Actively Recruiting
Impact of Intensive Treatment of SBP on Brain Perfusion, Amyloid, and Tau (IPAT Study)
Led by Rong Zhang · Updated on 2025-08-05
180
Participants Needed
1
Research Sites
270 weeks
Total Duration
On this page
Sponsors
R
Rong Zhang
Lead Sponsor
N
National Institute on Aging (NIA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to determine if intensive lowering of systolic blood pressure (SBP), using FDA approved medications (antihypertensive), reduces Alzheimer's Disease pathology (i.e., excessive brain amyloid and tau protein deposition) in older adults at high risk for memory decline or dementia.
CONDITIONS
Official Title
Impact of Intensive Treatment of SBP on Brain Perfusion, Amyloid, and Tau (IPAT Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 60 to 85 years, all races and both sexes are eligible
- Mini-Mental State Exam score of 26 or higher to exclude dementia; may be rescreened after 7 days based on judgment
- Systolic blood pressure (SBP) between 130 and 180 mmHg if on 0 or 1 antihypertensive medication; adjusted SBP ranges allowed for up to 4 medications
- Willingness to be randomized and able to attend follow-up visits over 24 months
- Fluent in English or Spanish with adequate vision and hearing for cognitive testing
- Must have a regular healthcare provider
You will not qualify if you...
- History of stroke, major cerebrovascular disease, or brain lesions based on clinical judgment or imaging
- Diagnosis of Alzheimer's, other dementias, Parkinson's, seizure disorder, multiple sclerosis, severe head trauma, or normal pressure hydrocephalus
- Severe major depression or significant psychiatric disorders interfering with study adherence
- Unstable heart disease or severe medical conditions
- History of atrial fibrillation with symptoms or certain heart rate abnormalities
- Systolic BP ≥180 mmHg or diastolic BP ≥110 mmHg; orthostatic hypotension
- Significant autoimmune disorders such as lupus or rheumatoid arthritis
- History of alcoholism or drug abuse in past five years
- Uncontrolled diabetes (A1C >7.5%) or insulin treatment
- Regular smoking within past year
- Pacemaker or metal device incompatible with MRI
- Women who can become pregnant or are breastfeeding unless postmenopausal for 2 years or surgically sterile
- Participation in another drug/device study currently or within past 2 months
- Severe obesity with BMI over 40
- Allergy to angiotensin receptor blockers or amlodipine
- Abnormal lab tests (e.g., liver enzymes, kidney function)
- Medical conditions limiting survival to less than 3 years
- Conditions or circumstances judged by investigator to interfere with participation or compliance, such as plans to move, lack of support, distance or transportation issues, nursing home residence, or living with a partner also in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
T
Tristyn Hall-Curtis, MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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