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

August 28, 2026 updated by: Amydis Inc.

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This open-label, masked endpoint assessment study will evaluate the safety, tolerability, plasma pharmacokinetics (PK) and biological activity of an intravenous (IV) dose of AMDX-2011P in participants with AD. Assessments of retinal images will be conducted by central masked assessors.

Participants will be admitted to the study site where eye examination and retinal imaging will be conducted before administration of the study drug. AMDX-2011P will be administered through a single IV bolus injection followed by safety assessments, retinal imaging and PK blood collection.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AMDX-2011P 100 milligram
AMDX2011P 100 milligram (4 milliliter) single bolus injection intravenous for diagnostic review
Drug: AMDX-2011P
AMDX-2011P single bolus injection intravenous for diagnostic review

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AMDX-2011P Adverse Events Profile
Time Frame: 8 days
Incidence, nature and severity of adverse events/serious adverse events (AEs/SAEs)
8 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic Analysis of AMDX-2011P
Time Frame: 2 hours
Area under the plasma versus time curve (AUC)
2 hours
Biological Activity
Time Frame: 8 days
Detection of amyloid deposits in the retina after intravenous AMDX-2011P administration
8 days
Concentration of AMDX-2011P
Time Frame: 2 hours
Plasma Pharmacokinetic (PK) Concentration (CMax) AMDX-2011P to AMDX-2011
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amydis Inc.

Investigators

  • Study Director: David Bingaman, DVM, PhD, Amydis Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

July 17, 2024

First Submitted That Met QC Criteria

July 17, 2024

First Posted (Actual)

July 23, 2024

Study Record Updates

Last Update Posted (Actual)

August 31, 2026

Last Update Submitted That Met QC Criteria

August 28, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMDX-2011P-204

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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