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Report for Clinical Trial NCT02559869
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
Imaging and BioFluid Biomarkers in Amyotrophic Lateral Sclerosis
This is a multicenter, 18-month study, which aims to identify imaging and biofluid biomarkers in people with ALS to expand the understanding of ALS pathology, treatment targets, disease progression, and anatomical differences between different disease phenotypes. This pilot project is tailored to produce imaging tools that will allow researchers to conduct future ALS clinical trials more efficiently which may in turn impact the pace for ALS drug discovery.
NCT02559869 Amyotrophic Lateral Sclerosis (ALS) MeSH:Motor Neuron Disease Amyotrophic Lateral Sclerosis Sclerosis
HPO:Abnormal anterior horn cell morphology Amyotrophic lateral sclerosis
1 Interventions
Name: [18F] GE-180
Primary Outcomes
Description: Aim 1 will be accomplished by obtaining [18F] GE-180 PET imaging from 25 people with ALS compared to 25 age, gender, and binding affinity matched healthy volunteers.
Measure: Measure & localize brain inflammation in people with ALS via [18F] GE-180 PET imaging. Time: 12 monthsDescription: Aim 1 will be accomplished by obtaining state of-the-art MRI acquisition sequences from 50 people with ALS compared to 50 MRI age- and gender-matched healthy volunteers.
Measure: Define anatomical, structural, and functional changes in the brain via MRI of ALS Subjects vs. Healthy Controls at Baseline Time: 12 monthsDescription: Blood from 100 subjects will be studied to quantitate circulating pro- and anti-inflammatory monocyte/macrophage and T cells, with results to be correlated with neuroimaging and evaluated as potential biomarkers of disease progression.
Measure: Determine systemic inflammatory factors that may modify the progression or other clinical or imaging correlates of ALS. Time: 12 monthsSecondary Outcomes
Description: Clinical and [18F] GE-180 PET imaging data will be collected every 6 months from the 25 people with ALS for at least 12 months.
Measure: Determine the longitudinal changes in brain inflammation in people with ALS in correlation with ALS severity and rate of progression. Time: 12 monthsDescription: Clinical and MRI data will be collected every 3 months from 50 people with ALS for at least 12 months.
Measure: Determine the longitudinal changes in the anatomical, structural, and functional measures in people with ALS, and build ALS prediction models using the clinical and MRI data. Time: 12 monthsTime Perspective: Prospective
Case-Control
There is one SNP
SNPs
1 rs6971
The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair ability of the subject to provide informed consent, according to SI judgment 7. Pregnant women or women currently breastfeeding 8. Anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study In addition, any subject meeting any of the following criteria during screening evaluations will be excluded from entry into the PET portion of the study: 1. Radiation exposure that exceeds the site's current guidelines 2. Low affinity TSPO binders determined by having a Thr/Thr polymorphism in the TSPO gene (rs6971) at the Screening Visit Women of Childbearing Potential (WOCBP) For the purposes of this study, women of child bearing potential are defined as all women who are capable of becoming pregnant, unless they meet one of the following criteria: - 12-months post-menopausal - Post-hysterectomy - Surgically sterile Inclusion Criteria Study subjects meeting all of the following criteria will be allowed to enroll in the study: 1.
The presence of unstable psychiatric disease, cognitive impairment, or dementia that would impair ability of the subject to provide informed consent, according to SI judgment 7. Pregnant women or women currently breastfeeding 8. Anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study In addition, any subject meeting any of the following criteria during screening evaluations will be excluded from entry into the PET portion of the study: 1. Radiation exposure that exceeds the site's current guidelines 2. Low affinity TSPO binders determined by having a Thr/Thr polymorphism in the TSPO gene (rs6971) at the Screening Visit Women of Childbearing Potential (WOCBP) For the purposes of this study, women of child bearing potential are defined as all women who are capable of becoming pregnant, unless they meet one of the following criteria: - 12-months post-menopausal - Post-hysterectomy - Surgically sterile Amyotrophic Lateral Sclerosis (ALS) Motor Neuron Disease Amyotrophic Lateral Sclerosis Sclerosis In this trial, approximately 200 subjects will participate in this study from 2 Northeast ALS Consortium (NEALS) centers in the United States.