Brain Health in Midlife (ADORE BRAIN)

Brain Health in Midlife (ADORE BRAIN)

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

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Dementia; Alzheimer Disease; Pregnancy Related; Pre-Eclampsia; Gestational Hypertension; Brain Health
• Intervention / Treatment: Diagnostic test: A combination of various test and biomarkers will be completed to understand the effect of hypertensive disorders of pregnancy in brain health in midlife.

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • The University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Women who previously participated in the ADORE, received a hypertensive disorder diagnosis or had a healthy pregnancy during their participation.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hypertensive disorder of pregnancy; Women who were diagnosed with a hypertensive disorder of pregnancy during the ADORE study participation.	Diagnostic test: A combination of various test and biomarkers will be completed to understand the effect of hypertensive disorders of pregnancy in 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.
Healthy pregnancy; Women who participated in the ADORE study and had a healthy pregnancy during their participation.	Diagnostic test: A combination of various test and biomarkers will be completed to understand the effect of hypertensive disorders of pregnancy in 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiometabolic markers of middle age women	Assess cardiometabolic marker values differences between the women diagnosed with a hypertensive disorder of pregnancy to the values of the healthy control.	Baseline
Neurovascular hemodynamics of middle age women	Assess differences in heart rate via an ECG, and beat to beat blood pressure, cerebral blood flow, and pulse wave velocity) between the women diagnosed with hypertensive disorder of pregnancy to the values of the healthy control.	Baseline
Brain structure & function of middle age women	Assess differences in MRI MPRAGE, fMRI and DTI sequencing scan between the women diagnosed with hypertensive disorder of pregnancy to the values of the healthy control.	Baseline
Alzheimer's disease-related plasma biomarkers of middle age women	Assess value differences in a predetermined Alzheimer's disease-related plasma biomarkers between the women diagnosed with hypertensive disorder of pregnancy to the values of the healthy controls.	Baseline

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: National Institute on Aging (NIA); The University of Kansas Medical Center ADRC
• Investigators: Principal Investigator: Holly R Hull, PhD, The University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2024
• Primary Completion (Actual): June 13, 2025
• Study Completion (Actual): June 13, 2025

Study Registration Dates

• First Submitted: August 29, 2024
• First Submitted That Met QC Criteria: October 11, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): June 29, 2025
• Last Update Submitted That Met QC Criteria: June 26, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Hypertension; Eclampsia; Pre-Eclampsia; Hypertension, Pregnancy-Induced; Alzheimer Disease; Cardiovascular Diseases
• Other Study ID Numbers: STUDY00160885; P30AG072973 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No