NCT05311488

Early Detection of Neuropathy in ATTRv

Early Detection of Peripheral Neuropathy in Hereditary Transthyretin Amyloidosis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 47 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 30 Years – 90 Years
• Healthy volunteers: Accepted

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.

Detailed description

Early detection of peripheral neuropathy in patients with TTRv is important to support initiation of therapy that alters the course of the disease. Current tools used to detect peripheral neuropathy may not be sensitive, especially in very early and distal peripheral neuropathy. This study will compare different methods of assessing for peripheral neuropathy including using in-vivo reflectance confocal microscopy to assess for meissner corpuscles, serum neurofilament light chain, quantitative sensory testing, neuropathy impairement scores, nerve conduction studies and quality of life and symptoms questionnaires.

Conditions

• Hereditary Amyloidosis, Transthyretin-Related

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	neurofilament light chain	Blood test
DIAGNOSTIC_TEST	In-vivo Meissner Corpuscle imaging	Imaging
DIAGNOSTIC_TEST	Nerve conduction study	Nerve conduction study

Timeline

• Start date: 2022-02-14
• Primary completion: 2025-11-01
• Completion: 2026-02-14
• First posted: 2022-04-05
• Last updated: 2026-03-12

Locations

1 site across 1 country: United States