Alzheimer's Disease
RecruitingPhase 2
A Phase 2, Open Label, Study of AMDX-2011P as a Retinal Tracer in Participants With Alzheimer's Disease
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: 1. Confirmed diagnosis of Alzheimer's Disease (AD) with documented positive amyloid beta signal via positron emission tomography (PET) brain scan 2. Must be willing to consent to genotyping for apolipoprotein E (APOE) 3. Ability to fixate and undergo retinal imaging of both eyes 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. Diagnosis of glaucoma, or suspect of having glaucoma in either eye as determined by an ophthalmologist as a clinical investigator, based on results from the eye examination, visual field, and/or optical coherence tomography (OCT) results 3. Diagnosis of intermediate dry, wet/neovascular, or geographic atrophy forms of age-related macular degeneration (AMD) in either eye, OR as determined by an ophthalmologist as a clinical investigator, based on results from the eye examination and/or optical coherence tomography (OCT) results 4. Clinically significant laboratory abnormalities as assessed by the investigator 5. Prolonged QTcF (corrected QT interval by Fridericia method) (\>450 ms for males and \>470 ms for females), cardiac arrhythmia, or any clinically significant abnormality in the resting electrocardiogram (ECG), as judged by the investigator.
About the study
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).
What is being tested
- AMDX-2011P (drug)
Sponsor: Amydis Inc. · Participants: 25 · Started: Mar 7, 2025
Contact the study team
- Matthew Lehman · Phone: 8599050402
Official record on ClinicalTrials.gov — NCT06514001
Locations in the U.S.
| Arizona | Associated Retina Consultants, Phoenix |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.