UT Southwestern Medical Center
Dallas, Texas, 75390, United States
NCT Number: NCT03354143
The aim of this study is to determine if lowering blood pressure using FDA approved medication (antihypertensive drugs) alters brain pulsatility and reduces brain amyloid beta protein accumulation in older adults. Amyloid beta protein is high in the brain of older adults with Alzheimer's disease. Hypertension may increase brain amyloid beta protein accumulation and affect memory and thinking ability in older adults. However, whether lowering blood pressure reduces brain amyloid beta protein and improves brain function is inconclusive.
The investigators hypothesize that treating high blood pressure alters brain pulsatility, which in turn reduces brain amyloid beta protein accumulation and improves brain structure and function.
Looking for future studies?
Notify Me55 year–79 year
All sexes
Interventional
Phase 2
Dallas, Texas, 75390, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Calcium channel blocker (CCB, amlodipine), angiotensin II receptor blocker (ARB, losartan), and other antihypertensive drugs will be used to reduce 24-hour SBP ≤ 130 mmHg.
Calcium channel blocker (CCB, amlodipine), angiotensin II receptor blocker (ARB, losartan), and other antihypertensive drugs will be used to reduce 24-hour SBP ≤ 120 mmHg.
Time frame: Baseline and 12-months
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
Time frame: Baseline and 12-months
changes in overall average 24 hr ambulatory systolic blood pressure will be assessed SpaceLabs monitor
Time frame: Baseline and 12-months
changes in overall average 24 hr ambulatory diastolic blood pressure will be assessed SpaceLabs monitor
Time frame: Baseline and 12-months
Time frame: Baseline and 12-months
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.
Time frame: Baseline and 12-months
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.
Time frame: Baseline and 12-months
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.
Time frame: Baseline and 12-months
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
Time frame: Baseline and 12-months
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
University of Texas Southwestern Medical Center
Other
Acronym: HIPAC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02742597
Alzheimer Disease, Alzheimer's Disease
London, Ontario, Canada
View Trial DetailsNCT02789800
Alzheimer Disease, Alzheimer's Disease
Chicoutimi, Quebec, Canada
View Trial DetailsNCT02913664
Alzheimer Disease, Behavior
Kansas City, Kansas, United States
View Trial DetailsNCT05331144
Alzheimer Disease, Brain Diseases
Dallas, Texas, United States
View Trial Details