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.

Study Overview

• Status: Active, not recruiting
• Conditions: Alzheimer Disease
• Intervention / Treatment: Drug: 18-F-Flortaucipir

Detailed Description

The proposed project will enroll 200 women. Each women will have one clinic visit 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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Sarah Amundson; Phone Number: 507-422-4692; Email: amundson.sarah@mayo.edu
• Study Contact Backup: Name: Shannin Renn

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Women who lived in Olmsted County, Minnesota between 1988 and 2007
• Currently aged 55 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, 2024
• Study Completion (Estimated): May 1, 2024

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): June 6, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Anti-Inflammatory Agents; Corticosterone
• Other Study ID Numbers: 18-008476; U54AG044170-09 (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