Summary

for females (full criteria)
healthy people welcome
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

Official Title

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

Details

The objectives are to assess the long-term risks and benefits of menopausal hormone therapy (mHT) on Alzheimer's disease (AD) pathophysiology, cerebrovascular, cognitive, and mood health in women treated with transdermal 17β-estradiol (tE2) or oCEE compared to placebo within three years of menopause, which is considered to be the "critical window" for mHT.

The Primary Objective is to determine the differences in Alzheimer's Disease biomarkers , cerebrovascular lesion load and brain structure in postmenopausal women who were treated with one of two mHTs vs. placebo after 13 years post-randomization and 9 years after the end of mHT administration phase.

This project is proposed as a continuation to the Kronos Early Estrogen Prevention Study (KEEPS), a nationwide, multi-center, randomized blinded study of mHT in recently menopausal women.

The current investigation will include assessments conducted within a six-week interval over 2- 3 visits, Participants will be on study for up to 3 months while completing medical assessment, questionnaires, blood work, neurocognitive studies, ECG, brain MRI, brain PET.

Keywords

Alzheimer Dementia Dementia Alzheimer Disease Estrogens F-18 AV-1451 PET F-18 Florbetapir

Eligibility

You can join if…

Open to females

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.

You CAN'T join if...

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.

Locations

  • University of California San Francisco
    San Francisco California 94158 United States
  • Banner Health
    Phoenix Arizona 85032 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Mayo Clinic
ID
NCT03718494
Phase
Phase 4
Study Type
Interventional
Last Updated