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Evuzamitide Imaging for Amyloidosis
Phase 2
Waitlist Available
Led By Mathew Maurer, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
TTR genotype shown to be either Val122Ile or wild type
Left ventricular septal OR inferolateral wall thickness ≥12 mm with echocardiographic features of ATTR-CM (low tissue doppler velocities, preserved apical strain, elevated E/E') or CMR features of an infiltrative cardiomyopathy (increased wall thickness with delayed enhancement or difficulty nulling of the myocardium)
Must not have
Active malignancy or non-amyloid disease with expected survival of less than 1 year
Chronic kidney disease requiring hemodialysis or peritoneal dialysis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 month after scanning
Awards & highlights
No Placebo-Only Group
Summary
This trial uses a special imaging technique to look for changes in the hearts of patients with a specific heart condition after treatment. The scan helps doctors see harmful protein deposits in the heart, which can indicate if the treatment is working.
Who is the study for?
This trial is for adults with thickened heart walls and signs of cardiac amyloidosis, who can consent to the study. It's not for those with primary or secondary amyloidosis unrelated to transthyretin, pregnant women, patients on certain blood thinners, or anyone with a life expectancy under one year due to other diseases.
What is being tested?
The trial tests I 124-Evuzamitide as a PET scan imaging agent in detecting cardiac and extra-cardiac amyloid deposits in patients suspected of having ATTR-CM but have inconclusive standard scans. It aims to improve diagnosis accuracy for specific genetic variants associated with this condition.
What are the potential side effects?
Potential side effects are not explicitly listed here; however, as with any PET scan procedure using radiotracers like I 124-Evuzamitide, there may be risks related to radiation exposure and possible allergic reactions to the tracer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My genetic test shows I have the Val122Ile mutation or no mutation.
Select...
My heart has thick walls and signs of a specific type of heart disease.
Select...
I have a grade 1 Tc99-PYP scan with signs of heart amyloidosis or confirmed by biopsy.
Select...
My heart pumps well (EF>40%).
Select...
I have ATTR-CM and signs of amyloidosis outside my heart, like nerve issues or carpal tunnel.
Select...
My tests show amyloid deposits in my heart or other tissues.
Select...
My heart condition allows me to perform daily activities with slight or moderate limitations.
Select...
I had a Tc99-PYP scan for heart issues, but it didn't confirm the condition.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a serious illness with a life expectancy of less than 1 year.
Select...
I am on dialysis for chronic kidney disease.
Select...
I am currently on heparin or similar medications for blood thinning.
Select...
I am on a continuous IV medication to strengthen my heart.
Select...
I have been diagnosed with primary or secondary amyloidosis.
Select...
I do not have any impairments from stroke, injury, or other conditions that would stop me from joining the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 month after scanning
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 month after scanning
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
COV in subjects who are allele carriers with non-diagnostic PYP scans
COV in subjects with ATTR-CM
COV in subjects with heart failure and grade 1 PYP scans
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Group I: Cohort 3Experimental Treatment1 Intervention
Subjects with ATTR-CM from either ATTRwt or Val122Ile variant who have biopsy proven evidence of extra-cardiac TTR amyloidosis or clinical suspicion of extracardiac disease, including but not limited to peripheral neuropathy, carpal tunnel syndrome, spinal stenosis will be administered single dose evuzamitide \<1mCi..
1. ATTR-CM defined by the following
1. Amyloid deposits in cardiac or non-cardiac tissue confirmed by Congo Red (or equivalent) staining OR technetium scintigraphy with 99m Tc-pyrophosphate with Grade 2 or 3 cardiac uptake in the absence of abnormal light chains ratio,
2. End-diastolic interventricular septum thickness of \> 12 mm on previous echocardiogram
2. TTR genotype shown to be either Val122Ile or wild type.
Group II: Cohort 2Experimental Treatment1 Intervention
Subjects with TTR variant such as Phe64Leu, late onset Val30Met, etc.) that are associated with cardiac amyloidosis but have PYP scans not diagnostic of ATTR-CM will be administered single dose evuzamitide \<1mCi.
1. Tc99-PYP scan performed for clinical suspicion of ATTR-CM that is not diagnostic of ATTR-CM
2. No evidence of monoclonal proteins by assessment of serum kappa and lambda free light chain ratio and immunofixation of serum and urine.
