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Retinal Tracer

AMDX-2011P for Cerebral Amyloid Angiopathy

Phase 2
Recruiting
Research Sponsored by Amydis Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 days
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new drug called AMDX-2011P, given through an IV injection, in people with cerebral amyloid angiopathy (CAA). The study will check how safe the drug is, how it moves through the blood, and its effects on the body. Special attention will be given to changes in the eyes.

Who is the study for?
Adults diagnosed with hereditary or sporadic Cerebral Amyloid Angiopathy (CAA) who can undergo retinal imaging and have no other causes of cerebral hemorrhage. Participants must not be pregnant, breastfeeding, or have a recent history of malignancy. They should agree to use contraception and avoid sperm or oocyte donation for specified periods post-study drug administration.
What is being tested?
The trial is testing the safety and tolerability of AMDX-2011P, an investigational retinal tracer administered intravenously once to patients with CAA. The study involves monitoring participants' reactions after receiving this potential new diagnostic tool.
What are the potential side effects?
While specific side effects are not listed, the study aims to assess the safety and tolerability of AMDX-2011P in patients. Potential side effects may include reactions at the infusion site, allergic responses, or any unforeseen impacts on vision due to its nature as a retinal tracer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
AMDX-2011P Adverse Events Profile
Secondary study objectives
Biological Activity
Concentration of AMDX-2011P
Pharmacokinetic Analysis of AMDX-2011P

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: AMDX-2011P 100 mgExperimental Treatment1 Intervention
AMDX2011P 100mg (4ml) single bolus injection intravenous for diagnostic review

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Cerebral Amyloid Angiopathy (CAA) focus on targeting amyloid deposits in cerebral blood vessels. These treatments often involve immunotherapy, which uses antibodies to recognize and clear amyloid-beta plaques, thereby reducing vascular damage and improving cognitive function. Investigational agents like AMDX-2011P are designed to assess the safety, tolerability, and biological activity of targeting these amyloid deposits. This approach is crucial for CAA patients as it directly addresses the underlying pathology of amyloid accumulation, potentially slowing disease progression and mitigating symptoms associated with vascular damage in the brain.

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,766 Previous Clinical Trials
28,184,815 Total Patients Enrolled
Amydis Inc.Lead Sponsor
3 Previous Clinical Trials
111 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,798 Previous Clinical Trials
8,141,500 Total Patients Enrolled

Media Library

AMDX-2011P (Retinal Tracer) Clinical Trial Eligibility Overview. Trial Name: NCT05709314 — Phase 2
Cerebral Amyloid Angiopathy Research Study Groups: AMDX-2011P 100 mg
Cerebral Amyloid Angiopathy Clinical Trial 2023: AMDX-2011P Highlights & Side Effects. Trial Name: NCT05709314 — Phase 2
AMDX-2011P (Retinal Tracer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05709314 — Phase 2
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