Alzheimer DementiaKEEPSNCT03718494
Continuation of The Kronos Early Estrogen Prevention Study (KEEPS)
An observational study of Alzheimer Dementia, run by Mayo Clinic at 6 sites in United States.
Trial summary
The purpose of this study is to investigate how blood flow to the brain affects cognition in women who are postmenopausal, and how the use of hormone therapy early in menopause might change brain function. The testing in this study will add to the knowledge about brain aging in women. Read more about this study
- Who is it for?
- Ages 49 to 72 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Dementia
- What is being tested?
- Brain Magnetic Resonance Imaging (MRI), F-18 Florbetapir Positron Emission Tomography (PET) Imaging and F-18 AV-1451 Positron Emission Tomography (PET) Imaging
- Type of treatment
- Injection or infusion
- How many people
- 299 participants
- Where
- 6 sitesUnited States
- Study dates
- 22 May 2019to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 49 to 72 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women that participated in the Kronos Early Estrogen Prevention Study (KEEP; NCT00154180) and completed brain imaging or cognitive testing and indicated that it would be acceptable to contact them for future research opportunities.
Who may be able to join
- Participated in the original KEEPS trial.
- Able to understand study procedures.
- Willing to sign an authorization of consent in order to participate in this study.
Who cannot join
- Women who have contraindications to MRI or PET for safety reasons, such as an MRI-incompatible implant or claustrophobia.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Yale University
New Haven, Connecticut, 06520
Columbia University
New York, New York, 10027
Banner Health
Phoenix, Arizona, 85032
University of Utah
Salt Lake City, Utah, 84112
University of California San Francisco
San Francisco, California, 94158
About this study
Official title: Prevention of Alzheimer's Disease in Women: Risks and Benefits of Hormone Therapy -Continuation of: "The Kronos Early Estrogen Prevention Study (KEEPS)"
The purpose of this study is to investigate how blood flow to the brain affects cognition in women who are postmenopausal, and how the use of hormone therapy early in menopause might change brain function. The testing in this study will add to the knowledge about brain aging in women. Researchers will determine if blood flow to the brain, brain structure, and cognition differences among women who took hormones in the past as part of Kronos Early Estrogen Prevention Study (KEEPS; NCT00154180), are currently taking hormones, or never took menopausal hormones.
Read the detailed description
This is a continuation of the Kronos Early Estrogen Prevention Study (KEEPS) (KEEPS; NCT00154180), a multicenter double blinded, placebo-controlled, randomized trial funded by the Kronos Longevity Research Institute, Phoenix, AZ to test the hypothesis that hormone therapy started early in menopause (within the "window of opportunity") would slow progression of atherosclerosis as measured by changes in carotid artery intima-medial thickening and coronary arterial calcification.
This study will involve a single follow-up evaluation of brain imaging and cognitive function of women who were randomized to menopausal hormone therapy (mHT) or placebo, approximately 13 years post-randomization and nine years after the end of mHT administration phase in KEEPS (NCT00154180). No interventions are given as part of this study; any current hormonal treatments are by choice and prescribed by the participant's personal physician.
- Conditions
- Alzheimer Dementia
- Being tested
- Brain Magnetic Resonance Imaging (MRI), F-18 Florbetapir Positron Emission Tomography (PET) Imaging, F-18 AV-1451 Positron Emission Tomography (PET) Imaging, Neuropsychological Testing
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Magnetic Resonance Imaging (MRI)Diagnostic test
Performed on a single 3T system and sequences will be acquired in a single sitting with an exam time under 45 minutes.
F-18 Florbetapir Positron Emission Tomography (PET) ImagingDiagnostic test
After a 50-minute uptake period, the patient will be positioned on the scanner bed with instructions to remain motionless. Injection of 10 mCi of 18F-Florbetapir (target dose 370 MBq, range 296 - 444 MBq) given. A helical CT image will be obtained at 50 minutes after injection of 18F-Florbetapir, followed by a 20-minute PET acquisition consisting of four 5-minute dynamic frames.
F-18 AV-1451 Positron Emission Tomography (PET) ImagingDiagnostic test
Intravenous bolus injection of approximately 370 MBq (10 mCi) of 18F- AV-1451 (approved under IND 124449). PET/CT image acquisition will include a low dose CT and then a 20-minute PET acquisition starting at 50-60 minutes after injection of 18F-T807 and will be performed as 4, 5-minute frames that will then be summed into one static frame. Serial frames will allow for adjustment in the case of patient motion.
