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

Description

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).

Conditions

Alzheimer Disease

Study Overview

Study Details

Study overview

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).

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

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

Condition
Alzheimer Disease
Intervention / Treatment

-

Contacts and Locations

Phoenix

Associated Retina Consultants, Phoenix, Arizona, United States, 85020

Glendale

Global Research Management, Glendale, California, United States, 91204

Newport Beach

Eye Research Foundation, Newport Beach, California, United States, 92663

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Amydis Inc.,

David Bingaman, DVM, PhD, STUDY_DIRECTOR, Amydis Inc.

Study Record Dates

2025-03