Sex-Specific Effects of Endocrine Disruption on Aging and Alzheimer's Disease (SEED-AD)

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.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer Disease
• Intervention / Treatment: Drug: 18-F-Flortaucipir

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 614
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: June Kendall-Thomas, CRC; Phone Number: 507-293-9397; Email: kendallthomas.june15@mayo.edu
• Study Contact Backup: Name: Desirae Howe-Clayton, CRC; Phone Number: 507-255-0111; Email: howe.desirae@mayo.edu

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic
      • Principal Investigator: Neill Graff-Radford, MD
      • Contact: Twilla Morrell, CRC; Phone Number: 904-953-3420; Email: morrell.twila@mayo.edu
      • Contact: Ercilia Moncayo, CRC; Phone Number: 904-953-3308; Email: moncayo.ercilia@mayo.edu
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Enrolling by invitation
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Women; 18F-Flortaucipir and 11C-Pittsburgh compound-B radioligands will be used for experimental PET imaging of beta-amyloid and neurofibrillary tau pathology	Drug: 18-F-Flortaucipir; Radioligands for PET imaging of beta-amyloid and neurofibrillary tangle tau pathology; Other Names: 11C-Pittsburgh Compound-B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
18F-Flortaucipir PET imaging	Cortical 18F-Flortaucipir PET imaging measured once in each participant	1 day
Pittsburgh compound-B PET imaging	Global cortical SUVR measured once in each participant	1 day

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Kejal Kantarci, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2019
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030

Study Registration Dates

• First Submitted: January 25, 2019
• First Submitted That Met QC Criteria: January 28, 2019
• First Posted (Actual): January 30, 2019

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 19, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease; Anti-Inflammatory Agents; 7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole; 2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole
• Other Study ID Numbers: 18-008476; U54AG044170-09 (U.S. NIH Grant/Contract); R01AG093767 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No