NIH-funded research R01 grant

PhytoSERM: A brain-friendly estrogen approach to protect cognition in menopausal women

Official title: PhytoSERM Efficacy to Prevent Menopause Associated Decline in Brain Metabolism and Cognition: A Double-Blind, Randomized, Placebo-Controlled Phase 2 Clinical Trial

Funded at University of Arizona · NIH-11300208 · Data updated 2026-11-12

A Phase 2 trial tests a plant-based estrogen modulator to help peri- and postmenopausal women maintain brain metabolism and thinking skills without increasing risk to breast tissue.

More Cognition research and trials

Quick facts

Grant typeR01 grant
Study typeNIH-funded research
Funding institutionUniversity of Arizona
NIH-funded
Lab location1 site (Tucson, United States)
Project startFebruary 15, 2022
Project endJanuary 31, 2027
Funding year2026
Award (this year)$1,353,297
NIH project number5R01AG075122-05
Project IDNIH-11300208 on NIH RePORTER

Who could benefit from this research

Could help

Women in the peri- or postmenopausal stage who are experiencing menopausal symptoms and are at risk for cognitive changes.

Less likely to help

Menopausal women without cognitive symptoms or those not at risk for Alzheimer’s-related changes may not benefit.

What this research studies

This study tests PhytoSERM, a brain-focused estrogen receptor beta modulator, in symptomatic peri- and postmenopausal women. It uses a double‑blind, randomized, placebo-controlled design to see if the drug can preserve brain metabolism and cognitive function during the menopausal transition. Participants will receive PhytoSERM or a placebo over a defined period, with safety and pharmacokinetics closely monitored. The goal is to identify whether this brain-targeted approach can reduce the risk signals associated with Alzheimer’s disease in this at-risk population.

Why it matters

Potential benefit: If successful, PhytoSERM could help protect cognitive health during menopause by supporting brain estrogen action without breast tissue risks.

How similar studies have gone: Prior early-phase work suggested PhytoSERM is safe and tolerable with potential efficacy signals in the target population.

Where this research is happening

  • University of Arizona
    Tucson, United States
    Active

Researchers

  • Principal investigator: Brinton, Roberta Eileen — University of Arizona
  • Study coordinator: Brinton, Roberta Eileen

Related research

Other NIH-funded projects on the same topics.

  • Menopause, aging and brain health: how midlife changes affect Alzheimer’s risk

    This study follows women who were part of a large midlife health study to see how menopause and related factors relate to brain biomarkers and memory later in life.

    NIH research Massachusetts General Hospital · Boston, United States · NIH-11447728

  • Menopause and brain health in aging women

    A long-term study follows women through menopause to see how hormonal changes affect brain structure, function, and thinking.

    NIH research Washington University · Saint Louis, United States · NIH-11321217

  • Investigating a new treatment to prevent cognitive decline in menopausal women.

    This study is looking at whether a new treatment called PhytoSERM can help improve brain health and thinking skills in women going through menopause or who have already gone through it, with the hope of lowering the risk of Alzheimer's disease.

    NIH research University of Arizona · Tucson, United States · NIH-11020972

  • How menopause affects women's brain health and thinking skills

    This study is looking at how menopause affects the brain and thinking skills in women aged 40-59, and it aims to help us understand how changes during this time might influence brain health and the risk of Alzheimer's disease.

    NIH research Washington University · Saint Louis, United States · NIH-10909115

  • Cognition After War: A new {HCAP} for older adults and their children

    A study will create a standardized cognitive test battery for older veterans and their midlife children to understand how early-life war exposure might influence dementia risk.

    NIH research Utah State Higher Education System--University of Utah · Salt Lake City, United States · NIH-11603140

  • Cognition After War: A New, Harmonized Cognitive Check for Older Adults and Their Children

    A new program will create a standardized set of cognitive tests and study how early-life war experiences might raise dementia risk in older adults and potentially affect their midlife children.

    NIH research Utah State Higher Education System--University of Utah · Salt Lake City, United States · NIH-11603139

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.