Continuation of The Kronos Early Estrogen Prevention Study (KEEPS)
Condition: Alzheimer Dementia
MeSH terms: Alzheimer Disease
Study type: Observational

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.
    

Intervention name(s): Brain Magnetic Resonance Imaging (MRI); F-18 Florbetapir Positron Emission Tomography (PET) Imaging; F-18 AV-1451 Positron Emission Tomography (PET) Imaging; Neuropsychological Testing
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test; Other
Intervention description(s): 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.; 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.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women that participated in the Kronos Early Estrogen Prevention Study (KEEP; NCT00154180)
        and completed brain imaging or cognitive testing and indicated that it would be acceptable
        to contact them for future research opportunities.