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Report for Clinical Trial NCT04057807

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

PBR28 Brain PET Imaging With Lipopolysaccharide (LPS) Challenge for the Study of Microglia Function in Alzheimer's Disease

To examine the differences in the capacity to activate microglia in patients with Alzheimer's Disease (AD) compared to age-comparable cognitively normal subjects and younger healthy controls.

NCT04057807 Alzheimer Disease
MeSH:Alzheimer Disease
HPO:Alzheimer disease

1 Interventions

Name: LPS

Description: LPS (0.4 ng/kg)
Type: Drug
Group Labels: 1

Patients receiving endotoxin

Primary Outcomes

Description: Th primary outcome is MARI (calculated in the parietal ROIs) in AD patients compared to elderly controls. The investigators will use 7 AD and 7 comparably aged cognitively normal successfully scanned subjects to calculate the microglial activation reserve index. It is expected that there will be significant differences between the two groups suggesting Altered reactivity of the microglia in AD.The result would be an exciting one suggesting at least one mechanism by which some patients with significant amyloid load have progressive dementia while comparable others are either cognitively normal or have stable MCI. It will also suggest avenues for intervention in amyloid positive MCIs to prevent progression to Alzheimer's dementia

Measure: An altered reactivity of microglia

Time: 180 minutes post intervention

Secondary Outcomes

Description: The investigators will evaluate the effects of aging on MARI. Comparisons will be made for MARI between cognitively normal elderly and the 8 healthy individual to whom the researchers applied this protocol in an earlier study. The reactivity of microglia is reported to change with age (11) and so MARI is expected to change in the cognitively normal elderly. However, it is expected that the differences between the young and elderly cognitively normal subjects to be small relative to the comparison of AD and elderly normal controls.

Measure: Effects of aging on MARI

Time: 180 minutes post intervention

Description: The investigators will look at the relationship of regional and global amyloid load to MARI. The presence of a relationship suggests that one of the reasons for altered microglial reactivity might be interactions of microglia with pathologic amyloid.

Measure: Effects of amyloid on MARI

Time: 180 minutes post intervention

Description: The investigators will explore whether MARI would correlate with measure of disease stage, with higher MARIs associated with worse neuropsychological score and more severe disease. The investigators will look for correlations between MARI and the individual neuropsychological scores. This would determine if disease severity is correlated with microglial activation reserve.

Measure: Effects of MARI on cognition

Time: 180 minutes post intervention

Purpose: Diagnostic

Allocation: Randomized

Parallel Assignment

There is one SNP


1 rs6971

- BMI > 35 or < 19 - Women who are pregnant or nursing, or fail to use one of the following methods of birth control unless she or partner is surgically sterile or she is postmenopausal (hormone contraceptives [oral, implant, injection, patch, or ring], contraceptive sponge, double barrier [diaphragm or condom plus spermicide], or Intrauterine Device (IUD) - Individuals who are classified as "low binders" for the rs6971 polymorphism (<10% of the population) - Patients on antiplatelet and anticoagulant medications will be excluded.

HPO Nodes