How women's ovarian hormone changes relate to aging and Alzheimer's disease risk
Sex-Specific Effects of Endocrine Disruption on Aging and Alzheimer's Disease
PHASE4 · Mayo Clinic · NCT03821857
This project will test if changes in ovarian hormones in women aged 60 and older are linked to aging signs and Alzheimer's-related brain changes.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 614 (estimated) |
| Ages | 60 Years and up |
| Sex | Female |
| Sponsor | Mayo Clinic (other) |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Jacksonville, Florida and 1 other locations) |
| Trial ID | NCT03821857 on ClinicalTrials.gov |
What this trial studies
The study will enroll about 614 women previously enrolled in the parent cohort and will use clinic visits, blood draws, cognitive and physical testing, and questionnaires to capture clinical and functional measures. All participants will undergo structural MRI and PET imaging for β-amyloid and tau (using 18F-AV-1451/flortaucipir) to measure Alzheimer-related brain pathology. The Rochester site will include participants returning by invitation with 2–3 visits including cognitive testing, while the Jacksonville site will enroll only African American women with 1–3 visits focused on function and neuroimaging. Eligibility requires being age 60 or older, more than six months since chemotherapy or major surgery requiring general anesthesia, ability to consent, and the ability to undergo MRI/PET procedures.
Who should consider this trial
Good fit: Ideal candidates are women aged 60 or older from the original cohort who are more than six months post-chemotherapy or major surgery, can undergo MRI/PET and clinical testing, and (for Jacksonville) are African American.
Not a fit: Men, younger women, people unable to undergo MRI/PET (for example due to claustrophobia or certain cardiac contraindications), those in hospice, or those who cannot read and speak English are not eligible and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could identify hormone-related biomarkers or pathways that improve prediction of Alzheimer's risk in women and guide sex-specific prevention strategies.
How similar studies have performed: Previous studies have reported associations between reproductive hormones and brain aging and some PET studies have linked hormone-related factors to Alzheimer pathology, but causal sex-specific mechanisms remain uncertain.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Jacksonville, Florida and 1 other locations
- Mayo Clinic — Jacksonville, Florida, United States (RECRUITING)
- Mayo Clinic — Rochester, Minnesota, United States (ENROLLING_BY_INVITATION)
Study contacts
- Principal investigator: Kejal Kantarci, MD — Mayo Clinic
- Study coordinator: June Kendall-Thomas, CRC
- Email: kendallthomas.june15@mayo.edu
- Phone: 507-293-9397
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Alzheimer Disease