Early Menopause Hormone Treatment and Cognition (R21)
The objective of this study is to evaluate the neurobiological effects of hormone therapy (HT) in healthy early postmenopausal women. The studies proposed in this project seek to define the association between different hormone forms (estradiol only and progesterone only) versus placebo on brain functional measures. The functional measures will include the performance of the volunteers on a comprehensive neuropsychological testing battery, and the brain functional responses to episodic memory (verbal and non-verbal) challenges as well as emotional processing determined with fMRI.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Hormones and Cognitive Processing in Early Postmenopausal Women|
- Brain activization patterns determined with the fMRI scans [ Time Frame: August 2010 - March 2012 ] [ Designated as safety issue: No ]The goal of this study is to measure the changes in brain activity with hormone use (either estradiol or progesterone versus placebo).
- Neuropsychological testing [ Time Frame: August 2010 - March 2012 ] [ Designated as safety issue: No ]
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||March 2012|
|Estimated Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Estrogen
Drug: Estradiol (E2)
One Estradiol capsule (1mg) once a day, at the same time each day, for 90 days
Other Name: E2
Active Comparator: Progesterone
Drug: Progesterone (P10)
One Progesterone (200 mg) capsule once a day, at the same time each day, for 90 days
Other Name: P10
Aim 1. To examine the effects of estradiol alone on brain functioning in early post-menopausal women during verbal and non-verbal cognitive tasks.
Hypothesis: It is expected that with estradiol treatment brain activation will be more prominent in the hippocampus and prefrontal cortical areas compared to placebo. The magnitude of activation in these regions will be positively correlated with task performance in the scanner and with the results of neuropsychological tests assessing verbal and non-verbal delayed recall.
Aim 2. To determine the effects of progesterone alone on brain functioning in early postmenopausal women during verbal and non-verbal cognitive tasks.
Hypothesis: It is expected that with progesterone treatment brain activation in the hippocampus and prefrontal cortical areas will be decreased compared to both the placebo condition (within subjects) and the estradiol condition (between subjects). Interindividual variations in the magnitude of activation in these regions will be positively correlated with task performance in the scanner and with the results of neuropsychological tests assessing verbal and non-verbal delayed recall.
Aim 3. To determine the individual effects of estradiol and progesterone on brain functioning in early postmenopausal women during emotional processing stimuli.
Hypothesis: During negative stimuli estradiol-treated women compared to placebo group, are expected to have increased activity in the amygdala, posterior cingulate, and orbitofrontal cortex, while in progesterone-treated women compared to placebo, decreased activity is expected in these brain regions.
|United States, Michigan|
|The University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Yolanda R. Smith, M.D.||University of Michigan|