Sex-Specific Effects of Endocrine Disruption on Aging and Alzheimer's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 18-F-Flortaucipir.
- Who it may be relevant to
- Registry conditions: Alzheimer Disease. Basic parameters: from 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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 a total of 614 women.
Mayo Clinic Rochester Participants: Each women will have 2-3 clinic visits 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. All participants will have previously participated and will return by invitation only.
Mayo Clinic Jacksonville Participant: Only African American Women will be enrolled at this site. Each women will have 1-3 clinic visits consisting of physical function testing and 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.
Interventions
- Drug 18-F-Flortaucipir
Radioligands for PET imaging of beta-amyloid and neurofibrillary tangle tau pathology
Primary outcome measures
- 18F-Flortaucipir PET imaging [Time frame: 1 day]
- Pittsburgh compound-B PET imaging [Time frame: 1 day]
Eligibility criteria
Mayo Clinic Rochester-
Inclusion criteria
- Women who previously participated in this study
- Currently aged 60 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
Mayo Clinic Jacksonville-
Inclusion criteria
- African American Women
- Currently aged 60 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 2 centers
- Mayo Clinic — Jacksonville
- Mayo Clinic — Rochester
Publications
- Kantarci K, Kapoor E, Geske JR, Castillo A, Fields JA, Kara F, Knyazhanskaya EE, Schwarz CG, Senjem ML, Bailey KR, Lowe V, LeBrasseur NK, Rocca WA, Mielke MM. Premenopausal bilateral oophorectomy and Alzheimer's disease imaging biomarkers later in life. Alzheimers Dement. 2025 Jul;21(7):e14469. doi: 10.1002/alz.14469. Epub 2024 Dec 23. PMID 39711285
Identifiers
NCT: NCT03821857 · 18-008476 · U54AG044170-09 · R01AG093767