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RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "AMDX-2011P will be administered through a single IV bolus injection followed by safety assessments, retinal imaging and PK blood collection."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a single dose of AMDX-2011P given into a vein in people with Alzheimer's disease. It checks safety, how well people handle the drug, how it moves through the blood, and its effects in the body.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a confirmed diagnosis of Alzheimer's disease and a PET brain scan showing amyloid beta, a protein that builds up in the brain.
  • Agree to a test of the APOE gene.
  • Be able to hold your gaze steady and have pictures taken of the retina, the light-sensing layer at the back of each eye.

Who can't join

  • Have a physical or mental health condition that the study doctor thinks would make it hard to finish the study as planned.
  • Have glaucoma, or suspected glaucoma, in either eye, as judged by the study eye doctor. Glaucoma can damage the nerve that carries signals from the eye to the brain.
  • Have certain forms of age-related macular degeneration in either eye: intermediate dry, wet, or geographic atrophy. These conditions damage the part of the eye used for sharp, straight-ahead vision.
  • Have lab test results that the study doctor considers a major health concern.
  • Have a long delay in the heart's electrical reset time (QTcF over 450 milliseconds for males or 470 for females), an abnormal heart rhythm, or another important problem on a resting heart electrical test (ECG), as judged by the study doctor.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

AZ