NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Early Detection of Neuropathy in ATTRv
Early Detection of Neuropathy in ATTRv

NCT05311488

CompletedN/A

Sponsor: University of Pennsylvania

Conditions: Hereditary Amyloidosis, Transthyretin-Related

Interventions: neurofilament light chain, In-vivo Meissner Corpuscle imaging, Nerve conduction study

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 30 Years to 90 Years

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria:

Patients with known TTR mutations and neuropathy

1. Patients with TTR mutation and no symptoms within less than 10 years of typical onset of disease
2. Age criteria must meet the following:

   * Non V122I mutations, Age 40 or older.
   * V122 I mutations, 55 or older.

Healthy persons without neuropathy

1. The following distribution of age ranges will be considered when enrolling healthy participants:

   * 5 patients age 30-40
   * 5 patients age 40-50
   * 5 patients age 50-60
   * 5 patients age 60-70
2. 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.

Exclusion Criteria:

1. Patients with neuropathy other than TTR amyloid
2. Subjects with risk factors for neuropathy (diabetes, history of neuropathy in the family, neurotoxic drugs) or with neurological disorder associated with elevated NFL
Locations (1)
  • Philadelphia, Pennsylvania, United States