The Kronos Early Estrogen Prevention Study (KEEPS)
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Alzheimer Disease, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/8/2019 |
| Start Date: | March 2019 |
| End Date: | June 2022 |
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
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.
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.
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.
(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.
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.
We found this trial at
6
sites
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