Neuropsychological TestingOther
A comprehensive battery of standardized neuropsychological tests administered by trained personnel.
| Study group | Role | What they receive |
|---|---|---|
| Menopausal Hormone Therapy (mHT) Group | Women that participated in and completed the KEEPS study (NCT00154180) that were randomized to receive menopausal hormone therapy (mHT) will have a follow up brain Positron Emission Tomography (PET) imaging (F-18 Florbetapir PET or F-18 AV-1451 PET) and cognitive function testing. Receives: Diagnostic Test: Brain Magnetic Resonance Imaging (MRI); Diagnostic Test: F-18 Florbetapir Positron Emission Tomography (PET) Imaging; Diagnostic Test: F-18 AV-1451 Positron Emission Tomography (PET) Imaging; Other: Neuropsychological Testing | |
| Placebo Group | Women that participated in and completed the KEEPS study (NCT00154180) that were randomized to receive placebo treatment will have a follow up brain Positron Emission Tomography (PET) imaging (F-18 Florbetapir PET or F-18 AV-1451 PET) and cognitive function testing. Receives: Diagnostic Test: Brain Magnetic Resonance Imaging (MRI); Diagnostic Test: F-18 Florbetapir Positron Emission Tomography (PET) Imaging; Diagnostic Test: F-18 AV-1451 Positron Emission Tomography (PET) Imaging; Other: Neuropsychological Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aβ PET SUVR
This measure is derived from a PET imaging study that images the deposition of the amyloid plaques of Alzheimer's disease in the brain
Measured: 4 years
WMH volume
This measure is derived from an MRI study that images the brain structure. WMH is measured from specific regions of the brain that are vulnerable to cerebrovascular disease related injury.
Measured: 4 years
Regional cortical thickness
This measure is derived from an MRI study that images the brain structure. The cortical thickness is measured from specific regions of the brain that are vulnerable to Alzheimer's disease related neurodegeneration.
Measured: 4 years
AV-1451
This measure is derived from a PET imaging study that images the deposition of the tau protein of Alzheimer's disease in the brain
Measured: 4 years
Global cognitive function
This measurement is derived from multiple neuropsychometric tests that measure various cognitive abilities.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start22 May 2019
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DementiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University, Yale University, Utah State University, Brigham and Women's Hospital, Banner Alzheimer's Institute, University of California, San Francisco, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Kejal Kantarci, Mayo Clinic
- Investigators
- Kejal Kantarci, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718494
- Sponsor's protocol ID
- 12-008697
- Other IDs
- 1RF1AG057547-01
- Acronym
- KEEPS
- Status last verified
- Jul 2023
- First submitted
- 23 Oct 2018
- Last updated
- 17 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study data will be de-identified and transferred to the Mayo Clinic and UW through secure file transfer protocols. Data will be stored at each institution's data center.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Alzheimer's Disease in Women: Risks and Benefits of Hormone Therapy -Continuation of: "The Kronos Early Estrogen Prevention Study (KEEPS)"
- ClinicalTrials.gov ID
- NCT03718494
- Acronym / sponsor ID
- KEEPS / 12-008697
- Conditions
- Alzheimer Dementia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Columbia University, Yale University, Utah State University, Brigham and Women's Hospital, Banner Alzheimer's Institute, University of California, San Francisco, National Institute on Aging (NIA)
- Study start
- 22 May 2019 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 24 Oct 2018 (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 purpose of this study is to investigate how blood flow to the brain affects cognition in women who are postmenopausal, and how the use of hormone therapy early in menopause might change brain function. The testing in this study will add to the knowledge about brain aging in women. Researchers will determine if blood flow to the brain, brain structure, and cognition differences among women who took hormones in the past as part of Kronos Early Estrogen Prevention Study (KEEPS; NCT00154180), are currently taking hormones, or never took menopausal hormones.
Detailed description
This is a continuation of the Kronos Early Estrogen Prevention Study (KEEPS) (KEEPS; NCT00154180), a multicenter double blinded, placebo-controlled, randomized trial funded by the Kronos Longevity Research Institute, Phoenix, AZ to test the hypothesis that hormone therapy started early in menopause (within the "window of opportunity") would slow progression of atherosclerosis as measured by changes in carotid artery intima-medial thickening and coronary arterial calcification.
