NCT03821857

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
614

participants targeted

Target at P75+ for phase_4 alzheimer-disease

Timeline
48mo left

Started Jun 2019

Longer than P75 for phase_4 alzheimer-disease

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Jun 2019May 2030

First Submitted

Initial submission to the registry

January 25, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

June 27, 2019

Completed
10.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2030

Last Updated

November 24, 2025

Status Verified

November 1, 2025

Enrollment Period

10.9 years

First QC Date

January 25, 2019

Last Update Submit

November 19, 2025

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Women

EXPERIMENTAL

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

Interventions

18-F-FlortaucipirDRUG

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

Also known as: 11C-Pittsburgh Compound-B
Women

Eligibility Criteria

Age60 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic

Jacksonville, Florida, 32224, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

ENROLLING BY INVITATION

MeSH Terms

Conditions

Alzheimer Disease

Interventions

7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Kejal Kantarci, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

June Kendall-Thomas, CRC

CONTACT

507-293-9397kendallthomas.june15@mayo.edu

Desirae Howe-Clayton, CRC

CONTACT

507-255-0111howe.desirae@mayo.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 25, 2019

First Posted

January 30, 2019

Study Start

June 27, 2019

Primary Completion (Estimated)

May 1, 2030

Study Completion (Estimated)

May 1, 2030

Last Updated

November 24, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(2)