E2: Sex Hormones and Alzheimer's Disease Prevention Study

What is E2?

 

This two year observational study looks to determine the relationship between blood and brain sex hormones and Alzheimer's disease risk factors during middle age.

You can check out our flyer for the study here.

If you are interested in participating please call 404-712-9823 or 404-712-7085 to complete a phone screening.

Who is being studied?

 

This study is recruiting both men and women, but will have a larger proportion of women enrolled as they experience a more significant change in hormones throughout their lives. The women enrolled will be divided into five different categories for data analysis:

  • Pre-menopausal women

  • Peri/menopausal women taking horomone replacement therapy (HRT)

  • Peri/menopausal women not taking HRT

  • Post-menopausal women taking HRT

  • Post-menopausal women not taking HRT

To be eligible for this study, you must meet the following criteria:

  • Age 45-85 years

  • Have a healthy blood pressure or controlled high blood pressure

  • Self-reported normal cognition, subjective memory complaints, or diagnosis of Mild Cognitive Impairment (MCI) - participants must be able to consent for themselves

  • Score of ≥ 15 on telephone MMSE (completed during phone screen)

  • Willing to undergo all study procedures

  • Willing to fast for eight hours

You may NOT be eligible if you meet these criteria:

  • Currently in another investigational drug study

  • Unable to undergo an LP or MRI for medical reasons (blood thinner, some spine abnormalities, metal implants, etc)

  • Residence in a skilled nursing facility

  • Are pregnant or nursing

  • Any systemic illness or medical condition which would cause difficulty complying with study procedures or consenting for oneself

  • Heart failure

  • Significant neurological disease, stroke, TBI, or history of significant head trauma

  • Untreated Major Depression within 2 years of study enrollment

  • History of alcohol or substance abuse or dependence

What is involved?

 

If you participate in this research you will attend 3 to 5 study visits over the course of two years. These visits can be anywhere from 2 to 7 hours long, depending on how the procedures are split up. Some procedures will require that you fast for 8 or more hours prior. Procedures that will occur at these visits include:

  • An MRI scan of your brain

  • Cognitive testing

  • Medical and health related questionnaires

  • Blood samples

  • Neurological Exam

  • Lumbar puncture (if you have questions about this procedure, please go here)

  • Pulse Wave Velocity (aka Vascular Ultrasound)

  • Overnight sleep monitor

Study Locations

 

This study is being conducted at three different Emory University locations:

Wesley Woods Health Center, 2nd floor - MRI

1821 Clifton Rd

Atlanta, GA  30307

Emory Alzheimer's Clinical Research Unit (ACRU)

6 Executive Park Dr, 2nd floor

Atlanta, GA 30329

Emory Brain Health Center

12 Executive Park Dr, 5th floor, Green Side

Atlanta, GA 30329

Project Funding

 

This grant was funded by the National Institute on Aging (NIA), a division of the National Institute of Health, in 2019. It has a funding period of five years.

Why is this research important?

 

Two thirds of the 5.7 million Americans living with Alzheimer’s disease (AD) are women, but definitive mechanisms connecting female sex to increased AD risks remain largely unexplored. There are neuroanatomical differences between men and women including total brain size (about 10% larger in men than women across the lifespan), regional brain size, neuronal density, and synaptic patterns. Proportions of gray and white matter also differ between men and women, in that women have a higher percentage of gray matter and men a higher percentage of white matter. What’s more, the relationship between sex and change in brain volume is cognition-dependent: whereas brain volume tends to decline faster in men than in women with normal cognition, brain volume declines faster in women than men with MCI or AD. Because traditional gender roles additionally impact other AD risks including stress, education ascertainment, and caregiving responsibilities, it can be extraordinarily difficult to derive mechanisms from longitudinal association studies without mediating measures and biomarkers to reflect these sex- and gender-related constructs. While prior studies of middle-aged women at risk for AD have explored one or two AD biomarkers, the E2 Study plans to greatly expand the number and types of biomarkers to examine their relationships to AD biomarkers.

WHITNEY WHARTON​

LABORATORY 

 

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