New supplement aims to shield menopausal brains from cognitive decline
NCT ID NCT05664477
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a plant-based supplement called PhytoSERM in 100 women aged 45-60 who are in or just past menopause. The goal is to see if it can prevent changes in brain activity and thinking skills that often happen during this time. Participants take either the supplement or a placebo for several months, and researchers measure brain metabolism and memory tests.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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45 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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The Alzheimer's Prevention Program / Weill Cornell Medicine
New York, New York, 10021, United States
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University of Arizona / Clinical & Translational Sciences Research Center (CATS
Tucson, Arizona, 85721, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Two estradiol dosing schedules put brain effects to the test
- Can strength training steady the walk and strengthen the pelvic floor after menopause?
- Can a brazilian diet calm menopause hot flashes?
- Can Omega-3s keep menopausal minds sharp?
- Does hormone therapy for menopause leave a mark on breasts and arteries?
- Can tiny tablets replace protein powder for kids with PKU?