Impact of Intensive Treatment of Systolic Blood Pressure on Brain Perfusion, Amyloid, and Tau in Older Adults (IPAT Study)

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 85
Healthy Volunteers: f
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• Age 60-85, all races/ethnicities, and both sexes are eligible;

• Mini-Mental State Exam (MMSE) ≥ 26 to exclude gross dementia; based on clinical judgment, may be rescreened in ≥ 7 days;

• Individuals with SBP ≥ 130 and SBP ≤ 180 if on 0 or 1 antihypertensive medications; ≥130 and ≤170 on up to 2 medications; ≥130 and ≤160 on up to 3 medications; ≥130 and ≤150 on up to 4 medications. Those on antihypertensives are eligible. If an individual, not treated for hypertension (HTN), has a SBP ≥ 125 mmHg, consider rescreening after 24 hours;

• Willingness to be randomized into the treatment groups and ability to return to clinic for follow-up visits over 24 months;

• Fluency in English or Spanish or both, adequate visual and auditory acuity to allow neuropsychological testing;

• Participants must have a regular healthcare provider.

Locations
United States
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Contact Information
Primary
Tristyn Hall-Curtis, MBA
TristynHall@texashealth.org
2143454245
Time Frame
Start Date: 2022-10-25
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 180
Treatments
Experimental: Intensive Treatment (IT)
Lowering SBP \< 120 mmHG
Active_comparator: Usual Care (UC)
Participants will follow their PCP's recommendations for BP control
Sponsors
Leads: Rong Zhang
Collaborators: National Institute on Aging (NIA), Michigan State University, Texas Health Resources

This content was sourced from clinicaltrials.gov