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Completed

NCT Number: NCT03718494

Continuation of The Kronos Early Estrogen Prevention Study (KEEPS)

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.

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Key information

Conditions

Alzheimer Dementia Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

49 year–72 year

Sex eligibility

Female

Study type

Observational

Primary location

Banner Health, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brain Magnetic Resonance Imaging (MRI)

Diagnostic Test

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

Diagnostic Test

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

Diagnostic Test

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

Other

A comprehensive battery of standardized neuropsychological tests administered by trained personnel.

Primary outcomes

  1. Aβ PET SUVR

    Time frame: 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

  2. WMH volume

    Time frame: 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.

  3. Regional cortical thickness

    Time frame: 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.

  4. AV-1451

    Time frame: 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

  5. Global cognitive function

    Time frame: 4 years

    This measurement is derived from multiple neuropsychometric tests that measure various cognitive abilities.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • 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

Registry information

Official study title

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

Acronym: KEEPS

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 24, 2018
Registry last updated
Jul 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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