Continuation of The Kronos Early Estrogen Prevention Study (KEEPS)
NCT ID: NCT03718494
Last Updated: 2023-07-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
299 participants
OBSERVATIONAL
2019-05-22
2022-09-01
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Menopausal Hormone Therapy (mHT) Group
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.
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.
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.
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.
Neuropsychological Testing
A comprehensive battery of standardized neuropsychological tests administered by trained personnel.
Placebo Group
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.
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.
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.
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.
Neuropsychological Testing
A comprehensive battery of standardized neuropsychological tests administered by trained personnel.
Interventions
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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.
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.
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.
Neuropsychological Testing
A comprehensive battery of standardized neuropsychological tests administered by trained personnel.
Eligibility Criteria
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Inclusion Criteria
* Able to understand study procedures.
* Willing to sign an authorization of consent in order to participate in this study.
Exclusion Criteria
49 Years
72 Years
FEMALE
Yes
Sponsors
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Columbia University
OTHER
Yale University
OTHER
Utah State University
OTHER
Brigham and Women's Hospital
OTHER
Banner Alzheimer's Institute
OTHER
University of California, San Francisco
OTHER
National Institute on Aging (NIA)
NIH
Mayo Clinic
OTHER
Responsible Party
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Kejal Kantarci
Professor of Radiology, Cons-Research Neuroradiology
Principal Investigators
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Kejal Kantarci, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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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
Columbia University
New York, New York, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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12-008697
Identifier Type: -
Identifier Source: org_study_id
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