Clinical trial NCT03718494: Continuation of The Kronos Early Estrogen Prevention Study (KEEPS)
Official title: Prevention of Alzheimer's Disease in Women: Risks and Benefits of Hormone Therapy -Continuation of: "The Kronos Early Estrogen Prevention Study (KEEPS)"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Dementia
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Columbia University
name: Yale University
name: Utah State University
name: Brigham and Women's Hospital
name: Banner Alzheimer's Institute
name: University of California, San Francisco
name: National Institute on Aging (NIA)
First posted: 2018-10-24
Enrollment: 299
Sex: FEMALE
Minimum age (years): 49
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women that participated in the Kronos Early Estrogen Prevention Study (KEEP; NCT00154180) and completed brain imaging or cognitive testing and indicated that it would be acceptable to contact them for future research opportunities.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Aβ PET SUVR
timeFrame: 4 years
measure: WMH volume
timeFrame: 4 years
measure: Regional cortical thickness
timeFrame: 4 years
measure: AV-1451
timeFrame: 4 years
measure: Global cognitive function
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Health
state: Arizona
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: New York
country: United States
facility: Columbia University
state: New York
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: Mayo Clinic
name: Kejal Kantarci, M.D.
role: PRINCIPAL_INVESTIGATOR
References: