Continuation of The Kronos Early Estrogen Prevention Study (KEEPS)

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.

Conditions

• Alzheimer Dementia

Interventions

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

• Columbia University

  collaborator OTHER

• Yale University

  collaborator OTHER

• Utah State University

  collaborator OTHER

• Brigham and Women's Hospital

  collaborator OTHER

• Banner Alzheimer's Institute

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• National Institute on Aging (NIA)

  collaborator NIH

• Mayo Clinic

  lead OTHER

Principal Investigators

• Kejal Kantarci, M.D. · Mayo Clinic

Eligibility

Min Age

49 Years

Max Age

72 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-05-22

Primary Completion

2022-09-01

Completion

2022-09-01

Countries

• United States

Study Locations