What side effects are associated with this type of intervention?

Common treatments for Cerebral Amyloid Angiopathy (CAA) that target amyloid deposits include monoclonal antibodies like bapineuzumab and other amyloid-targeting agents. Known side effects of these treatments often include serious adverse events such as brain swelling (amyloid-related imaging abnormalities, ARIA), headaches, and microhemorrhages. Additionally, treatments like thalidomide, which have been hypothesized to affect amyloid deposits, can cause significant tolerability issues, including neuropathy and increased risk of infections. Patients should discuss these potential side effects with their healthcare provider to weigh the benefits and risks.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically targeting amyloid deposits in cerebral blood vessels for Cerebral Amyloid Angiopathy (CAA). The study of AMDX-2011P aims to assess the safety, tolerability, plasma pharmacokinetics, and biologic activity of this investigational drug in CAA patients. This indicates ongoing research efforts to find effective treatments for CAA, but no specific drugs have been approved for this purpose to date.

What other types of research exist?

Promising novel alternatives to AMDX-2011P for Cerebral Amyloid Angiopathy patients in 2024 may include Tau-targeting therapies, which aim to block Tau aggregation, inhibit Tau phosphorylation, or enhance Tau degradation. Additionally, other amyloid-targeting monoclonal antibodies such as Aducanumab, Crenezumab, and Gantenerumab, despite their mixed results in Alzheimer's Disease, may still hold potential for CAA treatment.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 8 days

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

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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.