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Blood Pressure Control to Reduce Amyloid-Beta Accumulation (HIPAC)

Recruiting

This Phase II study will test whether lowering blood pressure using antihypertensive drugs alters brain pulsatility, a measure of blood flow, and reduces amyloid-beta accumulation in the brains of older adults.

Minimum Age Maximum Age Gender Healthy Volunteers
55 Years 79 Years All Yes
April 10, 2018
October 31, 2022
120

  • Mini-Mental State Examination score greater than 26 to exclude cognitive impairment or dementia
  • With or without high blood pressure, defined as either 24-hour blood pressure less than 125/75 without use of antihypertensive medication or systolic blood pressure of 130 or higher (with or without blood pressure medications)
  • Adequate visual and auditory ability to complete neuropsychological testing
  • Screening laboratory tests and electrocardiography without significant abnormalities that might interfere with the study
  • Fluent in English

  • History of stroke, transient ischemic attack, traumatic brain injury, or severe cerebrovascular disease
  • Diagnosis of Alzheimer's disease or other type of dementia and neurodegenerative disease
  • Severe depression or other psychological disorder
  • Unstable heart disease (heart attack/cardiac arrest, cardiac bypass procedures within past 6 months, congestive heart failure, evidence of atrial fibrillation, or other severe medical condition)
  • Chronic kidney disease (glomerular filtration rate less than 40 milliliters per minute)
  • Orthostatic hypotension (standing systolic blood pressure less than 100)
  • History of significant autoimmune disorders, such as systemic lupus erythematosus, rheumatoid arthritis, and polymyalgia rheumatica
  • Drug or alcohol abuse within the past 2 years
  • Uncontrolled diabetes
  • Obstructive sleep apnea
  • Use of cigarettes regularly in past year
  • Body mass index of 45 or higher
  • Participation in another investigational drug or device study in past 2 months
  • Carotid stent or severe stenosis (greater than 50%)
  • Pacemaker or other metal medical device that prevents magnetic resonance imaging
  • History of B12 deficiency or hypothyroidism (stable treatment for at least 3 months is allowed)
  • Claustrophobia
  • Pregnant

Amyloid-beta is a protein found in the brains of people with Alzheimer's disease. Hypertension may increase amyloid-beta accumulation and affect memory and thinking ability in older adults. In this study researchers are testing whether treating high blood pressure alters brain pulsatility, which in turn reduces amyloid-beta accumulation and improves brain structure and function.

Participants will take a calcium channel blocker (amlodipine, Amvaz or Norvasc), angiotensin II receptor blocker (losartan, Cozaar), and other antihypertensive drugs approved by the U.S. Food and Drug Administration to reduce blood pressure. Doses will be based on the amount needed to reach a 24-hour systolic blood pressure target of either 120 or less, or 130 or less.

Name City State Zip Status Primary Contact
UT Southwestern Medical Center
Dallas Texas 75390 Recruiting

University of Texas Southwestern Medical Center

  • Texas Health Resources
  • Michigan State University

Name Role Affiliation
Rong Zhang, PhD Principal Investigator University of Texas Southwestern Medical Center and Texas Health Resources
Wanpen Vongpatanasin, MD Principal Investigator University of Texas Southwestern Medical Center
David Zhu, PhD Principal Investigator Michigan State University

Name Phone Email
Wanpen Vongpatanasin, MD 214-648-3180 Wanpen.Vongpatanasin@UTSouthwestern.edu

NCT03354143

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