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Memory Loss | Aging and Estrogen on Cortical Function

Memory Loss research study

What is the primary objective of this study?

This study will focus on how estrogen affects parts of the brain associated with memory and how the effect of estrogen is altered with aging in postmenopausal women.

Who is eligible to participate?

Inclusion Criteria: 1. young postmenopausal (age 45-55) or older (age 65-80) postmenopausal women 2. otherwise healthy, non-obese women with normal blood pressure and a history of normal menopause, defined by the absence of menses for at least 12 months 3. prescription hormone replacement treatment discontinued at least 3 months before study 4. Normal or corrected normal vision 5. Intelligence quotient (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 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). 11. Current smoking

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Memory Loss

Cognitive Changes

Postmenopausal Symptoms

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Estradiol oral capsule1 oral capsule (1 mg estradiol) administered daily for one month

Drug:transderman estrogen patchtransdermal estrogen patch (50 mcg/day) for one month

Drug:trasdermal placebo patchtransdermal placebo patch with patch change every 84 hr for one month

Drug:placebo oral capsuleplacebo oral capsule administered daily for one month.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Young postmenopausal women - estrogentransdermal estrogen patch OR estradiol oral capsule for 1 month

Older postmenopausal women - estrogentransdermal estrogen patch OR estradiol oral capsule for 1 month

Young postmenopausal women - placebotransdermal placebo patch for 1 month or placebo oral capsule for 1 month

Older postmenopausal women - placebotransdermal placebo patch for 1 month or placebo oral capsule for 1 month

Study Status

Completed

Start Date: November 2009

Completed Date: December 2, 2013

Phase: Phase 1/Phase 2

Type: Interventional

Design:

Primary Outcome: Functional Magnetic Resonance Imaging (fMRI) Changes in Response to Estrogen and Aging - Dorsolateral Pre-frontal Cortex (DLPFC)

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Janet E Hall, MD

Lead Sponsor: Massachusetts General Hospital

Collaborator: National Institute on Aging (NIA)

More information:https://clinicaltrials.gov/show/NCT01268046

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