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Angiotensin II Receptor Blockers and Calcium Channel Blockers

Intensive Blood Pressure Management for Dementia (IPAT Trial)

Phase 2
Recruiting
Led By Rong Zhang, PhD
Research Sponsored by Rong Zhang
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Couples or significant partners who live together cannot be enrolled or participate simultaneously in the study
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 months, 24 months
Awards & highlights
No Placebo-Only Group
Approved for 5 Other Conditions

Summary

This trial will study whether lowering blood pressure can reduce Alzheimer's disease pathology.

Who is the study for?
This trial is for adults aged 60-80 concerned about memory decline or dementia, with a family history of the condition and normal to mildly impaired cognitive function. Participants must have high blood pressure but not severe enough to require immediate crisis management, be willing to follow the study protocol for two years, and cannot be pregnant or have major neurological diseases.
What is being tested?
The IPAT Study tests whether intensive treatment using FDA-approved blood pressure medications (losartan and amlodipine) can reduce Alzheimer's-related brain changes in older adults at risk of dementia. The focus is on lowering systolic blood pressure to see if it affects amyloid and tau protein buildup in the brain.
What are the potential side effects?
Potential side effects from losartan may include dizziness, muscle cramps, nasal congestion while amlodipine might cause swelling in legs or ankles, fatigue, stomach pain. Side effects vary by individual; some people may experience none.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My partner and I cannot both join this study at the same time.
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I have been diagnosed with a significant neurological condition like Alzheimer's, Parkinson's, or MS.
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I have a history of stroke or major brain issues confirmed by scans.
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My diabetes is not under control, with A1C over 7.5% or I need insulin.
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I do not have severe heart disease or other serious health issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 months, 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 months, 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in Brain Fibrillar Beta-Amyloid Protein (Aβ)
Secondary study objectives
Change From Baseline in Amplitude of Low Frequency Fluctuations of Blood-Oxygen-Level-Dependent Signal (BOLD ALFF)
Change From Baseline in Arterial Stiffness
Change From Baseline in Brain Neural Network Connectivity
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intensive Treatment (IT)Experimental Treatment1 Intervention
Lowering SBP \< 120 mmHG
Group II: Usual Care (UC)Active Control2 Interventions
Participants will follow their PCP's recommendations for BP control

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH
1,789 Previous Clinical Trials
28,188,152 Total Patients Enrolled
Texas Health ResourcesOTHER
15 Previous Clinical Trials
20,029 Total Patients Enrolled
Rong ZhangLead Sponsor
1 Previous Clinical Trials
40 Total Patients Enrolled

Media Library

Losartan and Amlodipine (Angiotensin II Receptor Blockers and Calcium Channel Blockers) Clinical Trial Eligibility Overview. Trial Name: NCT05331144 — Phase 2
High Blood Pressure Research Study Groups: Usual Care (UC), Intensive Treatment (IT)
High Blood Pressure Clinical Trial 2023: Losartan and Amlodipine Highlights & Side Effects. Trial Name: NCT05331144 — Phase 2
Losartan and Amlodipine (Angiotensin II Receptor Blockers and Calcium Channel Blockers) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05331144 — Phase 2
~98 spots leftby Jun 2027
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