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

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

Plain Language Summary

Simplified for easier understanding

This study is testing a new non-invasive method called retinal imaging (taking detailed photos of the back of the eye) to detect early signs of Alzheimer's disease in people who already have a confirmed diagnosis. Changes in the retina may mirror what is happening in the brain. **You may be eligible if...** - You have a confirmed diagnosis of Alzheimer's disease with positive amyloid brain scan (PET) - You are willing to have a genetic test (APOE genotyping) - You are able to have detailed images taken of both eyes **You may NOT be eligible if...** - You have been diagnosed with glaucoma, or are suspected to have glaucoma - You have intermediate or advanced macular degeneration (AMD) in either eye - You have another significant eye condition that prevents valid retinal imaging - You have a medical or psychological condition that, in your doctor's opinion, makes study participation unsafe or unlikely to be completed Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAMDX-2011P

AMDX-2011P single bolus injection intravenous for diagnostic review


Locations(1)

Associated Retina Consultants

Phoenix, Arizona, United States

View Full Details on ClinicalTrials.gov

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NCT06514001


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