An observational study in Amyloidosis, Amyloid and Amyloid Neuropathies, Familial, sponsored by The Cleveland Clinic. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-03-12.
Sponsored by The Cleveland Clinic · Observational
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Among 141 studies in Amyloidosis with a site in United States — 39 open to participants now, 47 under way, 10 of them phase 3. Amyloidosis · United States.
Among the 141 studies in Amyloidosis with a site in United States, this one is the 30th largest by enrollment of the 41 observational ones that give a count, is one of 7 that started in 2018, is one of 41 observational ones, and was the 65th registered.
290 studies on the registry are indexed under Amyloidosis; 92 are open to participants now.
Browse Amyloidosis studies →39 of the 141 studies in Amyloidosis with a site in United States are open now. Recruiting first, the newest first:
Brigham and Women's Hospital · Sites in United States
Ages 18+
Eidos Therapeutics, a BridgeBio company · Sites in United States
Ages 18–80
GlaxoSmithKline · Sites in United States, Australia, United Kingdom
Ages 18+
Alnylam Pharmaceuticals · Sites in United States, Argentina, Australia and 19 more countries
Ages 18–85
Alnylam Pharmaceuticals · Sites in United States, Germany, Japan
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 70 Amyloidosis studies recruiting now, 43 (61%) set no upper age limit and 3 (4%) stop at 75 or younger; 7 take children under 18; 9 take healthy volunteers.
This study: all sexes · no healthy volunteers.
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141 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 24 · Phase 2 46 · Phase 3 31 · Phase 4 3
First in 1979; this study’s year is marked. 7 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 37 is below the median of 190 across 83 observational studies indexed under Amyloidosis.
Median enrollment 45 across the 99 interventional studies, 107 across the 41 observational. Of the 84 that completed or were terminated, 44 (52%) have results posted.
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66 of 141 have an industry lead sponsor. The 10 most frequent:
The Cleveland Clinic is the lead sponsor of 832 studies on the registry; 120 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 73 (81%) have results posted.
The Cleveland Clinic has 5 studies filed under Amyloidosis — fewer than ten, so there is no comparison to draw.
18 of the studies in Amyloidosis with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05619302Phase 3Brigham and Women's HospitalMolecular Imaging of Myocardial Fibrosis in Cardiac Amyloidosis | 2026-12-31 |
| NCT07560306Phase 3Brigham and Women's Hospital[64Cu]FBP8 PET for Early Detection of Intracardiac Thrombus in Amyloid Cardiomyopathy | 2027-03-30 |
| NCT06097832Nexcella Inc.Study of NXC-201 CAR-T in Patients With Light Chain (AL) Amyloidosis | 2026-12 |
| NCT05951816University of Tennessee Graduate School of MedicineA Phase 1 Study of 99mTc-p5+14 in Healthy Volunteers and Patients With AL or ATTR Systemic Amyloidosis | 2026-12 |
| NCT07196839University of Texas Southwestern Medical CenterDetermining the Association of TTR Stabilizing Therapy With Circulating TTR Amyloid Aggregates Over Time in Patients With ATTR-CM: Longitudinal Biomarker Study | 2026-12 |
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Among the 141 studies in Amyloidosis with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study measures circulating, misfolded ATTR oligomers in asymptomatic ATTRm amyloidosis genetic carriers longitudinally over five years.
Recent advances in genetic testing have allowed for pathogenic mutation identification in family members of affected individuals prior to onset of symptoms. While the presence of mutation and the corresponding TTR kinetic stability have been directly linked to disease development, the molecular drivers of tissue specific degeneration have not been defined. We hypothesize that soluble misfolded TTR oligomer species may be circulating within the blood of these patients possibly years prior to amyloid deposition and could serve as an early biomarker and/or driver for disease development. In this line, The Scripps Research Institute has developed a peptide-based probe that specifically labels and integrates into misfolded TTR oligomers allowing the relative circulating concentration in the bloodstream to be determined. Longitudinal monitoring of untreated, asymptomatic TTR amyloid genetic carriers utilizing the Scripps probe is likely to provide novel insight into early disease progression. We also plan to utilize the Scripps probe to monitor disease progression in TTR amyloid genetic carriers currently undergoing treatment by observing how treatments affect the circulating misfolded TTR oligomers. Through enhanced understanding of early disease progression and treatment efficacy, our hope is to limit amyloid accumulation in cardiac and nerve tissue and delay the development of the invariably fatal TTR amyloid cardiomyopathy/neuropathy.
Participants will be identified through clinical practice and from Amyloid support groups
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Exclusion Criteria:
1.) To evaluate the relative amount of misfolded ATTR oligomers in asymptomatic ATTR amyloid genetic carriers and correlate their levels with clinical symptoms and outcomes. 1. Determine if misfolded ATTR oligomers are elevated compared to healthy control data obtained by Scripps during probe development 2. Describe the levels longitudinally 3. Determine if treatment with ATTR-specific medications (examples: diflunisal, doxycycline, ursodiol, tauroursodeoxycholic acid (TUDCA), green tea extract, curcumin, tafamidis, inotersen, patisiran) lead to reduction in the probe levels in those with elevated levels at baseline
Average % change in oligomers in patients with new onset TTR amyloid symptoms
Change (%) for oligomer level at the time of TTR amyloid symptoms compared to baseline
Time frame: Annually over 5 years
% change of oligomer levels relative to baseline level in patients with ATTR specific medication changes
Change (%) for oligomer level at the time of ATTR specific medication changes compared to baseline
Time frame: Annually over 5 years
Ran from Feb 2018 to primary completion in Mar 2026, 97 months.
Of 52 observational studies under Amyloidosis, half reached primary completion within 97 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 183. This study's 97 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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