SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT03702816

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

The Relationship Between Neuropsychological Testing and MRI, PET and Blood Biomarkers in Neurodegenerative Disease (COBRE - Project 1): AIM 2

The complex pathological cascades leading to both Alzheimer's disease (AD) and Parkinson's disease (PD) involve, at various points, inflammation. Since inflammation is a treatable symptom, understanding how and when it impacts the brain, and where specifically in the brain, would offer important guidance in the development of new treatments, sorely needed in both diseases. Microglia play an important anti-inflammatory role, and produce a substance, mitochondrial translocator protein (TSPO), whose presence can be used as a marker of regional inflammation. GE180 is a newly developed PET ligand which binds to TSPO and hence can be used in imaging studies to analyze regional inflammation in living patients. In prior studies it has shown regional specificity in multiple sclerosis and brain injury. In the current study, the investigators will be using GE180 to analyze regional and global inflammation in the brains of patients with AD and PD at two time points. The results of the current study will provide enriched understanding of inflammation in these conditions, and potentially provide preliminary data to inform design of future interventional trials.

NCT03702816 Alzheimer Disease Parkinson Disease Inflammation
MeSH: Parkinson Disease Inflammation Alzheimer Disease Neurodegenerative Diseases
HPO: Alzheimer disease Neurodegeneration

1 Interventions

Name: GE180 PET Scan

Description: GE180 PET Scan

Type: Diagnostic Test

AD PD Control MCI


Primary Outcomes

Description: We will use a linear regression model to assess whether regional microglial activation is predictive of cognitive performance in domains of memory, visuospatial function, language, and executive functioning. These differing units of measurement collected through neuropsychological evaluation will be aggregated into one model in order to assess the correlations between regional activation and cognitive performance in any different domains.

Measure: Linear Regression Model Assessing Cognitive Performance and Regional Microglial Activation

Time: Baseline

Description: We will use repeated measures analyses to asses whether there is a significant change in microglial activation between year 1 scan and year 2 scan. We will then assess if this change in microglial activation over this time period relates to changes in cognitive measures.

Measure: Repeated Measures Analyses to Asses Change in Microglial Activation Over Time

Time: Baseline (Year 1) compared to Year 2

Description: We will use a linear regression model to assess whether global microglial activation is predictive of overall cognitive performance (as assessed with scores on the Dementia Rating Scale (DRS) and Montreal Cognitive Assessment (MoCA)).

Measure: Linear Regression Model Assessing Cognitive Performance and Global Microglial Activation

Time: Baseline

Purpose: Diagnostic

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 rs6971

For MCI patients, fit criteria based in Movement Disorders Task Force or NIA Exclusion Criteria: 1. Significant neurological disorders other than AD or PD; 2. Unstable medical conditions 3. History of major psychiatric diseases 4. MRI evidence of infarction or other focal lesion or multiple lacunes 5. Clinically significant abnormalities in B12 or TSH 6. Identified as having a common polymorphism (rs6971) in the TSPO gene which has been shown to reduce binding affinity of tracers similar to GE180.



HPO Nodes


HPO:
Alzheimer disease
Genes 6
PSEN2 CACNA1G APOE APP GATA1 PSEN1
Neurodegeneration
Genes 72
VAPB CCNF RNASEH2B IFIH1 NEFH PPARGC1A TARDBP TREX1 NEK1 WDR45 ERBB4 CHCHD10 OPTN GALC PANK2 ZBTB20 UBQLN2 ANG AARS2 RNASEH2A ATXN2 FIG4 FOLR1 GLE1 PDE8B SQSTM1 GUSB UBTF FA2H UCHL1 C19ORF12 MATR3 TBK1 ANXA11 RNASEH2C NAXD ATXN3 TREM2 PON1 PON2 PON3 GM2A DAO NBN PLA2G6 FTL SAMHD1 MFSD8 TAF15 ABCD1 FUS COASY TANGO2 IDS C9ORF72 PFN1 IDUA TXN2 ADAR DCTN1 LYST HNRNPA1 UNC13A NARS2 CFAP410 TTC19 PCNA SOD1 VCP CHMP2B EPHA4 PRPH