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.
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.
Study Type
OBSERVATIONAL
Enrollment
299
Performed on a single 3T system and sequences will be acquired in a single sitting with an exam time under 45 minutes.
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.
Banner Health
Phoenix, Arizona, United States
University of California San Francisco
San Francisco, California, United States
Yale University
New Haven, Connecticut, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Aβ PET SUVR
This measure is derived from a PET imaging study that images the deposition of the amyloid plaques of Alzheimer's disease in the brain
Time frame: 4 years
WMH volume
This measure is derived from an MRI study that images the brain structure. WMH is measured from specific regions of the brain that are vulnerable to cerebrovascular disease related injury.
Time frame: 4 years
Regional cortical thickness
This measure is derived from an MRI study that images the brain structure. The cortical thickness is measured from specific regions of the brain that are vulnerable to Alzheimer's disease related neurodegeneration.
Time frame: 4 years
AV-1451
This measure is derived from a PET imaging study that images the deposition of the tau protein of Alzheimer's disease in the brain
Time frame: 4 years
Global cognitive function
This measurement is derived from multiple neuropsychometric tests that measure various cognitive abilities.
Time frame: 4 years
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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.
A comprehensive battery of standardized neuropsychological tests administered by trained personnel.
Columbia University
New York, New York, United States
University of Utah
Salt Lake City, Utah, United States