Continuation of The Kronos Early Estrogen Prevention Study (KEEPS)
- Conditions
- Alzheimer Dementia
- Interventions
- Diagnostic Test: Brain Magnetic Resonance Imaging (MRI)Diagnostic Test: F-18 Florbetapir Positron Emission Tomography (PET) ImagingDiagnostic Test: F-18 AV-1451 Positron Emission Tomography (PET) ImagingOther: Neuropsychological Testing
- Registration Number
- NCT03718494
- Lead Sponsor
- Mayo Clinic
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 299
- Participated in the original KEEPS trial.
- Able to understand study procedures.
- Willing to sign an authorization of consent in order to participate in this study.
• Women who have contraindications to MRI or PET for safety reasons, such as an MRI-incompatible implant or claustrophobia.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Menopausal Hormone Therapy (mHT) Group Brain Magnetic Resonance Imaging (MRI) Women that participated in and completed the KEEPS study (NCT00154180) that were randomized to receive menopausal hormone therapy (mHT) will have a follow up brain Positron Emission Tomography (PET) imaging (F-18 Florbetapir PET or F-18 AV-1451 PET) and cognitive function testing. Placebo Group Brain Magnetic Resonance Imaging (MRI) Women that participated in and completed the KEEPS study (NCT00154180) that were randomized to receive placebo treatment will have a follow up brain Positron Emission Tomography (PET) imaging (F-18 Florbetapir PET or F-18 AV-1451 PET) and cognitive function testing. Menopausal Hormone Therapy (mHT) Group Neuropsychological Testing Women that participated in and completed the KEEPS study (NCT00154180) that were randomized to receive menopausal hormone therapy (mHT) will have a follow up brain Positron Emission Tomography (PET) imaging (F-18 Florbetapir PET or F-18 AV-1451 PET) and cognitive function testing. Placebo Group F-18 AV-1451 Positron Emission Tomography (PET) Imaging Women that participated in and completed the KEEPS study (NCT00154180) that were randomized to receive placebo treatment will have a follow up brain Positron Emission Tomography (PET) imaging (F-18 Florbetapir PET or F-18 AV-1451 PET) and cognitive function testing. Menopausal Hormone Therapy (mHT) Group F-18 Florbetapir Positron Emission Tomography (PET) Imaging Women that participated in and completed the KEEPS study (NCT00154180) that were randomized to receive menopausal hormone therapy (mHT) will have a follow up brain Positron Emission Tomography (PET) imaging (F-18 Florbetapir PET or F-18 AV-1451 PET) and cognitive function testing. Menopausal Hormone Therapy (mHT) Group F-18 AV-1451 Positron Emission Tomography (PET) Imaging Women that participated in and completed the KEEPS study (NCT00154180) that were randomized to receive menopausal hormone therapy (mHT) will have a follow up brain Positron Emission Tomography (PET) imaging (F-18 Florbetapir PET or F-18 AV-1451 PET) and cognitive function testing. Placebo Group F-18 Florbetapir Positron Emission Tomography (PET) Imaging Women that participated in and completed the KEEPS study (NCT00154180) that were randomized to receive placebo treatment will have a follow up brain Positron Emission Tomography (PET) imaging (F-18 Florbetapir PET or F-18 AV-1451 PET) and cognitive function testing. Placebo Group Neuropsychological Testing Women that participated in and completed the KEEPS study (NCT00154180) that were randomized to receive placebo treatment will have a follow up brain Positron Emission Tomography (PET) imaging (F-18 Florbetapir PET or F-18 AV-1451 PET) and cognitive function testing.
- Primary Outcome Measures
Name Time Method AV-1451 4 years This measure is derived from a PET imaging study that images the deposition of the tau protein of Alzheimer's disease in the brain
WMH volume 4 years 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.
Global cognitive function 4 years This measurement is derived from multiple neuropsychometric tests that measure various cognitive abilities.
Aβ PET SUVR 4 years This measure is derived from a PET imaging study that images the deposition of the amyloid plaques of Alzheimer's disease in the brain
Regional cortical thickness 4 years 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (6)
Columbia University
🇺🇸New York, New York, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Banner Health
🇺🇸Phoenix, Arizona, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States