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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03821857
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Michelle M. Mielke, PhD, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE January 25, 2019
First Posted Date  ICMJE January 30, 2019
Last Update Posted Date October 14, 2019
Actual Study Start Date  ICMJE June 27, 2019
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2019)
  • 18F-Flortaucipir PET imaging [ Time Frame: 1 day ]
    Cortical 18F-Flortaucipir PET imaging measured once in each participant
  • Pittsburgh compound-B PET imaging [ Time Frame: 1 day ]
    Global cortical SUVR measured once in each participant
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sex-Specific Effects of Endocrine Disruption on Aging and Alzheimer's Disease
Official Title  ICMJE Sex-Specific Effects of Endocrine Disruption on Aging and Alzheimer's Disease
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE Diagnostic Test: 18-F-Flortaucipir
Radioligands for PET imaging of beta-amyloid and neurofibrillary tangle tau pathology
Other Name: 11C-Pittsburgh Compound-B
Study Arms  ICMJE Experimental: Women
18F-Flortaucipir and 11C-Pittsburgh compound-B radioligands will be used for experimental PET imaging of beta-amyloid and neurofibrillary tau pathology
Intervention: Diagnostic Test: 18-F-Flortaucipir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 28, 2019)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2023
Estimated Primary Completion Date March 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sarah Amundson 507-422-4692 amundson.sarah@mayo.edu
Contact: Shannin Renn
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03821857
Other Study ID Numbers  ICMJE 18-008476
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Michelle M. Mielke, PhD, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michelle Mielke, PhD Mayo Clinic
PRS Account Mayo Clinic
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP