Alzheimer DiseasePhase 4SEED-ADNCT03821857
Sex-Specific Effects of Endocrine Disruption on Aging and Alzheimer's Disease
A Phase 4 study testing 18-F-Flortaucipir in people with Alzheimer Disease, run by Mayo Clinic at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- 18-F-Flortaucipir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 614 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Jun 2019to May 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- Not able to read and speak English
- In hospice
- Claustrophobic
- If undergoing Tau imaging, cannot have QT Prolongation
- Mayo Clinic Jacksonville-
- Not able to read and speak English
Show all 9Show fewer
- In hospice
- Claustrophobic
- If undergoing Tau imaging, cannot have QT Prolongation
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Mayo Clinic
Jacksonville, Florida, 32224
Twilla Morrell, CRC, 904-953-3420, morrell.twila@mayo.edu
Ercilia Moncayo, CRC, 904-953-3308, moncayo.ercilia@mayo.edu
- Enrolling by invitation
Mayo Clinic
Rochester, Minnesota, 55905
About this study
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.
Read the 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.
- Conditions
- Alzheimer Disease
- Being tested
- 18-F-Flortaucipir
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18-F-FlortaucipirDrug
Also called 11C-Pittsburgh Compound-B
Radioligands for PET imaging of beta-amyloid and neurofibrillary tangle tau pathology
| Study group | Role | What they receive |
|---|---|---|
| Women | Experimental | 18F-Flortaucipir and 11C-Pittsburgh compound-B radioligands will be used for experimental PET imaging of beta-amyloid and neurofibrillary tau pathology Receives: Drug: 18-F-Flortaucipir |
What is being measured
The primary outcome is the main question the study is designed to answer.
18F-Flortaucipir PET imaging
Cortical 18F-Flortaucipir PET imaging measured once in each participant
Measured: 1 day
Pittsburgh compound-B PET imaging
Global cortical SUVR measured once in each participant
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start27 Jun 2019
- Primary completionMay 2030 (estimated)
- Study completionMay 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 614 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Kejal Kantarci, Mayo Clinic
- Investigators
- Kejal Kantarci, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03821857
- Sponsor's protocol ID
- 18-008476
- Other IDs
- U54AG044170-09, R01AG093767
- Acronym
- SEED-AD
- Status last verified
- Nov 2025
- First submitted
- 25 Jan 2019
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 39711285
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex-Specific Effects of Endocrine Disruption on Aging and Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03821857
- Acronym / sponsor ID
- SEED-AD / 18-008476
- Conditions
- Alzheimer Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 614 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- May 2030 (estimated)
- Study completion
- May 2030 (estimated)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women | Experimental | Drug: 18-F-Flortaucipir18F-Flortaucipir and 11C-Pittsburgh compound-B radioligands will be used for experimental PET imaging of beta-amyloid and neurofibrillary tau pathology |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- African American Women
Key exclusion criteria (9 listed)
- Not able to read and speak English
- In hospice
- Claustrophobic
- If undergoing Tau imaging, cannot have QT Prolongation
- Mayo Clinic Jacksonville-
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18-F-FlortaucipirAlso: 11C-Pittsburgh Compound-BRadioligands for PET imaging of beta-amyloid and neurofibrillary tangle tau pathology | Drug | Women |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Derived from this study: PubMed 39711285Kantarci 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kejal Kantarci, MD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 18-F-Flortaucipir in people with Alzheimer Disease, run by Mayo Clinic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact June Kendall-Thomas, CRC (507-293-9397, kendallthomas.june15@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
18F-Flortaucipir PET imaging (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03821857, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.