This study will involve a single follow-up evaluation of brain imaging and cognitive function of women who were randomized to menopausal hormone therapy (mHT) or placebo, approximately 13 years post-randomization and nine years after the end of mHT administration phase in KEEPS (NCT00154180). No interventions are given as part of this study; any current hormonal treatments are by choice and prescribed by the participant's personal physician.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Menopausal Hormone Therapy (mHT) Group | – | Diagnostic Test: Brain Magnetic Resonance Imaging (MRI), Diagnostic Test: F-18 Florbetapir Positron Emission Tomography (PET) Imaging, Diagnostic Test: F-18 AV-1451 Positron Emission Tomography (PET) Imaging, Other: Neuropsychological TestingWomen that participated in and completed the KEEPS study (NCT00154180) that were randomized to receive menopausal hormone therapy (mHT) will have a follow up brain Positron Emission Tomography (PET) imaging (F-18 Florbetapir PET or F-18 AV-1451 PET) and cognitive function testing. |
| Placebo Group | – | Diagnostic Test: Brain Magnetic Resonance Imaging (MRI), Diagnostic Test: F-18 Florbetapir Positron Emission Tomography (PET) Imaging, Diagnostic Test: F-18 AV-1451 Positron Emission Tomography (PET) Imaging, Other: Neuropsychological TestingWomen that participated in and completed the KEEPS study (NCT00154180) that were randomized to receive placebo treatment will have a follow up brain Positron Emission Tomography (PET) imaging (F-18 Florbetapir PET or F-18 AV-1451 PET) and cognitive function testing. |
Who may qualify
- Ages
- 49 to 72 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women that participated in the Kronos Early Estrogen Prevention Study (KEEP; NCT00154180) and completed brain imaging or cognitive testing and indicated that it would be acceptable to contact them for future research opportunities.
Key inclusion criteria (3 listed)
- Participated in the original KEEPS trial.
- Able to understand study procedures.
- Willing to sign an authorization of consent in order to participate in this study.
Key exclusion criteria (1 listed)
- Women who have contraindications to MRI or PET for safety reasons, such as an MRI-incompatible implant or claustrophobia.
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 |
|---|---|---|
| Brain Magnetic Resonance Imaging (MRI)Performed on a single 3T system and sequences will be acquired in a single sitting with an exam time under 45 minutes. | Diagnostic test | Menopausal Hormone Therapy (mHT) Group, Placebo Group |
| F-18 Florbetapir Positron Emission Tomography (PET) ImagingAfter a 50-minute uptake period, the patient will be positioned on the scanner bed with instructions to remain motionless. Injection of 10 mCi of 18F-Florbetapir (target dose 370 MBq, range 296 - 444 MBq) given. A helical CT image will be obtained at 50 minutes after injection of 18F-Florbetapir, followed by a 20-minute PET acquisition consisting of four 5-minute dynamic frames. | Diagnostic test | Menopausal Hormone Therapy (mHT) Group, Placebo Group |
| F-18 AV-1451 Positron Emission Tomography (PET) ImagingIntravenous bolus injection of approximately 370 MBq (10 mCi) of 18F- AV-1451 (approved under IND 124449). PET/CT image acquisition will include a low dose CT and then a 20-minute PET acquisition starting at 50-60 minutes after injection of 18F-T807 and will be performed as 4, 5-minute frames that will then be summed into one static frame. Serial frames will allow for adjustment in the case of patient motion. | Diagnostic test | Menopausal Hormone Therapy (mHT) Group, Placebo Group |
| Neuropsychological TestingA comprehensive battery of standardized neuropsychological tests administered by trained personnel. | Other | Menopausal Hormone Therapy (mHT) Group, Placebo Group |
Primary outcome
Aβ PET SUVR
Time frame: 4 years
This measure is derived from a PET imaging study that images the deposition of the amyloid plaques of Alzheimer's disease in the brain
WMH volume
Time frame: 4 years
This measure is derived from an MRI study that images the brain structure. WMH is measured from specific regions of the brain that are vulnerable to cerebrovascular disease related injury.
Regional cortical thickness
Time frame: 4 years
This measure is derived from an MRI study that images the brain structure. The cortical thickness is measured from specific regions of the brain that are vulnerable to Alzheimer's disease related neurodegeneration.
AV-1451
Time frame: 4 years
This measure is derived from a PET imaging study that images the deposition of the tau protein of Alzheimer's disease in the brain
Global cognitive function
Time frame: 4 years
This measurement is derived from multiple neuropsychometric tests that measure various cognitive abilities.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No. Study data will be de-identified and transferred to the Mayo Clinic and UW through secure file transfer protocols. Data will be stored at each institution's data center.
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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. This study is not recruiting at the moment.
Kejal Kantarci, M.D. principal investigator
Mayo Clinic
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Dementia, run by Mayo Clinic at 6 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aβ PET SUVR (time frame: 4 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2023.