RecruitingPhase 2NCT06514001

A Study of AMDX-2011P in Participants With Alzheimer's Disease

A Phase 2, Open Label, Study of AMDX-2011P as a Retinal Tracer in Participants With Alzheimer's Disease

Sponsor

Amydis Inc.

Enrollment

25 participants

Start Date

Mar 7, 2025

Study Type

INTERVENTIONAL

Conditions

Alzheimer Disease

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).

Eligibility

Min Age: 18 Years

Inclusion Criteria3

Confirmed diagnosis of Alzheimer's Disease (AD) with documented positive amyloid beta signal via positron emission tomography (PET) brain scan
Must be willing to consent to genotyping for apolipoprotein E (APOE)
Ability to fixate and undergo retinal imaging of both eyes

Exclusion Criteria5

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
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
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
Clinically significant laboratory abnormalities as assessed by the investigator
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.