RECRUITING

A Study of AMDX-2011P in Participants With CAA

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Conditions

Cerebral Amyloid AngiopathyCAA

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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 cerebral amyloid angiopathy (CAA).

Official Title

A Phase 2, Open-Label Study of AMDX-2011P as a Retinal Tracer in Participants With Cerebral Amyloid Angiopathy (CAA)

Quick Facts

Study Start:2024-07-09
Study Completion:2024-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05709314

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. Diagnosis of hereditary CAA or probable and definite symptomatic or asymptomatic sporadic CAA diagnosed through genetic testing or according to the modified Boston neuroradiological criteria, who had undergone at least one brain magnetic resonance imaging (MRI)prior to entry into study.
  2. 2. Abnormality consistent with CAA on historical MRI.
  3. 3. In general good health
  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. Clinically significant laboratory abnormalities assessed by the investigator.
  3. 3. Active malignancy and/or history of malignancy in the past 5 years, with the exception of completely excised non-melanoma skin cancer or low-grade cervical intraepithelial neoplasia.
  4. 4. Prolonged QTcF (\>450 ms for males and \>470 ms for females),cardiac arrhythmia, or any clinically significant abnormality in the resting ECG, as judged by the investigator.

Contacts and Locations

Study Contact

Joyce Simpauco, MPH
CONTACT
858-254-7435
joyce@amydis.com
David P. 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 Date2024-07-09
Study Completion Date2024-12

Study Record Updates

Study Start Date2024-07-09
Study Completion Date2024-12

Terms related to this study

Keywords Provided by Researchers

  • CAA

Additional Relevant MeSH Terms

  • Cerebral Amyloid Angiopathy