MedPath

Examining Neuroinflammation in AlzHeimer's

Completed
Conditions
Alzheimer Disease, Early-Onset
Registration Number
NCT03548883
Lead Sponsor
AdventHealth
Brief Summary

Alzheimer disease (AD) is a neurodegenerative disorder with a poorly understood pathology. It is an irreversible progressive brain disease that slowly deteriorates memory, thinking and behavior. It affects the elderly population and is also hereditary. The incidence doubles with every decade after sixty with no signs of leveling off. More than 35 million people Worldwide, including 5.5 million living in the United States, suffer from AD. As the United States population ages, it is expected that the number of people with AD will increase, reaching 13.2 to 16.0 million by the year 2050. The cost of care for patients with AD in the United States is expected to rise as well, from $172 billion a year in 2010 to a trillion dollars a year by 2050.

Although the exact etiopathology is not known there are several lines of evidence that suggest that metabolic and inflammatory features are important. It also has been known for many years that the Blood Brain Barrier (BBB) of Alzheimer's patients allow more harmful particles to cross into the brain than the BBBs of those without the disease do. It's known that this barrier, which is regulating transfer of molecules between the brain and blood, and vice versa blood and brain, can become leaky and dysfunctional (in particular capillaries dysfunction) and lead to subsequent problems likely contributing to onset and progression of dementia. This protocol will explore several of the most promising putative factors that cause AD.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
14
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
GenderTwo years

(Male or Female)

AdiponectinTwo years

Measured of adiponectin level in the blood

HeightTwo years

Measured in meters

Lipid profileTwo years

Measured of the HDL, LDL and VLDL content in the blood (measured in mg/dL)

Compare the Blood Brain Barrier leaking between AD, T2D and healthy control subjects.Two years

A MRI of the brain with contrast will be used to assess the permeability of the Blood Brain Barrier.

AgeTwo years

Measured in years

BMITwo years

will be determined by dividing weight by height (square)

Body compositionTwo years

Measured by Dexascan

WeightTwo years

Measured in kilograms

RaceTwo years

White/Black or African American/Asian/Other/Unknown or not reported

InsulinTwo years

Measured of insulin level in the blood

Cognitive dataTwo years

Evaluated by the Geriatric Depression Scale (GDS)

Free Fatty AcidTwo years

Measured of free fatty acid level in the blood

Transcriptomic profiles of the cells isolated from the bloodTwo years

after isolation of the peripheral blood mononuclear cell (PBMC) from the blood, measure of gene expression by RT-qPCR (real time quantitative polymerase chain reaction)

Activity monitoring - lying down timeTwo years

measured by wearing an arm band - measured in minutes

Activity monitoring - energy cost of free-living activityTwo years

measured by wearing an arm band - measured in minutes

EpigeneticTwo years

after isolation of the PBMC from the blood measure of DNA methylation

Proteomic of the cells isolated from the bloodTwo years

after isolation of the PBMC from the blood, measure of proteins by western blot

Metabolic of the cells isolated from the bloodTwo years

after isolation of the PBMC from the blood measure of metabolites by MS

Activity monitoring - sleeping timeTwo years

measured by wearing an arm band - measured in minutes

Secondary Outcome Measures
NameTimeMethod
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