RECRUITING

PhytoSERM to Prevent Menopause Associated Decline in Brain Metabolism and Cognition

Conditions

Menopause Cognitive Change Brain Disorder, Metabolic

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-01-10

Study Completion:2028-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05664477

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Study Contact

Claudia M Lopez, BS

CONTACT

5206266276

claudiml@arizona.edu

Principal Investigator

Roberta D Brinton, PhD

PRINCIPAL_INVESTIGATOR

University of Arizona

Gerson D Hernandez, MD, MPH

PRINCIPAL_INVESTIGATOR

University of Arizona

Study Locations (Sites)

The Alzheimer's Prevention Program / Weill Cornell Medicine

New York, New York, 10021

United States

Collaborators and Investigators

Sponsor: Roberta Brinton

Roberta D Brinton, PhD, PRINCIPAL_INVESTIGATOR, University of Arizona
Gerson D Hernandez, MD, MPH, PRINCIPAL_INVESTIGATOR, University of Arizona

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-10

Study Completion Date2028-02-28

Study Record Updates

Study Start Date2024-01-10

Study Completion Date2028-02-28

Terms related to this study

Additional Relevant MeSH Terms

Menopause
Cognitive Change
Brain Disorder, Metabolic