Start: April 10, 2018
End: October 31, 2022
What Is This Study About?
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. This 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. 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.
Do I Qualify To Participate in This Study?
- 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
Must NOT have:
- 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 six months, congestive heart failure, evidence of atrial fibrillation, or other severe medical condition)
- Chronic kidney disease (glomerular filtration rate less than 40 ml 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 two 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 two 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)
Contact study personnel listed either under the general study contact or the location nearest you.
Wanpen Vongpatanasin, MD
Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.
Where Is This Study Located?
UT Southwestern Medical Center
Dallas, TX 75390
Lead: University of Texas Southwestern Medical Center
Texas Health Resources
Michigan State University
Source: ClinicalTrials.gov ID: NCT03354143