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Recruiting

NCT Number: NCT03821857

Sex-Specific Effects of Endocrine Disruption on Aging and Alzheimer's Disease

The researchers are trying to determine whether ovarian hormones are associated with aging processes and with the risk of developing Alzheimer's disease in women.

Recruiting

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Key information

Age range

60 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic, Jacksonville, Florida, United States

Loading trial locations.

About this study

The proposed project will enroll a total of 614 women.

Mayo Clinic Rochester Participants: Each women will have 2-3 clinic visits consisting of cognitive testing, tests of physical function, questionnaires, and a blood draw. All women will also undergo clinical neuroimaging, which includes structural MRI, β-amyloid (Aβ) deposition on PET as a biomarker of Aβ pathology, and tau deposition on PET as a marker of neurofibrillary tangles using AV-1451. All participants will have previously participated and will return by invitation only.

Mayo Clinic Jacksonville Participant: Only African American Women will be enrolled at this site. Each women will have 1-3 clinic visits consisting of physical function testing and neuroimaging, which includes structural MRI, β-amyloid (Aβ) deposition on PET as a biomarker of Aβ pathology, and tau deposition on PET as a marker of neurofibrillary tangles using AV-1451.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Mayo Clinic Rochester-

Inclusion criteria

  • Women who previously participated in this study
  • Currently aged 60 years and older
  • More than six months post chemotherapy or major surgery requiring general anesthesia
  • Willing and able to sign informed consent

Exclusion criteria

  • Not able to read and speak English
  • In hospice
  • Claustrophobic
  • If undergoing Tau imaging, cannot have QT Prolongation

Mayo Clinic Jacksonville-

Inclusion criteria

  • African American Women
  • Currently aged 60 years and older
  • More than six months post chemotherapy or major surgery requiring general anesthesia
  • Willing and able to sign informed consent

Exclusion criteria

  • Not able to read and speak English
  • In hospice
  • Claustrophobic
  • If undergoing Tau imaging, cannot have QT Prolongation

Treatment and study plan

18-F-Flortaucipir

Drug

Radioligands for PET imaging of beta-amyloid and neurofibrillary tangle tau pathology

Other names: 11C-Pittsburgh Compound-B

Primary outcomes

  1. 18F-Flortaucipir PET imaging

    Time frame: 1 day

    Cortical 18F-Flortaucipir PET imaging measured once in each participant

  2. Pittsburgh compound-B PET imaging

    Time frame: 1 day

    Global cortical SUVR measured once in each participant

Study contacts

Contact information is provided by the study sponsor or research team.

Desirae Howe-Clayton, CRC

CONTACT

[email protected]

507-255-0111

June Kendall-Thomas, CRC

CONTACT

[email protected]

507-293-9397

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: SEED-AD

Important dates

Study start
2019
Primary completion
2030
Study completion
2030
First posted
Jan 30, 2019
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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