CompletedNot Applicable

Early Detection of Neuropathy in ATTRv

United States47 participantsStarted 2022-02-14

Plain-language summary

The purpose of the study is to evaluate and compare different tools that are used to detect evidence of peripheral neuropathy in patients with TTRv.

Age range30 Years – 90 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Patients with TTR mutation and no symptoms within less than 10 years of typical onset of disease
✓. Age criteria must meet the following:
✓. The following distribution of age ranges will be considered when enrolling healthy participants:
✓. Healthy control subjects for this study are defined as subjects with no symptoms of neuropathy or risk factors for neuropathy such as family history of hereditary neuropathy, chemotherapy, diabetes, autoimmune disease, or vitamin deficiency. Their status will be verified by medical records review.

✕. Patients with neuropathy other than TTR amyloid
✕. Subjects with risk factors for neuropathy (diabetes, history of neuropathy in the family, neurotoxic drugs) or with neurological disorder associated with elevated NFL

Change in Serum neurofilament light chain

Timeframe: 12 months

Meissner corpuscles

Timeframe: 12 months

NCT IDNCT05311488

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-11-01