SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report


Report for Clinical Trial NCT02233868

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

Brain Inflammation and Function in Alcoholism

Background: - Brain inflammation due to high alcohol intake may affect thinking, memory, and concentration. Researchers want to measure this using positron emission tomography (PET). Objective: - To study how excessive alcohol consumption affects brain function. Eligibility: - Adults 30-75 years old who are moderate or severe alcohol drinkers. - Healthy volunteers. Design: - Participants will be screened with medical history, physical exam, interview, and blood and urine tests. Their breath will be tested for alcohol and recent smoking. - Phase 1: - Participants will stay in the hospital 3 days. They will have blood and heart tests and daily urine tests. - A small plastic tube will be inserted by needle in each arm. One will go in a vein, the other in an artery. - Participants will have 2 PET scans with 2 different radioactive compounds. Participants will lie on a bed that slides in and out of the scanner with a cap on their head. - Participants will have magnetic resonance imaging (MRI) scans. Participants will lie in the scanner either resting with their eyes open or while performing an attention task. - Participants will have tests of memory, attention, concentration, and thinking. They may answer questions, take tests, and perform simple actions. - Phase 2 of the study will only be done if Phase 1 results show brain inflammation. - Phase 2 will repeat Phase 1. - For healthy volunteers, Phase 2 will begin 3 weeks after Phase 1. - Other volunteers must not have alcohol for at least 3 weeks and stay in a hospital up to 4-6 weeks between Phase 1 and Phase 2. After Phase 2, they will have 5 follow-up calls over 3 months.

NCT02233868 Alcoholism
MeSH: Inflammation Alcoholism Encephalitis
HPO: Encephalitis

3 Interventions

Name: MRI

Description: Functional Connectivity Magnetic Resonance Imaging (fcMRI) of connectivity in brain

Type: Device

Name: C-11PBR28

Description: PET brain imaging of neuroinflammation using the radiotracer [11C]PBR28

Type: Drug

Name: F-18FDG

Description: PET brain imaging of neurofunction using the radiotracer F-18FDG

Type: Drug


Primary Outcomes

Measure: To assess if there is inflammation in the brain of alcoholics as measured with [11C]PBR28 and to determine if it recovers with 3 weeks of detoxification.

Time: 2020

Secondary Outcomes

Measure: To assess the impact of neuroinflammation on brain function (assessed with PET and 18FDG and with MRI for fMRI with task activation and for functional connectivity).

Time: 2020

Measure: To determine if the NP variables correlate with neuroinflammation.

Time: 2020

Measure: To determine if the measure of neuroinflammation predicts relapse in AD participants in the 3 month follow-up period.

Time: 2020

Purpose: Basic Science

Allocation: Non-Randomized

Parallel Assignment


There is one SNP

SNPs


1 rs6971

Homozygosity for the rs6971 polymorphism on TSPO that results in LB (Owen et al 2011) (genotyping results).



HPO Nodes


HPO:
Encephalitis
Genes 30
IL10 IKBKG IL12A L2HGDH XIAP CCR1 UBAC2 C4A BCL10 LBR ATRX HLA-B FAS SH2D1A CIITA ERAP1 RFX5 RFXAP IL12A-AS1 KLRC4 PRF1 RFXANK MEFV IL23R STAT1 BTK STAT4 TMEM70 TLR4 SLC6A19