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Prevention of Alzheimer’s Disease in Women: Risks and Benefits of Hormone Therapy -Continuation of: “The Kronos Early Estrogen Prevention Study (KEEPS)” Mayo Clinic IRB#2241-04-00


Brief Summary:

To assess effects of menopausal hormone therapy and normal aging on cognitive performance and
imaging markers of brain structure in women approximately thirteen years after enrolling in
the KEEPS trial. KEEPS participants were randomized to oral or transdermal estrogen
treatments or placebo within three years of menopause. This is a follow up study of these
women approximately thirteen years after randomization (9 years after study completion.) No
treatments are given as part of this study; any current hormonal treatments are by choice and
prescribed by the participant’s personal physician.


Inclusion Criteria:

Participants must meet all of the following inclusion criteria in order to participate in
this study:

– completed the KEEPS trial and underwent previous brain imaging and cognitive testing

– able to understand study procedures

– willing to sign an authorization of consent in order to participate in this study.

Exclusion Criteria:

Exclusion Criteria for Cognitive Testing:

– Current use of medications that would affect cognitive testing, including: opioids,
benzodiazepines, or antipsychotics.

– Evidence of structural brain abnormalities

Exclusion Criteria for MRI and PET imaging:

– Women who have contraindications to MRI or PET for safety reasons, such as an
MRI-incompatible implant or claustrophobia

– Women with a ECG diagnosis of torsades de pointes which is a rare cardiac arrhythmia
or additional risk factors for torsades de pointes such as women with a prolonged QT
interval (as demonstrated by ECG test) or taking drugs that prolong QT interval cannot
participate in the Tau-PET scans.


  • University of California San Francisco, San Francisco, California, United States, 94158
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