A Phase 2, Open-Label Study of AMDX-2011P as a Retinal Tracer in Participants With Cerebral Amyloid Angiopathy (CAA)
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
• Abnormality consistent with CAA on historical MRI.
• In general good health
Locations
United States
Arizona
Associated Retina Consultants
RECRUITING
Phoenix
California
Global Research Management
RECRUITING
Glendale
Eye Research Foundation
RECRUITING
Newport Beach
Contact Information
Primary
Joyce Simpauco, MPH
joyce@amydis.com
858-254-7435
Backup
David P. Bingaman, DVM, PhD
david.bingaman@amydis.com
Time Frame
Start Date: 2024-07-09
Estimated Completion Date: 2024-12
Participants
Target number of participants: 25
Treatments
Experimental: AMDX-2011P 100 mg
AMDX2011P 100mg (4ml) single bolus injection intravenous for diagnostic review
Related Therapeutic Areas
Sponsors
Leads: Amydis Inc.
Collaborators: National Institute on Aging (NIA), National Institutes of Health (NIH)