PhytoSERM to Prevent Menopause Associated Decline in Brain Metabolism and Cognition

Exclusion Criteria

• •1. Known allergies to isoflavones or soy-based products.
• •2. Evidence of cognitive impairment on the Mini-Mental State Examination (total score \< 27).
• •3. Pregnancy
• •4. Use of estrogen or progestin compounds within 8 weeks of baseline.
• •5. Use of investigational agent within 12 weeks of baseline.
• •6. Concurrent neurologic, systemic, or psychiatric disease that would influence cognition or ability to provide informed consent and to participate.
• •7. Known or suspected estrogen-dependent neoplasia, active neoplastic disease, history of breast cancer, or at risk of developing breast cancer, endometrial hyperplasia.
• •8. History of epilepsy, focal brain lesion, head injury with loss of consciousness or Diagnostic and Statistical Manual of Mental Disorders (DSM IV) criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse.
• •9. Thrombophlebitis, thrombosis, thromboembolic disorders, myocardial infarction, ischemic heart disease, cerebrovascular accident, stroke, transient ischemic attack (TIA).
• •10. Current use of tobacco or a history of alcohol abuse.
• •11. Use of drugs, herbs, or dietary supplements to treat menopausal or cognitive symptoms less than 8 weeks prior to baseline.
• •12. Evidence of any significant clinical disorder or laboratory finding.
• •13. Known allergy to soy-derived products/ proteins or branded over the counter products; hypersensitivity to estrogens or progestins.
• •14. Visual and auditory acuity inadequate for neuropsychological testing
• •15. Inability to undergo MRI scans
• •16. Inability to undergo PET scans