Phase 2
N=85
Hypertension, Intracranial Pulsatility and Brain Amyloid-beta Accumulation in Older Adults (HIPAC Trial)
Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT03354143 ↗Enrolled (actual)
85
Serious AEs
0.0%
Results posted
Jul 2025
Primary outcome: Primary: Changes in Gray Matter Intracranial Pulsatility — -0.09; 0.02 mm/cardiac cycle
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Standard Care (Other); Intensive Treatment (Other)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Gray Matter Intracranial Pulsatility |
-0.09; 0.02 | — |
| SECONDARY Changes in Overall Average 24 Hour Systolic Blood Pressure |
17.9; 23.6 | — |
| SECONDARY Changes in Overall Average 24hr Diastolic Blood Pressure |
10.9; 12 | — |
| SECONDARY Regional Cortical Thickness Via Magnetic Resonance Imaging (MRI) |
2.3; 2.4; 2.3; 2.3 | — |
| SECONDARY Brain White Matter Hyperintensity (WMH) Via Magnetic Resonance Imaging (MRI) |
7.9; 2.8; 7.5; 2.6 | — |
| SECONDARY Brain White Matter Microstructural Integrity Via Magnetic Resonance Imaging (MRI) |
0.4; 0.4; 0.4; 0.4 | — |
| SECONDARY Brain Neural Network Functional Connectivity Via Magnetic Resonance Imaging (MRI) |
0.39; 0.42; 0.39; 0.4 | — |
| SECONDARY NIH PROMIS Patient-reported Outcome Measures of Physical Health |
52.1; 51.0; 50.9; 51.8 | — |
| SECONDARY NIH PROMIS Patient-reported Outcome Measures of Mental Health |
56.0; 52.1; 54.9; 54.0 | — |
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT03354143). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.