Conditions: Memory Loss Cognitive Changes Postmenopausal Symptoms
Keywords: aging postmenopausal women estrogen memory
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 38
Healthy volunteers: yes

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: transdermal estrogen patch OR estradiol oral capsule for 1 month arm 2: transdermal estrogen patch OR estradiol oral capsule for 1 month arm 3: transdermal placebo patch for 1 month or placebo oral capsule for 1 month arm 4: transdermal placebo patch for 1 month or placebo oral capsule for 1 month

Interventions: intervention 1: Estradiol oral capsule intervention 2: transderman estrogen patch intervention 3: trasdermal placebo patch intervention 4: placebo oral capsule
Intervention descriptions: intervention 1: 1 oral capsule (1 mg estradiol) administered daily for one month intervention 2: transdermal estrogen patch (50 mcg/day) for one month intervention 3: transdermal placebo patch with patch change every 84 hr for one month intervention 4: placebo oral capsule administered daily for one month.

Protocol document: