Aging and Estrogen on Cortical Function

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2013-12-02

Brief Summary

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This study will focus on how estrogen affects parts of the brain associated with memory and how the effect of estrogen is altered with aging in postmenopausal women.

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Detailed Description

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The broad goal of this proposal is to determine the effect of aging on areas of the brain whose function is impacted by gonadal steroids in women. The overarching hypothesis is that aging differentially alters the effects of estrogen on the brain. Our preliminary data indicated that aging alters the effect of estrogen on brain regions involved in cognition and thus, the current study focused on the impact of aging on functional changes induced by estrogen in cortical and subcortical areas associated with verbal working memory and declarative/episodic memory.

As our model, we will use women in whom the absence of gonadal function makes it possible to control the duration and amount of estrogen exposure, specifically postmenopausal women who are younger (45-55) or older (65-80) who receive either oral or transdermal estradiol to achieve premenopausal early follicular phase estradiol levels.. We evaluate the effects of low dose estrogen exposure at 48 hr and 1 month to determine whether the short-term changes in brain regions involved in cognition with low dose estrogen exposure seen in our preliminary studies are confirmed and whether changes with short-term estrogen exposure persist with more prolonged exposure, a finding that would have enormous clinical relevance. These studies, using sophisticated neuroimaging tools (structural and functional magnetic resonance imaging \[MRI\] and \[18F\] 2-fluoro-2-deoxy-D-glucose positron emission tomography \[FDG-PET\]), provide a unique window into the brain in women.

Conditions

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Memory Loss Cognitive Changes Postmenopausal Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Each participant was randomized to placebo or estrogen using a block randomized design by age group

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Randomization was performed by the Research Pharmacy and the investigative team was blinded.

Study Groups

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Young postmenopausal women - estrogen

transdermal estrogen patch OR estradiol oral capsule for 1 month

Group Type EXPERIMENTAL

Estradiol oral capsule

Intervention Type DRUG

1 oral capsule (1 mg estradiol) administered daily for one month

transderman estrogen patch

Intervention Type DRUG

transdermal estrogen patch (50 mcg/day) for one month

Older postmenopausal women - estrogen

transdermal estrogen patch OR estradiol oral capsule for 1 month

Group Type EXPERIMENTAL

Estradiol oral capsule

Intervention Type DRUG

1 oral capsule (1 mg estradiol) administered daily for one month

transderman estrogen patch

Intervention Type DRUG

transdermal estrogen patch (50 mcg/day) for one month

Young postmenopausal women - placebo

transdermal placebo patch for 1 month or placebo oral capsule for 1 month

Group Type PLACEBO_COMPARATOR

trasdermal placebo patch

Intervention Type DRUG

transdermal placebo patch with patch change every 84 hr for one month

placebo oral capsule

Intervention Type DRUG

placebo oral capsule administered daily for one month.

Older postmenopausal women - placebo

transdermal placebo patch for 1 month or placebo oral capsule for 1 month

Group Type PLACEBO_COMPARATOR

trasdermal placebo patch

Intervention Type DRUG

transdermal placebo patch with patch change every 84 hr for one month

placebo oral capsule

Intervention Type DRUG

placebo oral capsule administered daily for one month.

Interventions

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Estradiol oral capsule

1 oral capsule (1 mg estradiol) administered daily for one month

Intervention Type DRUG

transderman estrogen patch

transdermal estrogen patch (50 mcg/day) for one month

Intervention Type DRUG

trasdermal placebo patch

transdermal placebo patch with patch change every 84 hr for one month

Intervention Type DRUG

placebo oral capsule

placebo oral capsule administered daily for one month.

Intervention Type DRUG

Other Intervention Names

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Micronized Estradiol Estradiol Climara Estraderm Estrogen patch Placebo patch Placebo capsule

Eligibility Criteria

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Inclusion Criteria

1. young postmenopausal (age 45-55) or older (age 65-80) postmenopausal women
2. otherwise healthy, non-obese women with normal blood pressure and a history of normal menopause, defined by the absence of menses for at least 12 months
3. prescription hormone replacement treatment discontinued at least 3 months before study
4. Normal or corrected normal vision
5. Intelligence quotient (IQ) \> 70 on the Wechsler Adult Reading Test (WTAR)\*
6. Absence of Mild Cognitive Impairment (MCI) and depression on the Mini Mental State Examination (MMSE)\*\* and Beck Depression Inventory II (BDI-II).\*\*\*
7. Normal mammogram or breast MRI within the past 2 years

Exclusion Criteria

1. On gonadal hormone replacement medication, herbal supplements and/or over the counter menopause treatment within three months of study
2. History of radiotherapy or chemotherapy.
3. Absolute contraindications to the use of physiologic replacement doses of estrogen and/or history of coronary artery disease
4. History of breast cancer, blood clot, pulmonary embolus, hypercoagulability and stroke.
5. On centrally acting medications
6. History of head trauma and/or neurologic disorder
7. Contraindication to MRI (eg. metal implants) or PET imaging (eg. PET imaging studies in the previous 12 months)
8. Concurrent participation in research studies involving medications and/or PET scans.
9. Left handedness.
10. Current breast lump(s) or family/genetic history of breast cancer in younger women (\< 40 years old).
11. Current smoking

Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes