Continuation of The Kronos Early Estrogen Prevention Study (KEEPS)

CompletedOBSERVATIONAL
Enrollment

299

Participants

Timeline

Start Date

May 22, 2019

Primary Completion Date

September 1, 2022

Study Completion Date

September 1, 2022

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.

Trial Locations (6)

10027

Columbia University, New York

84112

University of Utah, Salt Lake City

85032

Banner Health, Phoenix

94158

University of California San Francisco, San Francisco

06520

Yale University, New Haven

02115

Brigham and Women's Hospital, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Columbia University

OTHER

collaborator

Yale University

OTHER

collaborator

Utah State University

OTHER

collaborator

Brigham and Women's Hospital

OTHER

collaborator

Banner Alzheimer's Institute

OTHER

collaborator

University of California, San Francisco

OTHER

collaborator

National Institute on Aging (NIA)

NIH

lead

Mayo Clinic

OTHER