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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
Study Summary
This trial tests how safe an IV drug is for people with a brain blood vessel disorder (CAA). #clinicaltrial #IVdrug #CAA
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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
AMDX-2011P Adverse Events Profile
Secondary outcome measures
Biological Activity
Concentration of AMDX-2011P
Pharmacokinetic Analysis of AMDX-2011P
Trial Design
1Treatment groups
Experimental Treatment
Group I: AMDX-2011P 100 mgExperimental Treatment1 Intervention
AMDX2011P 100mg (4ml) single bolus injection intravenous for diagnostic review
Find a Location
Who is running the clinical trial?
National Institute on Aging (NIA)NIH
1,675 Previous Clinical Trials
28,020,860 Total Patients Enrolled
Amydis Inc.Lead Sponsor
2 Previous Clinical Trials
86 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,825 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants still being solicited for this experiment?
"As per the records on clinicaltrials.gov, this trial is no longer recruiting participants; it was first listed on February 1st 2023 and had its most recent update on January 24th 2023. Unfortunately, there are not any available slots for patients at present but 100 other studies are currently seeking volunteers."
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