RECRUITING

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

Talk to us

Conditions

Alzheimer DiseaseAD

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2024-07
Study Completion:2025-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06514001

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Confirmed diagnosis of Alzheimer's Disease (AD) with documented positive amyloid beta signal via positron emission tomography (PET) brain scan
  2. 2. Must be willing to consent to genotyping for apolipoprotein E (APOE)
  3. 3. Ability to fixate and undergo retinal imaging of both eyes
  1. 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. 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. 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. 4. Clinically significant laboratory abnormalities as assessed by the investigator
  5. 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.

Contacts and Locations

Study Contact

Joyce Simpauco, MPH
CONTACT
858-254-7435
joyce@amydis.com
David Bingaman, DVM, PhD
CONTACT
david.bingaman@amydis.com

Principal Investigator

David Bingaman, DVM, PhD
STUDY_DIRECTOR
Amydis Inc.

Study Locations (Sites)

Associated Retina Consultants
Phoenix, Arizona, 85020
United States
Global Research Management
Glendale, California, 91204
United States
Eye Research Foundation
Newport Beach, California, 92663
United States

Collaborators and Investigators

Sponsor: Amydis Inc.

  • David Bingaman, DVM, PhD, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2024-07
Study Completion Date2025-03

Study Record Updates

Study Start Date2024-07
Study Completion Date2025-03

Terms related to this study

Keywords Provided by Researchers

  • AD

Additional Relevant MeSH Terms

  • Alzheimer Disease