Sex-Specific Effects of Endocrine Disruption on Aging and Alzheimer's Disease (SEED-AD)

Mayo Clinic

Status and phase: Enrolling; Phase 4

Conditions: Alzheimer Disease

Treatments: Drug: 18-F-Flortaucipir

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03821857

18-008476

U54AG044170-09 (U.S. NIH Grant/Contract)

R01AG093767 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 614 estimated patients

Sex: Female

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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614 participants in 1 patient group

Women

Experimental group

Description:

18F-Flortaucipir and 11C-Pittsburgh compound-B radioligands will be used for experimental PET imaging of beta-amyloid and neurofibrillary tau pathology

Treatment:

Drug: 18-F-Flortaucipir