Continuation of The Kronos Early Estrogen Prevention Study (KEEPS)
KEEPS
Prevention of Alzheimer's Disease in Women: Risks and Benefits of Hormone Therapy -Continuation of: "The Kronos Early Estrogen Prevention Study (KEEPS)"
2 other identifiers
observational
299
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2019
Typical duration for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2018
CompletedFirst Posted
Study publicly available on registry
October 24, 2018
CompletedStudy Start
First participant enrolled
May 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedJuly 17, 2023
July 1, 2023
3.3 years
October 23, 2018
July 13, 2023
Conditions
Outcome Measures
Primary Outcomes (5)
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
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.
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.
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
4 years
Global cognitive function
This measurement is derived from multiple neuropsychometric tests that measure various cognitive abilities.
4 years
Study Arms (2)
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.
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Women who have contraindications to MRI or PET for safety reasons, such as an MRI-incompatible implant or claustrophobia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- Columbia Universitycollaborator
- Yale Universitycollaborator
- Utah State Universitycollaborator
- Brigham and Women's Hospitalcollaborator
- Banner Alzheimer's Institutecollaborator
- University of California, San Franciscocollaborator
- National Institute on Aging (NIA)collaborator
Study Sites (6)
Banner Health
Phoenix, Arizona, 85032, United States
University of California San Francisco
San Francisco, California, 94158, United States
Yale University
New Haven, Connecticut, 06520, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Columbia University
New York, New York, 10027, United States
University of Utah
Salt Lake City, Utah, 84112, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kejal Kantarci, M.D.
Mayo Clinic
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Radiology, Cons-Research Neuroradiology
Study Record Dates
First Submitted
October 23, 2018
First Posted
October 24, 2018
Study Start
May 22, 2019
Primary Completion
September 1, 2022
Study Completion
September 1, 2022
Last Updated
July 17, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share
Study data will be de-identified and transferred to the Mayo Clinic and UW through secure file transfer protocols. Data will be stored at each institution's data center.