Trial Outcomes & Findings for Hypertension, Intracranial Pulsatility and Brain Amyloid-beta Accumulation in Older Adults (HIPAC Trial) (NCT NCT03354143)

85 participants enrolled include 40 (Control group subjects-no intervention) and 45 participants (undergo intervention). These 45 subjects are randomized to either Standard care or Intensive care interventions that is summarized in the table below. Control group was not randomized and they did not receive an experimental intervention but received SOC.

Hypertension, Intracranial Pulsatility and Brain Amyloid-beta Accumulation in Older Adults (HIPAC Trial)

Changes (12 month timepoint minus baseline) in intracranial pulsatility will be measured with CINE phase-contrast MRI. We will use the velocity-encoded CINE PC MRI to measure intracranial pulsatility. Pulsatility measured in mm per cardiac cycle

changes in overall average 24 hr ambulatory systolic blood pressure will be assessed SpaceLabs monitor

changes in overall average 24 hr ambulatory diastolic blood pressure will be assessed SpaceLabs monitor

White matter hyperintensities (WMH) on brain T2 fluid-attenuated inversion recovery (FLAIR) magnetic resonance images (MRI) are commonly observed in older adults over 65 years old, and more extensive in those with vascular or Alzheimer's disease type of dementia. Qualitative and quantitative WMH characterization has been used as a biomarker to assist cerebral small vessel disease diagnosis and to assess treatment effects. In this report, the size of the WMH has been assessed with the PGS software, the top performer of the deep-learning algorithms from the 2017 MICCAI WMH segmentation challenge. The unit of the WMH total size presented in this report is in mL.

Fractional Anisotropy (FA) values are a measure of how directed diffusion is in a tissue, typically ranging from 0 to 1. A value of 0 indicates isotropic diffusion (diffusion is the same in all directions), while a value of 1 indicates highly anisotropic diffusion (diffusion is restricted to a single direction). FA is often used in diffusion tensor imaging (DTI) and is thought to reflect fiber density, axonal diameter, and myelination in white matter.

The brain's functional connectivity, particularly within the Default Mode Network (DMN), can be assessed using functional magnetic resonance imaging (fMRI) through the correlations between the activity of the brain regions within a network. In this report, the DMN regions were identified with a seed-based approach from another clinical trial with 420 subjects of a similar population. By identifying regions of interest (ROIs) within the DMN, researchers can analyze how these regions connect and interact with each other, revealing information about brain activity and potentially aiding in the diagnosis and understanding of various neurological and psychiatric conditions. Here, the functional connectivity of the DMN brain regions is reported in the unit of Pearson correlation R, with a range of 0 to 1 in this application. A high R value indicates a high level of connectivity.

PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Four items are used to assess global physical health. Three of these are administered using five-category response scales, and one item (rating of pain on average) uses a response scale of 0-10 that is recoded to five categories (0 = 1; 1-3 = 2; 4-6 = 3; 7-9 = 4; 10 = 5). T-score Metric: PROMIS measures use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric: A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function).A score of 60 is one standard deviation above the average population

PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. Four items are used to assess global physical health. Three of these are administered using five-category response scales, and one item (rating of pain on average) uses a response scale of 0-10 that is recoded to five categories (0 = 1; 1-3 = 2; 4-6 = 3; 7-9 = 4; 10 = 5). T-score Metric: PROMIS measures use a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. On the T-score metric: A score of 40 is one SD lower than the mean of the reference population. A score of 60 is one SD higher than the mean of the reference population. For PROMIS measures, higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function). A score of 60 is one standard deviation above the average population