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

Primary Purpose

Alzheimer Disease

Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
18-F-Flortaucipir
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer Disease

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Women

Arm Description

18F-Flortaucipir and 11C-Pittsburgh compound-B radioligands will be used for experimental PET imaging of beta-amyloid and neurofibrillary tau pathology

Outcomes

Primary Outcome Measures

18F-Flortaucipir PET imaging
Cortical 18F-Flortaucipir PET imaging measured once in each participant
Pittsburgh compound-B PET imaging
Global cortical SUVR measured once in each participant

Secondary Outcome Measures

Full Information

First Posted
January 25, 2019
Last Updated
June 5, 2023
Sponsor
Mayo Clinic
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT03821857
Brief Title
Sex-Specific Effects of Endocrine Disruption on Aging and Alzheimer's Disease
Official Title
Sex-Specific Effects of Endocrine Disruption on Aging and Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 27, 2019 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Women
Arm Type
Experimental
Arm Description
18F-Flortaucipir and 11C-Pittsburgh compound-B radioligands will be used for experimental PET imaging of beta-amyloid and neurofibrillary tau pathology
Intervention Type
Drug
Intervention Name(s)
18-F-Flortaucipir
Other Intervention Name(s)
11C-Pittsburgh Compound-B
Intervention Description
Radioligands for PET imaging of beta-amyloid and neurofibrillary tangle tau pathology
Primary Outcome Measure Information:
Title
18F-Flortaucipir PET imaging
Description
Cortical 18F-Flortaucipir PET imaging measured once in each participant
Time Frame
1 day
Title
Pittsburgh compound-B PET imaging
Description
Global cortical SUVR measured once in each participant
Time Frame
1 day

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kejal Kantarci, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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