Status:
TERMINATED
Multimodal Imaging Outcome Measures for ALS (Image ALS)
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Biogen
University of Miami
Conditions:
ALS
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The primary aim of this study is to determine whether longitudinal neuroimaging acquired across multiple research and clinical centers is a feasible biomarker to use as an outcome measure for clinical...
Detailed Description
ALS is a progressive neurodegenerative disorder that manifests with extensive clinical heterogeneity, including variable degrees of upper motor neuron (UMN) and lower motor neuron (LMN) impairment. Wh...
Eligibility Criteria
Inclusion
- Inclusion criteria for participants in PET sub-study (Penn Only):
- Enrolled in the MRI study at Penn.
- Willing to participate in a 30 minute \[18F\]-FDG and 1.5 hour \[11C\]-PBR28 PET scan within 15 days baseline and longitudinally at the 3-month and 6-month follow-up visits, if able.
- Exclusion criteria for PET sub-study participants:
- Females who are pregnant at the time of study visits will not be eligible for the PET sub-study; urine or serum pregnancy test will be performed in women of child-bearing potential at each of the baseline, 3-month, and 6-month study visit.
- Homozygous genotype for the threonine-associated substitution allele (A) in the rs6971 polymorphism.
- Blood glucose less than or equal to 250 mg/dl, or at the discretion of the authorized user
Exclusion
Key Trial Info
Start Date :
February 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2022
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT04490096
Start Date
February 25 2021
End Date
March 17 2022
Last Update
April 12 2022
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104