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Effects of Aging and Estrogen on Memory and Cognition

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Janet E. Hall, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01268046
First received: December 28, 2010
Last updated: March 17, 2017
Last verified: March 2017
  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.

Condition Intervention Phase
Memory Loss Cognitive Changes Postmenopausal Symptoms Drug: Estradiol Drug: Placebo oral capsule Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Study of the effect of placebo capsule and estradiol in young and older postmenopausal women on areas of the brain involved in cognition using PET and fMRI.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Aging and Estrogen on Cortical Function

Resource links provided by NLM:


Further study details as provided by Janet E. Hall, MD, Massachusetts General Hospital:

Primary Outcome Measures:
  • Neuroimaging changes in response to estrogen [ Time Frame: 48 hrs and 28-30 days ]

Secondary Outcome Measures:
  • Neuropsychological testing changes in response to receiving estradiol [ Time Frame: 48 hrs and 28-30 days ]

Estimated Enrollment: 60
Actual Study Start Date: November 2009
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Postmenopausal women 45-55 years old
Healthy women aged 45-55 at least 1 year from final menstrual period receiving 30 days of placebo oral capsule and and 30 days of estradiol (1 mg/day) assessed using fMRI and PET scans.
Drug: Estradiol
1 mg/day for 30 days administered through a capsule
Other Name: Micronized Estradiol from Mylan Pharmaceuticals
Drug: Placebo oral capsule
Administered daily for 30 days.
Other Name: placebo
Experimental: Postmenopausal women 65-80 years old
Healthy women aged 65-80 at least one year from final menstrual period receiving 30 days of placebo oral capsule and 30 days of estradiol (1 mg/day) assessed using fMRI and PET scans.
Drug: Estradiol
1 mg/day for 30 days administered through a capsule
Other Name: Micronized Estradiol from Mylan Pharmaceuticals
Drug: Placebo oral capsule
Administered daily for 30 days.
Other Name: placebo

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 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 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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. young postmenopausal (age 45-55) or older (age 65-80) postmenopausal women
  2. otherwise healthy, non-obese women, normotensive and non-smokers history of normal menopause, defined by the absence of menses for at least 12 months
  3. hormone replacement treatment discontinued at least 3 months before study
  4. Normal or corrected normal vision
  5. 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 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01268046

Locations
United States, Massachusetts
Reproductive Endocrine Unit, Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institute on Aging (NIA)
Investigators
Principal Investigator: Janet E Hall, MD Massachusetts General Hospital
  More Information

Responsible Party: Janet E. Hall, MD, Associate Physician, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01268046     History of Changes
Other Study ID Numbers: 2009P-002311
R01AG013241 ( U.S. NIH Grant/Contract )
Study First Received: December 28, 2010
Last Updated: March 17, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified information will be made available on request to the PI once the primary data analysis has been published.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Janet E. Hall, MD, Massachusetts General Hospital:
aging
postmenopausal women
estrogen
memory

Additional relevant MeSH terms:
Memory Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Estradiol
Polyestradiol phosphate
Estrogens
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol valerate
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on September 25, 2017