NCT03718494

Continuation of The Kronos Early Estrogen Prevention Study (KEEPS)

Prevention of Alzheimer's Disease in Women: Risks and Benefits of Hormone Therapy -Continuation of: "The Kronos Early Estrogen Prevention Study (KEEPS)"

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 299 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 49 Years – 72 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate how blood flow to the brain affects cognition in women who are postmenopausal, and how the use of hormone therapy early in menopause might change brain function. The testing in this study will add to the knowledge about brain aging in women. Researchers will determine if blood flow to the brain, brain structure, and cognition differences among women who took hormones in the past as part of Kronos Early Estrogen Prevention Study (KEEPS; NCT00154180), are currently taking hormones, or never took menopausal hormones.

Detailed description

This is a continuation of the Kronos Early Estrogen Prevention Study (KEEPS) (KEEPS; NCT00154180), a multicenter double blinded, placebo-controlled, randomized trial funded by the Kronos Longevity Research Institute, Phoenix, AZ to test the hypothesis that hormone therapy started early in menopause (within the "window of opportunity") would slow progression of atherosclerosis as measured by changes in carotid artery intima-medial thickening and coronary arterial calcification. This study will involve a single follow-up evaluation of brain imaging and cognitive function of women who were randomized to menopausal hormone therapy (mHT) or placebo, approximately 13 years post-randomization and nine years after the end of mHT administration phase in KEEPS (NCT00154180). No interventions are given as part of this study; any current hormonal treatments are by choice and prescribed by the participant's personal physician.

Conditions

• Alzheimer Dementia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Brain Magnetic Resonance Imaging (MRI)	Performed on a single 3T system and sequences will be acquired in a single sitting with an exam time under 45 minutes.
DIAGNOSTIC_TEST	F-18 Florbetapir Positron Emission Tomography (PET) Imaging	After a 50-minute uptake period, the patient will be positioned on the scanner bed with instructions to remain motionless. Injection of 10 mCi of 18F-Florbetapir (target dose 370 MBq, range 296 - 444 MBq) given. A helical CT image will be obtained at 50 minutes after injection of 18F-Florbetapir, followed by a 20-minute PET acquisition consisting of four 5-minute dynamic frames.
DIAGNOSTIC_TEST	F-18 AV-1451 Positron Emission Tomography (PET) Imaging	Intravenous bolus injection of approximately 370 MBq (10 mCi) of 18F- AV-1451 (approved under IND 124449). PET/CT image acquisition will include a low dose CT and then a 20-minute PET acquisition starting at 50-60 minutes after injection of 18F-T807 and will be performed as 4, 5-minute frames that will then be summed into one static frame. Serial frames will allow for adjustment in the case of patient motion.
OTHER	Neuropsychological Testing	A comprehensive battery of standardized neuropsychological tests administered by trained personnel.

Timeline

• Start date: 2019-05-22
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2018-10-24
• Last updated: 2023-07-17

Locations

6 sites across 1 country: United States