NCT02948062

Early Diagnosis Of Childhood Cerebral ALD

Early Diagnosis Of Childhood Cerebral Adrenoleukodystrophy

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: Male
• Age: 1 Year – 5 Years
• Healthy volunteers: Not accepted

Summary

The goal of this single institution study is to evaluate boys with adrenoleukodystrophy (ALD) diagnosed early in life, and to prospectively monitor them to determine parameters that will facilitate earlier detection of the childhood cerebral form of the disease. These at-risk subjects will be assessed yearly through travel to the University of Minnesota, where plasma and cerebral spinal fluid (CSF) biomarker studies, MRI based imaging and neuropsychological assessments will be performed at the University of Minnesota Masonic Children's Hospital and Clinics. The MRI and lumbar puncture to obtain CSF will be obtained under sedation. In addition, at intervening 6 months intervals information will be obtained remotely, including surveys and MRI's in their home location. Also at that time blood samples will be obtained locally and shipped to the University of Minnesota for study. There is no therapeutic intent in this study.

Conditions

• Adrenoleukodystrophy

Timeline

• Start date: 2018-11-01
• Primary completion: 2023-07-01
• Completion: 2023-07-01
• First posted: 2016-10-28
• Last updated: 2018-07-06

Locations

1 site across 1 country: United States