Phase 2
Completed N=38
Aging and Estrogen on Cortical Function
Memory Loss · Cognitive Changes · Postmenopausal Symptoms
Source: ClinicalTrials.gov NCT01268046 ↗
Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcomePrimary: Functional Magnetic Resonance Imaging (fMRI) Changes in Response to Estrogen and Aging - Dorsolateral Pre-frontal Cortex (DLPFC) — 455.8; -214.4; -348.1; 90.1 linear beta extractions
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Functional Magnetic Resonance Imaging (fMRI) Changes in Response to Estrogen and Aging - Dorsolateral Pre-frontal Cortex (DLPFC) |
455.8; -214.4; -348.1; 90.1 | — |
Eligibility Criteria
Inclusion Criteria
- young postmenopausal (age 45-55) or older (age 65-80) postmenopausal women
- 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
- prescription hormone replacement treatment discontinued at least 3 months before study
- Normal or corrected normal vision
- Intelligence quotient (IQ) > 70 on the Wechsler Adult Reading Test (WTAR)*
- Absence of Mild Cognitive Impairment (MCI) and depression on the Mini Mental State Examination (MMSE)** and Beck Depression Inventory II (BDI-II).***
- Normal mammogram or breast MRI within the past 2 years
Exclusion Criteria
- On gonadal hormone replacement medication, herbal supplements and/or over the counter menopause treatment within three months of study
- History of radiotherapy or chemotherapy.
- Absolute contraindications to the use of physiologic replacement doses of estrogen and/or history of coronary artery disease
- History of breast cancer, blood clot, pulmonary embolus, hypercoagulability and stroke.
- On centrally acting medications
- History of head trauma and/or neurologic disorder
- Contraindication to MRI (eg. metal implants) or PET imaging (eg. PET imaging studies in the previous 12 months)
- Concurrent participation in research studies involving medications and/or PET scans.
- Left handedness.
- Current breast lump(s) or family/genetic history of breast cancer in younger women (< 40 years old).
- Current smoking
Data sourced from ClinicalTrials.gov (NCT01268046). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.