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New supplement aims to shield menopausal brains from cognitive decline

NCT ID NCT05664477

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

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

45 to 60 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

Brain Diseases, Metabolic cognitive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • The Alzheimer's Prevention Program / Weill Cornell Medicine

    New York, New York, 10021, United States

  • 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.