A Study of AMDX-2011P in Participants With CAA

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).

Conditions

Cerebral Amyloid Angiopathy

Talk to us

Study Overview

On this page

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 cerebral amyloid angiopathy (CAA).

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

A Study of AMDX-2011P in Participants With CAA

Condition
Cerebral Amyloid Angiopathy
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. 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. Abnormality consistent with CAA on historical MRI.
  • 3. In general good health
  • 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. Clinically significant laboratory abnormalities assessed by the investigator.
  • 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. 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.

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

2024-12