Early Menopause Hormone Treatment and Cognition - NCT01046643-48109 (Clinical Trial 464722)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy464722.aspx
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| City: |
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Ann Arbor |
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State:
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MI |
| Zip Code: |
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48109 |
| Conditions: |
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Postmenopausal |
| Purpose: |
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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.
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| Study summary: |
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Specific Aims
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. |
| Criteria: |
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Inclusion Criteria:
- Postmenopausal women
- Ages 45-55, 12 - 24 months from their last menstrual period.
Exclusion Criteria:
- Left handedness
- Acute medical illness
- Neurologic illness
- Psychiatric illness
- Heart disease
- Thromboembolic disease
- Liver disease
- Uncorrected thyroid disease
- Diabetes
- Neurological disease
- Porphyria
- Allergy to estradiol
- Progesterone or lactose
- Lactose intolerance
- Claustrophobia
- Contraindications to MRI (including pacemakers, surgical clips or metallic surgical
devices)
- Surgical menopause
- Smoking within the last 3 years
- Use of hormones within the last 3 months
- Current or past history of substance abuse
- History of head injury or loss of consciousness
- Medications with actions on the central nervous system
- Endometrial lining greater than 5mm
- Ovarian pathology on ultrasound
- Abnormal mammogram
- Migraines
- Fasting cholesterol >300 mg/dl, and fasting triglycerides >300 mg/dl.
- Subjects with HAM-D score > 8, HAM-A > 6 during screening will not be eligible. |
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| Study is available at: |
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University of Michigan Medical Center
Ann Arbor, MI 48109
United States
Primary Contact:
Anne Tkaczyk, M.S.
Email: tkaczyk@umich.edu
Phone: 734-647-7266
Secondary Contact:
Anne Tkaczyk, M.S.
Email: tkaczyk@umich.edu
Phone: 734-647-7266 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 17, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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