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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
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.
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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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had cancer in the last 5 years, except for certain skin cancers or low-grade cervical changes.My heart's electrical activity is normal as per my doctor.I have been diagnosed with hereditary or sporadic CAA, confirmed by genetic testing or MRI according to Boston criteria.
Research Study Groups:
This trial has the following groups:- Group 1: AMDX-2011P 100 mg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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