MedPath

Study to identify blood-derived biomarkers indicative for initiation and progression of X-linked adrenoleukodystrophy

Conditions
Healthy volunteers
E71.3
Disorders of fatty-acid metabolism
Registration Number
DRKS00022930
Lead Sponsor
Center for Brain Research, Medical University of Vienna
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
400
Inclusion Criteria

Inclusion criteria for plasma/serum remnant samples from X-ALD patients are:
1) diagnosis of X-ALD by measurement of very long-chain fatty acids in the blood
2) patient details (sex and age) are known at time of blood donation
3) available data on the clinical course of the disease
4) knowledge on medication and supplementation of the patient

Inclusion criteria for plasma/serum remnant samples from healthy controls are:
1) patient details (sex and age) are known at time of blood donation
2) no diagnosis of X-ALD or other disorders associated with neurodegeneration or neuroinflammation

Exclusion Criteria

Exclusion criteria for plasma/serum remnant samples from X-ALD patients and controls are:
Intake of lipid lowering and anti-inflammatory medication

Study & Design

Study Type
observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary endpoints of this study are the blood level of neurofilament light chain protein and the epigenetic status of cell free DNA isolated from the plasma. The primary endpoints will be determined by single molecule array (SiMoA) technique and next generation sequencing.
Secondary Outcome Measures
NameTimeMethod
The secondary endpoint of this study is whether the identified differences in the amount of neurofilament light chain protein and epigenetic status of cell free DNA correlate with the progression of AMN and/or CALD.
© Copyright 2025. All Rights Reserved by MedPath