Cognitively Normal Older AdultsPhase 2IPATNCT05331144
Impact of Intensive Treatment of SBP on Brain Perfusion, Amyloid, and Tau (IPAT Study)
A Phase 2 study testing Angiotensin II Receptor Blockers (ARBs, losartan) and Calcium Channel Blockers (CCB, amlodipine) and PCP in people with Cognitively Normal Older Adults and Hypertension, run by Rong Zhang at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Cognitively Normal Older Adults, Hypertension, Subjective Cognitive Decline
- What is being tested?
- Angiotensin II Receptor Blockers (ARBs, losartan) and Calcium Channel Blockers (CCB, amlodipine) and PCP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2022to 31 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Clinically documented history of stroke, focal neurological signs or other major cerebrovascular diseases based on clinical judgment or MRI/CT scans such as evidence of infection, infarction, or other brain lesions;
- Diagnosis of AD or other type of dementia, or significant neurologic diseases such as Parkinson's disease, seizure disorder, multiple sclerosis, history of severe head trauma or normal pressure hydrocephalus;
- Evidence of severe major depression (GDS ≥ 12, may be rescreened after 12 weeks or longer if evidence of reactive depression or temporary mood disturbances) or clinically significant psychopathology, (e.g., psychosis and schizophrenia); if hospitalized in past year, can be rescreened in 6 months; or presence of a major psychiatric disorder that in the investigator's opinion, could interfere with adherence to research assessments or procedures.
- Unstable heart disease based on clinical judgment (e.g., heart attack/cardiac arrest, cardiac bypass procedures within previous 6 months and congestive heart failure), or other severe medical conditions;
- History of atrial fibrillation and evidence on ECG with any of the following: active symptoms of persistent palpitation, dizziness, history of syncope, chest pain, dyspnea, orthopnea, shortness of breath at rest, or paroxysmal nocturnal dyspnea within the past 6 months; resting heart rate of < 30 or > 110 bpm; taking class I or III antiarrhythmic drugs including flecainide, propafenone, dronedarone, sotalol, dofetilide, and amiodarone; or clinical concerns for safely participating in lowering blood pressure.
- Systolic BP equal or greater than 180 mmHg and/or diastolic BP equal or greater than 110 mmHg, may be rescreened in 1 week.
Show all 26Show fewer
- Orthostatic hypotension, defined as the third standing SBP < 100mmHg, may be rescreened after 2 weeks;
- History of significant autoimmune disorders such as systemic lupus erythematosus, rheumatoid arthritis or polymyalgia rheumatica;
- Significant history of alcoholism or drug abuse within the last five years;
- Uncontrolled diabetes mellitus, defined as hemoglobin A1C > 7.5%, or requiring insulin treatment;
- Regularly smoking cigarettes within the past year;
- Pacemaker or other medical device of metal that precludes performing MRI;
- Women with a potential for pregnancy, lactation/childbearing (2 year post-menopausal or surgically sterile to be considered not childbearing potential);
- Participant enrolled in another investigational drug or device study, either currently or within the past 2 months;
- Severe obesity with BMI > 40 ; clinical judgment should be applied in all cases to assess patient safety and anticipated compliance;
- Allergy to angiotensin receptor blockers (ARBs), i.e., drugs that have a suffix "-sartan"; allergy to amlodipine;
- Abnormal screening laboratory tests (e.g., liver ALT and AST > 3 x ULN, GFR < 30 or Hct < 28%); may be rescreened after 2 weeks or longer;
- A medical condition likely to limit survival to less than 3 years;
- Participant has any condition(s) judged by the study investigator to be medically inappropriate, risky or likely to cause poor study compliance. For example:
- Plans to move outside the clinic catchment area in the next 2 years;
- Significant concerns about participation in the study from spouse, significant other, or family members;
- Lack of support from primary health care provider;
- Residence too far from the study clinic site such that transportation is a barrier including persons who require transportation assistance provided by the study clinic funds for screening or randomization visits;
- Residence in a nursing home; persons residing in an assisted living or retirement community are eligible if they meet the other criteria;
- Other medical, psychiatric, or behavioral factors that, in the judgment of the site PI or clinician, may interfere with study participation or the ability to follow the study Protocol.
- Couples or significant partners who live together cannot be enrolled or participate simultaneously in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
About this study
Official title: Impact of Intensive Treatment of Systolic Blood Pressure on Brain Perfusion, Amyloid, and Tau in Older Adults (IPAT Study)
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.
