Continuation of The Kronos Early Estrogen Prevention Study (KEEPS)

Completed

• Conditions: Alzheimer Dementia

• 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.

Study Timeline

• Study First Submitted: 2018-10-23
• Study First Submitted QC: 2018-10-23
• Study First Posted: 2018-10-24
• Study Start: 2019-05-22
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-13
• Last Update Posted: 2023-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 299

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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.

Trial Locations

Locations (6)

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