Continuation of The Kronos Early Estrogen Prevention Study (KEEPS)

Alzheimer Dementia Clinical Trial

— KEEPS  

Official title:

Prevention of Alzheimer's Disease in Women: Risks and Benefits of Hormone Therapy -Continuation of: "The Kronos Early Estrogen Prevention Study (KEEPS)"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03718494
• Other study ID #: 12-008697
• Secondary ID: 1RF1AG057547-01
• Status: Completed
• Start date: May 22, 2019
• Est. completion date: September 1, 2022

Study information

• Verified date: July 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 49 Years to 72 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Women who have contraindications to MRI or PET for safety reasons, such as an MRI-incompatible implant or claustrophobia.

Related Conditions & MeSH terms

• Alzheimer Dementia
• Alzheimer Disease

Intervention

Diagnostic Test:
• 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.

Other:
• Neuropsychological Testing
A comprehensive battery of standardized neuropsychological tests administered by trained personnel.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Yale University	New Haven	Connecticut
United States	Columbia University	New York	New York
United States	Banner Health	Phoenix	Arizona
United States	University of Utah	Salt Lake City	Utah
United States	University of California San Francisco	San Francisco	California

Sponsors (8)

Lead Sponsor	Collaborator
Mayo Clinic	Banner Alzheimer's Institute, Brigham and Women's Hospital, Columbia University, National Institute on Aging (NIA), University of California, San Francisco, Utah State University, Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aß 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
Primary	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
Primary	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
Primary	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
Primary	Global cognitive function	This measurement is derived from multiple neuropsychometric tests that measure various cognitive abilities.	4 years

External Links

•   Mayo Clinic Clinical Trials