Disease Progression in Women With X-linked Adrenoleukodystrophy

Launched by MINORYX THERAPEUTICS, S.L. · Dec 11, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how X-linked adrenoleukodystrophy (ALD) progresses in women. ALD is a genetic condition that affects the nervous system and can lead to various health challenges. The trial is observational, meaning researchers will observe and collect information without giving participants any specific treatment. It takes place in France and is currently looking for women aged 18 and older who have been diagnosed with ALD. To participate, women must be willing to have annual follow-up visits, which include MRI scans of the brain and spinal cord.

Eligible participants need to provide written consent and be part of a French social security system. However, women who are pregnant or breastfeeding, have specific medical conditions, or are currently enrolled in other clinical trials cannot participate. By joining this study, participants will help researchers better understand how ALD affects women over time, which could lead to improved care and treatment options in the future.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Women aged 18 years old or older.
• • 2. Diagnosis of X-linked ALD based on genetic testing, altered VLCFA levels, or family history.
• • 3. Willing to undergo annual follow-up visits, including brain and spinal cord MRI scans.
• • 4. Provision of written informed consent.
• • 5. Affiliation or beneficiary of a French social security system or of such a regime.
• Exclusion Criteria:
• • 1. Any condition that in the opinion of the investigator are likely to adversely affect the study participation, interfere with study compliance, or confound the study results.
• • 2. Under treatment or previous treatment with leriglitazone.
• • 3. Pregnant or lactating women.
• • 4. Subjects benefiting from laws aimed at protecting vulnerable adults: subjects being deprived of liberty by judicial or administrative decision, subjects under guardianship.
• • 5. Participation in an interventional clinical trial.