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Brain Health in Midlife

Brain Health in Midlife (ADORE BRAIN)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06640842
Acronym
ADORE BRAIN
Enrollment
24
Registered
2024-10-15
Start date
2024-09-23
Completion date
2025-06-13
Last updated
2026-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Brain Health, Cardiovascular Diseases, Dementia, Gestational Hypertension, Pre-Eclampsia, Pregnancy Related

Brief summary

The purpose of this study is to learn if hypertensive disorders during pregnancy affects brain health in midlife.

Interventions

DIAGNOSTIC_TESTA 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.

Sponsors

University of Kansas Medical Center
Lead SponsorOTHER
National Institute on Aging (NIA)
CollaboratorNIH

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 54 Years
Healthy volunteers
Yes

Inclusion criteria

* Participated in the ADORE trial ( R01 HD083292)

Exclusion criteria

* History of seizures or Epilepsy * Pregnant at screening * Ineligible to complete MRI due to metal in the body

Design outcomes

Primary

MeasureTime frameDescription
Cardiometabolic Biomarkers - Glucose & LipidsBaselineAssess differences in cardiometabolic biomarkers between the women diagnosed with a hypertensive disorder of pregnancy and healthy control.
Cardiometabolic Biomarkers - InsulinBaselineAssess cardiometabolic marker values differences between the women diagnosed with a hypertensive disorder of pregnancy to the values of the healthy control.
Cardiometabolic Biomarkers - Hemoglobin A1CBaselineAssess cardiometabolic marker values differences between the women diagnosed with a hypertensive disorder of pregnancy to the values of the healthy control.
Neurovascular Hemodynamics - Heart RateBaselineAssess 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 PressureBaselineAssess 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 FlowBaselineAssess 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 VelocityBaselineAssess 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 StructureBaselineAssess 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 ConnectivityBaselineAssess 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 BiomarkersBaselineAssess differences in Alzheimer's disease-related biomarkers between the women diagnosed with a hypertensive disorder of pregnancy and healthy control.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORHolly R Hull, PhD

University of Kansas Medical Center

Baseline characteristics

Characteristic
Age, Continuous41.8 years
STANDARD_DEVIATION 3.46
BMI29.550 kg/m^2
STANDARD_DEVIATION 6.7084
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
8 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
1 Participants
Race (NIH/OMB)
Black or African American
1 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
Race (NIH/OMB)
White
20 Participants
Sex: Female, Male
Female
12 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 120 / 12
other
Total, other adverse events
0 / 120 / 12
serious
Total, serious adverse events
0 / 120 / 12

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 15, 2026