Actively Recruiting
Impact of Intensive Treatment of Systolic Blood Pressure on Brain Perfusion, Amyloid, and Tau in Older Adults (IPAT Study)
Led by Rong Zhang · Updated on 2025-08-05
180
Participants Needed
1
Research Sites
30 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
Researchers are evaluating whether intensive lowering of systolic blood pressure (SBP) with FDA-approved medications can reduce Alzheimer's disease-related brain changes in older adults at high risk for memory decline or dementia. This Phase 2 trial focuses on adults aged 60 to 85 who have high blood pressure, a family history of dementia, or subjective memory complaints. The study also investigates how lowering blood pressure affects brain volume, blood flow, neural connectivity, and cognitive performance. Participants are randomly assigned to one of two groups: an intensive treatment group aiming to lower SBP below 120 mmHg using angiotensin II receptor blockers (losartan), calcium channel blockers (amlodipine), and other antihypertensive drugs as needed; or a usual care group following their primary care provider's blood pressure recommendations. This open-label trial spans 24 months with ongoing monitoring and treatment adjustments based on group assignment. Throughout the 24-month study, participants undergo brain imaging including MRI scans to measure amyloid and tau protein levels, cerebral blood flow, brain network connectivity, and white matter changes. Cognitive tests and assessments of arterial stiffness are conducted at baseline, 12 months, and 24 months. The primary outcome is the change in brain fibrillar beta-amyloid protein over 24 months, with various secondary measures tracking brain tau deposition, blood flow, and neurocognitive function. Safety and adherence are monitored regularly, requiring participants to have a regular healthcare provider and ability to attend follow-up visits.
CONDITIONS
Brief 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, any race or ethnicity, all sexes
- Mini-Mental State Exam score of 26 or higher
- Systolic blood pressure between 130 and 180 mmHg depending on number of antihypertensive medications
- Willingness to be randomized and ability to attend follow-up visits for 24 months
- Fluency 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
- Diagnosis of Alzheimer's disease, other dementia, or major neurologic diseases like Parkinson's or seizure disorder
- Severe major depression or significant psychiatric disorders
- Unstable heart disease or other severe medical conditions
- History of atrial fibrillation with symptoms or certain medications
- Very high blood pressure (SBP ≥ 180 mmHg or DBP ≥ 110 mmHg)
- Orthostatic hypotension with low standing systolic BP
- Significant autoimmune disorders
- Recent history of alcoholism or drug abuse
- Uncontrolled diabetes with high hemoglobin A1C or insulin use
- Smoking cigarettes within the past year
- Presence of pacemaker or metal device preventing MRI
- Women of childbearing potential unless surgically sterile or 2 years post-menopausal
- Participation in another investigational drug or device study within 2 months
- Severe obesity with BMI over 40
- Allergies to angiotensin receptor blockers or amlodipine
- Abnormal lab tests such as liver or kidney issues
- Medical condition likely limiting survival to less than 3 years
- Conditions judged to interfere with study participation, including plans to move, lack of support, transportation issues, nursing home residency, or living with a study partner
- Couples or significant partners living together cannot participate simultaneously
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 months
Participants receive either intensive pharmacological treatment to lower systolic blood pressure below 120 mmHg or follow their primary care provider's recommendations for blood pressure control.
Regular visits throughout 24 months for blood pressure management and assessments
Duration - Up to 24 months after treatment initiation
Participants continue to be monitored for changes in brain amyloid and tau protein deposition, cerebral blood flow, brain volume, neural connectivity, and cognitive performance after the treatment period.
Follow-up visits coincide with treatment visits for assessments at baseline, 12 months, and 24 months
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
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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