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Memory Loss | Effects of Aging and Estrogen on Memory and Cognition

Memory Loss research study

What is the primary objective of this study?

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.

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, 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).

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:Estradiol1 mg/day for 30 days administered through a capsule

Drug:Placebo oral capsuleAdministered daily for 30 days.

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.

Postmenopausal women 45-55 years oldHealthy 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.

Postmenopausal women 65-80 years oldHealthy 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.

Study Status

Active, not recruiting

Start Date: November 2009

Completed Date: October 2018

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Neuroimaging changes in response to estrogen

Secondary Outcome: Neuropsychological testing changes in response to receiving estradiol

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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