All > Amyloidosis

Cohort 1 for Amyloidosis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Columbia University Irving Medical Center, New York, NYAmyloidosisI 124-Evuzamitide - Drug
Eligibility
50 - 105
All Sexes
What conditions do you have?
Select

Study Summary

This trial will assess if 124I-evuzamitide PET scanning can identify ATTR-CM in patients with heart failure and increased wall thickness not currently diagnosed with ATTR-CM.

Eligible Conditions
  • Amyloidosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

3 Primary · 0 Secondary · Reporting Duration: Up to 1 month after scanning

Month 1
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

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Florbetaben
1
18F-flutemetamol
1
Active Arm, Zota Cohort 2

Trial Design

3 Treatment Groups

Cohort 1
1 of 3
Cohort 2
1 of 3
Cohort 3
1 of 3

Experimental Treatment

25 Total Participants · 3 Treatment Groups

Primary Treatment: Cohort 1 · No Placebo Group · Phase 2

Cohort 1
Drug
Experimental Group · 1 Intervention: I 124-Evuzamitide · Intervention Types: Drug
Cohort 2
Drug
Experimental Group · 1 Intervention: I 124-Evuzamitide · Intervention Types: Drug
Cohort 3
Drug
Experimental Group · 1 Intervention: I 124-Evuzamitide · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 month after scanning

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,312 Previous Clinical Trials
1,623,941 Total Patients Enrolled
3 Trials studying Amyloidosis
555 Patients Enrolled for Amyloidosis
Attralus, Inc.Industry Sponsor
4 Previous Clinical Trials
109 Total Patients Enrolled
4 Trials studying Amyloidosis
109 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

Eligibility Criteria

Age 50 - 105 · All Participants · 17 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a condition called ATTR-CM, which has specific characteristics that have been defined by medical professionals.
You have a specific type of heart disease called ATTR-CM and either have extra amyloid protein build-up outside of the heart (confirmed by biopsy) or symptoms that suggest this extra build-up (like nerve problems, carpal tunnel syndrome, or spinal stenosis).
References

Frequently Asked Questions

What is the overall enrollment of participants in this experiment?

"Affirmative. Clinicaltrials.gov attests that this clinical trial, posted on December 1st 2022, is currently admitting participants. 25 individuals are sought out from a single location for participation in the study." - Anonymous Online Contributor

Unverified Answer

Are participants in this clinical study required to be over the age of 20?

"This study has specific requirements for potential participants, as those aged 50 to 105 are eligible. Additionally, 2 trials have been initiated for individuals under 18 years of age and 97 trials are taking place with patients over 65." - Anonymous Online Contributor

Unverified Answer

Are there any openings still available to participants in this experiment?

"Affirmative. According to clinicaltrials.gov, this ongoing medical study is currently seeking volunteers. The trial was initially posted in December 1st 2022 and most recently updated on November 23rd 2022 with the goal of recruiting 25 patients from one site." - Anonymous Online Contributor

Unverified Answer

Is it feasible for me to participate in this medical experiment?

"This clinical trial is enrolling 25 individuals who have transthyretin amyloidosis and are between 50 and 105 years of age." - Anonymous Online Contributor

Unverified Answer

Is Cohort 1 authorized by the FDA?

"Due to the nature of this Phase 2 trial, lacking evidence for efficacy and having some safety data, Cohort 1 was rated a 2 on our team's scale." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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