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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 : Not yet recruiting
First Posted : January 30, 2019
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Michelle M. Mielke, Mayo Clinic

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
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
Estimated Study Start Date : June 2019
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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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

Additional Information:
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Responsible Party: Michelle M. Mielke, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03821857     History of Changes
Other Study ID Numbers: 18-008476
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
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