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

  • STATUS
    Recruiting
  • End date
    Oct 31, 2022
  • participants needed
    120
  • sponsor
    University of Texas Southwestern Medical Center
Updated on 16 June 2021
electrocardiogram
hypertension
calcium
cognitive impairment
dementia
mini-mental state examination
amyloid
mental state examination
beta amyloid protein
antihypertensive drugs
angiotensin ii

Summary

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.

Description


Details
Condition Vascular Diseases, Alzheimer's Disease, Diabetes and Hypertension, High Blood Pressure (Hypertension), High Blood Pressure (Hypertension - Pediatric)
Treatment Standard Care, Intensive Treatment
Clinical Study IdentifierNCT03354143
SponsorUniversity of Texas Southwestern Medical Center
Last Modified on16 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 55-79, all races/ethnicities, and both women and men are eligible
Mini-mental state exam (MMSE) > 26 to exclude cognitive impairment or dementia
Healthy normotensive subjects (24-hour ambulatory BP<125/75 mmHg without use of antihypertensive medication)
Patients with hypertension defined as 24-hour SBP 130 mmHg , patients on BP medications are eligible
Patients with hypertension are willing to be randomized into either treatment group and ability to return to clinic or laboratory for follow-up visits over 12 months
Fluency in English, adequate visual and auditory acuity to allow neuropsychological testing
Screening laboratory tests and ECG without significant abnormalities that might interfere with the study

Exclusion Criteria

History of stroke, transient ischemic attack, traumatic brain injury or severe cerebrovascular disease by clinical diagnosis or past MRI/CT
Diagnosis of AD or other type of dementia and neurodegenerative diseases
Evidence of severe depression or other DSM-V Axis I psychopathology
Unstable heart disease based on clinical judgment (heart attack/cardiac arrest, cardiac bypass procedures within previous 6 months and congestive heart failure), evidence of atrial fibrillation on ECG, or other severe medical conditions
Chronic kidney diseases with GFR < 40 ml/min
Orthostatic hypotension, defined as standing SBP<100 mmHg
History of significant autoimmune disorders such as systemic lupus erythematosus, rheumatoid arthritis and polymyalgia rheumatica
History of drug or alcohol abuse within the last 2 years
Diagnosis of uncontrolled diabetes mellitus (fasting blood sugar 126 mg/dL or A1C >7.5%)
Obstructive sleep apnea
Regularly smoking cigarette within the past year
Severe obesity with BMI 45
Participants enrolled in another investigational drug or device study within the past 2 months
Carotid stent or sever stenosis (> 50%)
Pacemaker or other medical device of metal that precludes performing MRI
History of B12 deficiency or hypothyroidism (stable treatment for at least 3 months is allowable)
Any conditions judged by the study investigators to be either medically inappropriate, or risky for participant or likely to have poor study adherence
Claustrophobia
Pregnancy
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