Read the detailed description
The IPAT study is a 2-arm open-label randomized controlled trial to assess the effects of intensive pharmacological reduction of high blood pressure (SBP) on brain amyloid and tau protein deposition (Alzheimer's Disease pathology) in older adults who are at high risk for AD and related dementias, that is, those who have high blood pressure, family history of dementia, or subjective memory complaints. Furthermore, IPAT will examine effects of intensive blood pressure lowering on brain volume, perfusion, and neural network connectivity using magnetic resonance imaging (MRI) and cognitive performance.
- Conditions
- Cognitively Normal Older Adults, Hypertension, Subjective Cognitive Decline, Family History of Dementia
- Being tested
- Angiotensin II Receptor Blockers (ARBs, losartan) and Calcium Channel Blockers (CCB, amlodipine), PCP
- Keywords
- Dementia, Alzheimer's Disease, Cognitive Function, Blood Pressure, Amyloid, Tau
- Medical subject headings
- Hypertension, Dementia, Alzheimer Disease, Pick Disease of the Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiotensin II Receptor Blockers (ARBs, losartan) and Calcium Channel Blockers (CCB, amlodipine)Drug
Angiotensin II Receptor Blockers (ARBs, losartan) and Calcium Channel Blockers (CCB, amlodipine) will be used to treat high blood pressure. Additional antihypertensive medications may be used if needed.
PCPOther
Participants will follow their PCP's recommendations for BP control.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Treatment (IT) | Experimental | Lowering SBP < 120 mmHG Receives: Drug: Angiotensin II Receptor Blockers (ARBs, losartan) and Calcium Channel Blockers (CCB, amlodipine) |
| Usual Care (UC) | Active comparator | Participants will follow their PCP's recommendations for BP control Receives: Other: PCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Brain Fibrillar Beta-Amyloid Protein (Aβ)
Brain Aβ will be measured by annual change of amyloid mean cortical standardized uptake value ratio (SUVR) with positron emission tomography (PET).
Measured: Baseline, 24 months
Secondary outcomes (8)
Change From Baseline in Brain Tau Deposition
Brain Tau Deposition will be measured by tau temporal meta-ROI composite with positron emission tomography (PET).
Measured: Baseline, 24 months
Change From Baseline in regional Cerebral Blood Flow (CBF)
Regional CBF will be measured by MRI using arterial spin labeling.
Measured: Baseline, 12 months, 24 months
Change From Baseline in global Cerebral Blood Flow (CBF)
Global CBF will be measured by PC-MRI and 2D color-coded duplex ultrasonography.
Measured: Baseline, 12 months, 24 months
Change From Baseline in Arterial Stiffness
Central arterial stiffness (pulse wave velocity and carotid β-stiffness index) will be measured by artery applanation tonometry.
Measured: Baseline, 12months, 4 months
Change From Baseline in Amplitude of Low Frequency Fluctuations of Blood-Oxygen-Level-Dependent Signal (BOLD ALFF)
BOLD ALFF will be measured by resting state functional MRI (rs-fMRI).
Measured: Baseline, 12 months, 24 months
Change From Baseline in White Matter Hyperintensity Volume
White matter hyperintensity volume will be measured by MRI using 3D T2 FLAIR sequence .
Measured: Baseline, 12 months, 24 months
Change From Baseline in Brain Neural Network Connectivity
Brain neural network connectivity will be measured by rs-fMRI.
Measured: Baseline, 12 months, 24 months
Change From Baseline in Neurocognitive Function
A composite z score will be obtained by conversion of individual test scores of the Preclinical Alzheimer Cognitive Composite (PACC) and the NIH Toolbox Cognition Battery to standardized z scores, then averaged to assess changes in global cognitive function. Domain-specific z scores will be used to assess specific domains of cognitive function (i.e., memory, executive function, language etc.).
