Continuation of The Kronos Early Estrogen Prevention Study (KEEPS)

Mayo Clinic

Status and phase: Completed; Phase 4

Conditions: Alzheimer Dementia

Treatments: Diagnostic Test: F-18 Florbetapir Positron Emission Tomography (PET) Imaging; Diagnostic Test: F-18 AV-1451 Positron Emission Tomography (PET) Imaging; Diagnostic Test: Brain Magnetic Resonance Imaging (MRI); Other: Neuropsychological Testing

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03718494

1RF1AG057547-01 (U.S. NIH Grant/Contract)

12-008697

Details and patient eligibility

About

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.

Full 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.

Enrollment: 299 patients

Sex: Female

Ages: 49 to 72 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

299 participants in 2 patient groups

Menopausal Hormone Therapy (mHT) Group

Description:

Women that participated in and completed the KEEPS study (NCT00154180) that were randomized to receive menopausal hormone therapy (mHT) will have a follow up brain Positron Emission Tomography (PET) imaging (F-18 Florbetapir PET or F-18 AV-1451 PET) and cognitive function testing.

Treatment:

Diagnostic Test: F-18 Florbetapir Positron Emission Tomography (PET) Imaging

Diagnostic Test: F-18 AV-1451 Positron Emission Tomography (PET) Imaging

Diagnostic Test: Brain Magnetic Resonance Imaging (MRI)

Other: Neuropsychological Testing

Placebo Group

Description:

Women that participated in and completed the KEEPS study (NCT00154180) that were randomized to receive placebo treatment will have a follow up brain Positron Emission Tomography (PET) imaging (F-18 Florbetapir PET or F-18 AV-1451 PET) and cognitive function testing.

Treatment:

Diagnostic Test: F-18 Florbetapir Positron Emission Tomography (PET) Imaging

Diagnostic Test: F-18 AV-1451 Positron Emission Tomography (PET) Imaging

Diagnostic Test: Brain Magnetic Resonance Imaging (MRI)

Other: Neuropsychological Testing