View Clinical Trial (Medical Research Study)


Effects of Aging and Estrogen on Cortical Function

Signup
Browse Studies

City:   Boston
State:   Massachusetts
Zip Code:   02114
Conditions:   Memory Loss - Cognitive Changes - Postmenopausal Symptoms
Purpose:   This study will focus on how aging affects changes in the way the brain works when affected by estrogen in areas of the brain associated with memory.
Study Summary:   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 indicate that aging alters the effect of estrogen on brain regions involved in cognition and thus, the current proposal will focus 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 young women with Premature Ovarian Insufficiency (POI) < 45 yrs. old (but diagnosed at < 40 yrs.) and postmenopausal women who are younger (45-55) or older (65-80). We will investigate the effects of both short-term (48 hr) and prolonged (28-30 days) estrogen exposure to determine whether the changes in brain regions involved in cognition that were seen with short-term estrogen exposure persist with 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 the human.
Criteria:   Inclusion Criteria 1. Three groups of menopausal women will be recruited for these studies: - young (age 45-55) - older (age65-80) postmenopausal women (PMW) - women with Premature Ovarian Insufficiency (POI) < 45 yrs. old (but diagnosed at < 40 yrs.) 2. The subjects will be otherwise healthy, non-obese women, normotensive and non-smokers 3. History of normal menopause, defined by the absence of menses for at least 12 months 4. Subjects with premature menopause will have had: - menarche between the ages of 10 and 15 - regular menstrual cycles before the onset of ovarian failure at < 35 - at least 1 year of amenorrhea before study or no unscheduled menses while on HRT (discontinued at least 3 months before study, as above) - have normal adrenal function and not be carriers for the Fragile X premutation 5. FSH > 26 IU/L (2nd IRP HMG) and E2 < 25 pg/mL at screening and on the initial day of study and normal TSH, and Factor V activity 6. Normal or corrected normal vision 7. IQ > 70 on the Wechsler Adult Reading Test (WTAR)* 8. Absence of Mild Cognitive Impairment (MCI) and depression on the Mini Mental State Examination (MMSE)** and Beck Depression Inventory II (BDI-II).*** 9. Normal mammogram or breast MRI within the past 2 years (age 45 and older only). Exclusion Criteria 1. On gonadal hormone replacement medication, herbal supplements and/or over the counter menopause treatment for 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).
NCT ID:   NCT01268046
Primary Contact:   Principal Investigator
Janet E Hall, MD
Massachusetts General Hospital

Taylor A Huhta, BA
Phone: 617-726-5384
Email: thuhta@partners.org
Backup Contact:   N/A
Location Contact:   Boston, Massachusetts 02114
United States



There is no listed contact information for this specific location.

Site Status: Recruiting

Data Source:   ClinicalTrials.gov
Date Processed:   April 24, 2014
Modifications to this listing:   Only selected fields are shown, please use the link below to view all information about this clinical trial.
Click to view Full Listing


If you would like to be contacted by the clinical trial representative please enter your contact information, then click "I Am Interested In This Study"
First Name:  
Last Name:  
Email Address:  
Confirm Email:    
Daytime Phone (eg. 555-555-5555):  
City:  
State:
Zip Code:    
Best Time to Call:  
Questions/Comments:  
  • NEARBY STUDIES

Within 25 Miles

Gingivitis - Cambridge MA

Gum Disease - Cambridge MA

Cataracts - Quincy MA

Healthy Volunteers (Weighing less than 175 lbs) - Boston MA

Healthy Volunteers (Weighing more than 175 lbs) - Boston MA

Gout with Heart Conditions - Brockton MA

Obsessive Compulsive Disorder (OCD) - Boston MA

Post Herpatic Neuralgia - Brockton MA

Overactive Bladder - Brockton MA

Constipation - Brockton MA

Adolescent Major Depression (Ages 12-17) - Watertown MA

Glaucoma - Quincy MA

Dust Mite Allergy - Brockton MA

Mild Alzheimer’s Disease - Methuen MA

Cancer Pain - Chestnut Hill MA

Mild Alzheimer’s Disease - Brockton MA

Postherpetic Neuralgia (Post-Shingles Pain) - Boston MA

Osteoarthritis of Knee - Brockton MA

Diabetic Neuropathy - Brockton MA

Opioid Induced Constipation - Brockton MA

High Cholesterol - Brockton MA

Acne - Brockton MA

Mild Alzheimer’s Disease - Boston MA

Irritable Bowel Syndrome with Diarrhea - Brockton MA

Smoking Cessation (Teens Ages 12 - Watertown MA

Leukemia and Lymphoma - Boston MA

Myelofibrosis - Boston MA

Low Back Pain and Constipation - Brockton MA

High Cholesterol - Brockton MA

Alzheimer's Disease - Brockton MA

Treatment Resistant Depression - Boston MA

Migraines - Brockton MA

Mild Alzheimer’s Disease - Boston MA

Within 50 Miles

Alzheimer's Disease - East Providence RI

Endometriosis - Providence RI

Endometriosis - Fall River MA

Asthma - Warwick RI

Mild Alzheimer’s Disease - East Providence RI

Asthma - North Dartmouth MA

Type 2 Diabetes - East Providence RI

Type 2 Diabetes - Nashua NH

Within 100 Miles

Multiple Sclerosis - New London CT