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

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ClinicalTrials.gov Identifier: NCT03821857
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Michelle M. Mielke, PhD, Mayo Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Diagnostic Test: 18-F-Flortaucipir Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Sex-Specific Effects of Endocrine Disruption on Aging and Alzheimer's Disease
Actual Study Start Date : June 27, 2019
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
 Diagnostic Test: 18-F-Flortaucipir
Radioligands for PET imaging of beta-amyloid and neurofibrillary tangle tau pathology
Other Name: 11C-Pittsburgh Compound-B


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821857


Contacts
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Contact: Sarah Amundson 507-422-4692 amundson.sarah@mayo.edu
Contact: Shannin Renn

Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Sarah Amundson    507-422-5627    amundson.sarah@mayo.edu   
Principal Investigator: Michelle M Mielke, PhD         
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Michelle Mielke, PhD Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Michelle M. Mielke, PhD, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03821857    
Other Study ID Numbers: 18-008476
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
 Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Corticosterone
Anti-Inflammatory Agents