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NCT03821857 Clinical Trial

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

Alzheimer Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03821857
Other study ID # 18-008476
Secondary ID U54AG044170-09
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date June 27, 2019
Est. completion date May 2025

Study information
Verified date June 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 200
Est. completion date May 2025
Est. primary completion date May 2025
Accepts healthy volunteers No
Gender Female
Age group 55 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 18-F-Flortaucipir
Radioligands for PET imaging of beta-amyloid and neurofibrillary tangle tau pathology

Locations
Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 18F-Flortaucipir PET imaging Cortical 18F-Flortaucipir PET imaging measured once in each participant 1 day
Primary Pittsburgh compound-B PET imaging Global cortical SUVR measured once in each participant 1 day
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