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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
December 28, 2010
March 17, 2017
November 2009
October 2018   (Final data collection date for primary outcome measure)
Neuroimaging changes in response to estrogen [ Time Frame: 48 hrs and 28-30 days ]
Neuroimaging changes in response to estrogen [ Time Frame: 48 hrs and 30 days ]
Complete list of historical versions of study NCT01268046 on ClinicalTrials.gov Archive Site
Neuropsychological testing changes in response to receiving estradiol [ Time Frame: 48 hrs and 28-30 days ]
Neuropsychological testing changes in response to receiving estradiol [ Time Frame: 48 hrs and 30 days ]
Not Provided
Not Provided
 
Effects of Aging and Estrogen on Memory and Cognition
Effects of Aging and Estrogen on Cortical Function
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.
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.
Interventional
Phase 4
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
  • Memory Loss
  • Cognitive Changes
  • Postmenopausal Symptoms
  • 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 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.
    Interventions:
    • Drug: Estradiol
    • Drug: Placebo oral capsule
  • 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.
    Interventions:
    • Drug: Estradiol
    • Drug: Placebo oral capsule
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
October 2018
October 2018   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: Female
18 Years to 80 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01268046
2009P-002311
R01AG013241 ( U.S. NIH Grant/Contract )
Yes
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
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.
Janet E. Hall, MD, Massachusetts General Hospital
Massachusetts General Hospital
National Institute on Aging (NIA)
Principal Investigator: Janet E Hall, MD Massachusetts General Hospital
Massachusetts General Hospital
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP