Brain HealthADORE BRAINNCT06640842
Brain Health in Midlife
An observational study of Brain Health and Gestational Hypertension, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to learn if hypertensive disorders during pregnancy affects brain health in midlife. Read more about this study
- Who is it for?
- Ages 18 to 54 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Brain Health, Gestational Hypertension, Alzheimer Disease
- What is being tested?
- A combination of various tests and biomarkers will be completed to understand the effect of hypertensive disorders of pregnancy on brain health in midlife.
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2024to 13 Jun 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 54 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women who previously participated in the ADORE, received a hypertensive disorder diagnosis or had a healthy pregnancy during their participation.
Who may be able to join
- Participated in the ADORE trial ( R01 HD083292)
Who cannot join
- History of seizures or Epilepsy
- Pregnant at screening
- Ineligible to complete MRI due to metal in the body
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Brain Health in Midlife (ADORE BRAIN)
The purpose of this study is to learn if hypertensive disorders during pregnancy affects brain health in midlife.
- Conditions
- Brain Health, Gestational Hypertension, Alzheimer Disease, Dementia, Cardiovascular Diseases, Pregnancy Related
- Being tested
- A combination of various tests and biomarkers will be completed to understand the effect of hypertensive disorders of pregnancy on brain health in midlife.
- Medical subject headings
- Hypertension, Pregnancy-Induced, Alzheimer Disease, Dementia, Cardiovascular Diseases, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A combination of various tests and biomarkers will be completed to understand the effect of hypertensive disorders of pregnancy on brain health in midlife.Diagnostic test
Participants will be asked to complete a blood draw, 5-lead ECG, MRI, a series of cognitive assessments, dietary assessments, monitor sleep and physical activity and DXA scan.
| Study group | Role | What they receive |
|---|---|---|
| Hypertensive disorder of pregnancy | Women who were diagnosed with a hypertensive disorder of pregnancy during the ADORE study participation. Receives: Diagnostic Test: A combination of various tests and biomarkers will be completed to understand the effect of hypertensive disorders of pregnancy on brain health in midlife. | |
| Healthy pregnancy | Women who participated in the ADORE study and had a healthy pregnancy during their participation. Receives: Diagnostic Test: A combination of various tests and biomarkers will be completed to understand the effect of hypertensive disorders of pregnancy on brain health in midlife. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiometabolic Biomarkers - Glucose & Lipids
Assess differences in cardiometabolic biomarkers between the women diagnosed with a hypertensive disorder of pregnancy and healthy control.
Measured: Baseline
Cardiometabolic Biomarkers - Insulin
Assess cardiometabolic marker values differences between the women diagnosed with a hypertensive disorder of pregnancy to the values of the healthy control.
Measured: Baseline
Cardiometabolic Biomarkers - Hemoglobin A1C
Assess cardiometabolic marker values differences between the women diagnosed with a hypertensive disorder of pregnancy to the values of the healthy control.
Measured: Baseline
Neurovascular Hemodynamics - Heart Rate
Assess differences in heart rate, mean arterial pressure, cerebral blood flow, and pulse wave velocity between the women diagnosed with a hypertensive disorder of pregnancy and healthy control. Heart rate was measured using a 5-lead electrocardiogram.
Measured: Baseline
Neurovascular Hemodynamics - Mean Arterial Pressure
Assess differences in heart rate, mean arterial pressure, cerebral blood flow, and pulse wave velocity between the women diagnosed with a hypertensive disorder of pregnancy and healthy control. Mean arterial pressure was measured with each heart beat using a specialized cuff placed on the finger.
Measured: Baseline
Neurovascular Hemodynamics - Cerebral Blood Flow
Assess differences in heart rate, mean arterial pressure, cerebral blood flow, and pulse wave velocity between the women diagnosed with a hypertensive disorder of pregnancy and healthy control. Cerebral blood flow, the velocity at which blood travels through the middle cerebral artery, was measured using transcranial doppler ultrasound.
Measured: Baseline
Neurovascular Hemodynamics - Pulse Wave Velocity
Assess differences in heart rate, mean arterial pressure, cerebral blood flow, and pulse wave velocity between the women diagnosed with a hypertensive disorder of pregnancy and healthy control. Pulse wave velocity is an indicator of vessel stiffness and was measured using a specialized blood pressure cuff placed on the upper thigh.
Measured: Baseline
Brain Structure
Assess differences in brain structure between women diagnosed with a hypertensive disorder of pregnancy and healthy controls using fMRI. A T1-weighted structural scan was completed (3D MPRAGE sequence). Structural data was segmented using FreeSurfer to quantify brain volumes. Volumes are reported in cubic millimeters (mm^3).
Measured: Baseline
Brain Functional Connectivity
Assess differences in brain functional connectivity between women diagnosed with a hypertensive disorder of pregnancy and healthy controls using fMRI. A resting state scan run of gradient echo blood oxygen level dependent (BOLD) scans was completed. Resting state data was processed using analysis protocols that explored functional neural networks (i.e., default mode network (DMN), attention network, salience network). Functional connectivity is reported as Fisher z-transformed correlation coefficients derived from fMRI data.
Measured: Baseline
Alzheimer's Disease-related Biomarkers
Assess differences in Alzheimer's disease-related biomarkers between the women diagnosed with a hypertensive disorder of pregnancy and healthy control.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start23 Sep 2024
- Primary completion13 Jun 2025
- Study completion13 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Brain HealthStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Holly R Hull, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640842
- Sponsor's protocol ID
- STUDY00160885
- Other IDs
- P30AG072973
- Acronym
- ADORE BRAIN
- Status last verified
- Jun 2026
- First submitted
- 29 Aug 2024
- Last updated
- 14 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Health in Midlife (ADORE BRAIN)
- ClinicalTrials.gov ID
- NCT06640842
- Acronym / sponsor ID
- ADORE BRAIN / STUDY00160885
- Conditions
- Brain Health, Gestational Hypertension, Alzheimer Disease, Dementia, Cardiovascular Diseases, Pregnancy Related
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 13 Jun 2025 (actual)
- Study completion
- 13 Jun 2025 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Posted 14 Jul 2026
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 learn if hypertensive disorders during pregnancy affects brain health in midlife.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypertensive disorder of pregnancy | – | Diagnostic Test: A combination of various tests and biomarkers will be completed to understand the effect of hypertensive disorders of pregnancy on brain health in midlife.Women who were diagnosed with a hypertensive disorder of pregnancy during the ADORE study participation. |
| Healthy pregnancy | – | Diagnostic Test: A combination of various tests and biomarkers will be completed to understand the effect of hypertensive disorders of pregnancy on brain health in midlife.Women who participated in the ADORE study and had a healthy pregnancy during their participation. |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women who previously participated in the ADORE, received a hypertensive disorder diagnosis or had a healthy pregnancy during their participation.
Key inclusion criteria (1 listed)
- Participated in the ADORE trial ( R01 HD083292)
Key exclusion criteria (3 listed)
- History of seizures or Epilepsy
- Pregnant at screening
- Ineligible to complete MRI due to metal in the body
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 |
|---|---|---|
| A combination of various tests and biomarkers will be completed to understand the effect of hypertensive disorders of pregnancy on brain health in midlife.Participants will be asked to complete a blood draw, 5-lead ECG, MRI, a series of cognitive assessments, dietary assessments, monitor sleep and physical activity and DXA scan. | Diagnostic test | Healthy pregnancy, Hypertensive disorder of pregnancy |
Primary outcome
Cardiometabolic Biomarkers - Glucose & Lipids
Time frame: Baseline
Assess differences in cardiometabolic biomarkers between the women diagnosed with a hypertensive disorder of pregnancy and healthy control.
Cardiometabolic Biomarkers - Insulin
Time frame: Baseline
Assess cardiometabolic marker values differences between the women diagnosed with a hypertensive disorder of pregnancy to the values of the healthy control.
Cardiometabolic Biomarkers - Hemoglobin A1C
Time frame: Baseline
Assess cardiometabolic marker values differences between the women diagnosed with a hypertensive disorder of pregnancy to the values of the healthy control.
Neurovascular Hemodynamics - Heart Rate
Time frame: Baseline
Assess differences in heart rate, mean arterial pressure, cerebral blood flow, and pulse wave velocity between the women diagnosed with a hypertensive disorder of pregnancy and healthy control. Heart rate was measured using a 5-lead electrocardiogram.
Neurovascular Hemodynamics - Mean Arterial Pressure
Time frame: Baseline
Assess differences in heart rate, mean arterial pressure, cerebral blood flow, and pulse wave velocity between the women diagnosed with a hypertensive disorder of pregnancy and healthy control. Mean arterial pressure was measured with each heart beat using a specialized cuff placed on the finger.
Neurovascular Hemodynamics - Cerebral Blood Flow
Time frame: Baseline
Assess differences in heart rate, mean arterial pressure, cerebral blood flow, and pulse wave velocity between the women diagnosed with a hypertensive disorder of pregnancy and healthy control. Cerebral blood flow, the velocity at which blood travels through the middle cerebral artery, was measured using transcranial doppler ultrasound.
Neurovascular Hemodynamics - Pulse Wave Velocity
Time frame: Baseline
Assess differences in heart rate, mean arterial pressure, cerebral blood flow, and pulse wave velocity between the women diagnosed with a hypertensive disorder of pregnancy and healthy control. Pulse wave velocity is an indicator of vessel stiffness and was measured using a specialized blood pressure cuff placed on the upper thigh.
Brain Structure
Time frame: Baseline
Assess differences in brain structure between women diagnosed with a hypertensive disorder of pregnancy and healthy controls using fMRI. A T1-weighted structural scan was completed (3D MPRAGE sequence). Structural data was segmented using FreeSurfer to quantify brain volumes. Volumes are reported in cubic millimeters (mm^3).
Brain Functional Connectivity
Time frame: Baseline
Assess differences in brain functional connectivity between women diagnosed with a hypertensive disorder of pregnancy and healthy controls using fMRI. A resting state scan run of gradient echo blood oxygen level dependent (BOLD) scans was completed. Resting state data was processed using analysis protocols that explored functional neural networks (i.e., default mode network (DMN), attention network, salience network). Functional connectivity is reported as Fisher z-transformed correlation coefficients derived from fMRI data.
Alzheimer's Disease-related Biomarkers
Time frame: Baseline
Assess differences in Alzheimer's disease-related biomarkers between the women diagnosed with a hypertensive disorder of pregnancy and healthy control.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Holly R Hull, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Health and Gestational Hypertension, run by University of Kansas Medical Center at 1 site 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 1 inclusion and 3 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 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 14 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cardiometabolic Biomarkers - Glucose & Lipids (time frame: Baseline). The study lists 10 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 14 Jul 2026.