Sex-Specific Effects of Endocrine Disruption on Aging and Alzheimer's Disease
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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 19, 2020
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Condition or disease | Intervention/treatment | Phase |
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Alzheimer Disease | Diagnostic Test: 18-F-Flortaucipir | Phase 4 |
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 |

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

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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 |
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

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
Contact: Sarah Amundson | 507-422-4692 | amundson.sarah@mayo.edu | |
Contact: Shannin Renn |
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 |
Principal Investigator: | Michelle Mielke, PhD | Mayo Clinic |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies |
Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Corticosterone Anti-Inflammatory Agents |