Measured: Baseline, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start25 Oct 2022
- Primary completion1 Jun 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitively Normal Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rong Zhang
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Texas Health Resources, Michigan State University
- Responsible party
- Sponsor-investigator, Rong Zhang, University of Texas Southwestern Medical Center
- Investigators
- Rong Zhang, PhD, Principal investigator, University of Texas Southwestern Medical CenterWanpen Vongpatanasin, MD, Principal investigator, University of Texas Southwestern Medical CenterDavid Zhu, PhD, Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05331144
- Sponsor's protocol ID
- STU-2021-1210
- Other IDs
- 1R01AG076660-01
- Acronym
- IPAT
- Status last verified
- Jul 2026
- First submitted
- 8 Apr 2022
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intensive Treatment of Systolic Blood Pressure on Brain Perfusion, Amyloid, and Tau in Older Adults (IPAT Study)
- ClinicalTrials.gov ID
- NCT05331144
- Acronym / sponsor ID
- IPAT / STU-2021-1210
- Conditions
- Cognitively Normal Older Adults, Hypertension, Subjective Cognitive Decline, Family History of Dementia
- Keywords
- Dementia, Alzheimer's Disease, Cognitive Function, Blood Pressure, Amyloid, Tau
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Rong ZhangUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Texas Health Resources, Michigan State University
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The IPAT study is a 2-arm open-label randomized controlled trial to assess the effects of intensive pharmacological reduction of high blood pressure (SBP) on brain amyloid and tau protein deposition (Alzheimer's Disease pathology) in older adults who are at high risk for AD and related dementias, that is, those who have high blood pressure, family history of dementia, or subjective memory complaints. Furthermore, IPAT will examine effects of intensive blood pressure lowering on brain volume, perfusion, and neural network connectivity using magnetic resonance imaging (MRI) and cognitive performance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Treatment (IT) | Experimental | Drug: Angiotensin II Receptor Blockers (ARBs, losartan) and Calcium Channel Blockers (CCB, amlodipine)Lowering SBP < 120 mmHG |
| Usual Care (UC) | Active comparator | Other: PCPParticipants will follow their PCP's recommendations for BP control |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (26 listed)
- Clinically documented history of stroke, focal neurological signs or other major cerebrovascular diseases based on clinical judgment or MRI/CT scans such as evidence of infection, infarction, or other brain lesions;
- Diagnosis of AD or other type of dementia, or significant neurologic diseases such as Parkinson's disease, seizure disorder, multiple sclerosis, history of severe head trauma or normal pressure hydrocephalus;
- Evidence of severe major depression (GDS ≥ 12, may be rescreened after 12 weeks or longer if evidence of reactive depression or temporary mood disturbances) or clinically significant psychopathology, (e.g., psychosis and schizophrenia); if hospitalized in past year, can be rescreened in 6 months; or presence of a major psychiatric disorder that in the investigator's opinion, could interfere with adherence to research assessments or procedures.
- Unstable heart disease based on clinical judgment (e.g., heart attack/cardiac arrest, cardiac bypass procedures within previous 6 months and congestive heart failure), or other severe medical conditions;
- History of atrial fibrillation and evidence on ECG with any of the following: active symptoms of persistent palpitation, dizziness, history of syncope, chest pain, dyspnea, orthopnea, shortness of breath at rest, or paroxysmal nocturnal dyspnea within the past 6 months; resting heart rate of < 30 or > 110 bpm; taking class I or III antiarrhythmic drugs including flecainide, propafenone, dronedarone, sotalol, dofetilide, and amiodarone; or clinical concerns for safely participating in lowering blood pressure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Angiotensin II Receptor Blockers (ARBs, losartan) and Calcium Channel Blockers (CCB, amlodipine)Angiotensin II Receptor Blockers (ARBs, losartan) and Calcium Channel Blockers (CCB, amlodipine) will be used to treat high blood pressure. Additional antihypertensive medications may be used if needed. | Drug | Intensive Treatment (IT) |
| PCPParticipants will follow their PCP's recommendations for BP control. | Other | Usual Care (UC) |
Primary outcome
Change From Baseline in Brain Fibrillar Beta-Amyloid Protein (Aβ)
Time frame: Baseline, 24 months
Brain Aβ will be measured by annual change of amyloid mean cortical standardized uptake value ratio (SUVR) with positron emission tomography (PET).
8 secondary outcomes
Change From Baseline in Brain Tau Deposition
Time frame: Baseline, 24 months
Change From Baseline in regional Cerebral Blood Flow (CBF)
Time frame: Baseline, 12 months, 24 months
Change From Baseline in global Cerebral Blood Flow (CBF)
Time frame: Baseline, 12 months, 24 months
Change From Baseline in Arterial Stiffness
Time frame: Baseline, 12months, 4 months
Change From Baseline in Amplitude of Low Frequency Fluctuations of Blood-Oxygen-Level-Dependent Signal (BOLD ALFF)
Time frame: Baseline, 12 months, 24 months
Change From Baseline in White Matter Hyperintensity Volume
Time frame: Baseline, 12 months, 24 months
Change From Baseline in Brain Neural Network Connectivity
Time frame: Baseline, 12 months, 24 months
Change From Baseline in Neurocognitive Function
Time frame: Baseline, 12 months, 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rong Zhang, PhD principal investigator
University of Texas Southwestern Medical Center
Wanpen Vongpatanasin, MD principal investigator
University of Texas Southwestern Medical Center
David Zhu, PhD principal investigator
Michigan State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Angiotensin II Receptor Blockers (ARBs, losartan) and Calcium Channel Blockers (CCB, amlodipine) and PCP in people with Cognitively Normal Older Adults and Hypertension, run by Rong Zhang at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Brain Fibrillar Beta-Amyloid Protein (Aβ) (time frame: Baseline, 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.