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ACTIVE NOT RECRUITING Phase 2

PhytoSERM to Prevent Menopause Associated Decline in Brain Metabolism and Cognition

NCT05664477 · View on ClinicalTrials.gov ↗

Study Summary

This is a proof-of-concept phase 2 clinical trial to investigate the safety and effect of the phytoestrogenic supplement PhytoSERM on regional brain metabolism by fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET) in peri- and postmenopausal women. The investigators hypothesize that there will be a significant difference between the PhytoSERM group and placebo group in glucose brain metabolism.

Interventions

  • DRUG Placebo
  • DIETARY_SUPPLEMENT PhytoSERM

Study Locations (2)

Arizona

  • University of Arizona / Clinical & Translational Sciences Research Center (CATS — Tucson

New York

  • The Alzheimer's Prevention Program / Weill Cornell Medicine — New York

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2024-01-10
Est. Completion 2027-01-31
Phase Phase 2

Sponsor

Roberta Brinton

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05664477

The ClinicalTrials.gov registry entry for NCT05664477 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Roberta Brinton, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Menopause appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05664477 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Arizona, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05664477 about?

NCT05664477 is a clinical study titled "PhytoSERM to Prevent Menopause Associated Decline in Brain Metabolism and Cognition". This is a proof-of-concept phase 2 clinical trial to investigate the safety and effect of the phytoestrogenic supplement PhytoSERM on regional brain metabolism by fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET) in peri- and postmenopausal women. The investigators hypothesiz...

What is the current status of trial NCT05664477?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2024-01-10. Estimated completion is 2027-01-31.

What conditions does trial NCT05664477 study?

This clinical trial studies the following conditions: Menopause, Cognitive Change, Brain Disorder, Metabolic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05664477?

The interventions under investigation include: Placebo (DRUG), PhytoSERM (DIETARY_SUPPLEMENT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05664477?

This trial is sponsored by Roberta Brinton, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05664477 being conducted?

This trial has 2 study locations across Arizona, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial