PhytoSERM to Prevent Menopause Associated Decline in Brain Metabolism and Cognition

Launched by ROBERTA BRINTON · Dec 22, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a supplement called PhytoSERM to see if it can help improve brain function and metabolism in women going through menopause. Researchers believe that taking this supplement may lead to better brain health by increasing glucose metabolism, which is how the brain uses sugar for energy. The trial is currently looking for women aged 45 to 60 who are either in the peri-menopausal or postmenopausal stages, have frequent hot flashes, and are generally in good health.

Participants in this study will take either PhytoSERM or a placebo (a pill with no active ingredients) and undergo brain scans to measure how well their brain is functioning. To join, women must meet certain criteria, like being in good health and able to take oral medications. It's important to note that women who have certain health conditions, are pregnant, or have a history of particular medical issues may not be eligible. If you qualify and choose to participate, you'll be contributing to research that could help improve the health of women experiencing menopause.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Peri- or postmenopausal women with the latter defined as last menstrual period (LMP) completed ≥ 60 days and ≤ 4 years, per the Stages of Reproductive Aging Workshop (STRAW) criteria.
• • 2. Age 45-60 years.
• • 3. Presence of hot flashes ≥ 7 per day.
• • 4. In good general health as evidenced by medical history.
• • 5. Clinical laboratory values must be within normal limits or, if abnormal, must be judged to be not clinically significant by the investigator.
• • 6. No medical contraindications to study participation.
• • 7. Stable medications for 4 weeks prior to the baseline visits.
• • 8. Provision of signed and dated informed consent form.
• • 9. Stated willingness to comply with all study procedures and availability for the duration of the study.
• • 10. Ability to take oral medication and be willing to adhere to the PhytoSERM regimen.
• • 11. For females of reproductive potential: Negative pregnancy test and use of highly effective contraception by male partner for at least 1 month prior to screening and agreement to use such a method during study participation.
• • 12. Fluent in English or Spanish.
• 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