3. Left ventricular septal OR inferolateral wall thickness ≥12 mm with echocardiographic features of ATTR-CM (low tissue doppler velocities, preserved apical strain, elevated E/E') or CMR features of an infiltrative cardiomyopathy (increased wall thickness with delayed enhancement or difficulty nulling of the myocardium)
Group III: Cohort 1Experimental Treatment1 Intervention
Subjects with grade 1 Tc99-PYP scans who have clinical features suggestive of ATTR-CM or have grade 1 Tc99-PYP scans but endomyocardial biopsy evidence of TTR cardiac amyloidosis will be administered single dose evuzamitide \<1mCi.
1. Heart failure with a preserved ejection fraction (EF\>40%)
2. Grade 1 Tc99-PYP scan performed for clinical suspicion of ATTR-CM
3. No evidence of monoclonal proteins by assessment of serum kappa and lambda free light chain ratio and immunofixation of serum and urine.
4. Left ventricular septal OR inferolateral wall thickness ≥12 mm
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
I 124-Evuzamitide
2022
Completed Phase 2
~30
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
Common treatments for Amyloidosis include immunotherapy, radiolabeled compounds for amyloid visualization, and stem cell transplantation. Immunotherapy targets proteins involved in amyloid binding and aggregation, potentially reducing amyloid accumulation.
Radiolabeled compounds like 124I-evuzamitide are used in PET scans to visualize amyloid deposits, aiding in diagnosis and monitoring treatment efficacy. Stem cell transplantation aims to treat underlying plasma cell dyscrasias, particularly in AL amyloidosis, by replacing diseased cells with healthy ones.
These treatments are crucial as they help manage amyloid burden, improve organ function, and enhance patient outcomes.
Efficacy of chronic BACE1 inhibition in PS2APP mice depends on the regional Aβ deposition rate and plaque burden at treatment initiation.Anti-apoE immunotherapy inhibits amyloid accumulation in a transgenic mouse model of Aβ amyloidosis.A clinico-epidemiological study of macular amyloidosis from north India.
Efficacy of chronic BACE1 inhibition in PS2APP mice depends on the regional Aβ deposition rate and plaque burden at treatment initiation.Anti-apoE immunotherapy inhibits amyloid accumulation in a transgenic mouse model of Aβ amyloidosis.A clinico-epidemiological study of macular amyloidosis from north India.
Find a Location
Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,480 Previous Clinical Trials
2,621,833 Total Patients Enrolled
5 Trials studying Amyloidosis
2,518 Patients Enrolled for Amyloidosis
Attralus, Inc.Industry Sponsor
6 Previous Clinical Trials
325 Total Patients Enrolled
6 Trials studying Amyloidosis
325 Patients Enrolled for Amyloidosis
Mathew Maurer, MDPrincipal InvestigatorColumbia University
1 Previous Clinical Trials
15 Total Patients Enrolled
1 Trials studying Amyloidosis
15 Patients Enrolled for Amyloidosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart's interventricular septum is thicker than 12 mm on a recent echocardiogram.I have a serious illness with a life expectancy of less than 1 year.You have a ventricular assist device.My genetic test shows I have the Val122Ile mutation or no mutation.My heart has thick walls and signs of a specific type of heart disease.My heart failure is not mainly due to amyloidosis.I am on dialysis for chronic kidney disease.I am currently on heparin or similar medications for blood thinning.I am on a continuous IV medication to strengthen my heart.My heart pumps well (EF>40%).My condition is confirmed as ATTR-CM.I have a grade 1 Tc99-PYP scan with signs of heart amyloidosis or confirmed by biopsy.I have ATTR-CM and signs of amyloidosis outside my heart, like nerve issues or carpal tunnel.My tests show amyloid deposits in my heart or other tissues.I have a TTR gene variant linked to heart issues but my scan doesn't show heart amyloidosis.You have severe memory or behavior problems.My heart condition allows me to perform daily activities with slight or moderate limitations.I have been diagnosed with primary or secondary amyloidosis.The walls of your heart are thicker than normal.There should be no signs of abnormal proteins in the blood and urine.You have had a specific type of scan called a Grade 1 Tc99-PYP scan to check for a heart condition called ATTR-CM.I had a Tc99-PYP scan for heart issues, but it didn't confirm the condition.I do not have any impairments from stroke, injury, or other conditions that would stop me from joining the study.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1
- Group 2: Cohort 2
- Group 3: Cohort 3
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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