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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
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:Select...
My partner and I cannot both join this study at the same time.
Select...
I have been diagnosed with a significant neurological condition like Alzheimer's, Parkinson's, or MS.
Select...
I have a history of stroke or major brain issues confirmed by scans.
Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 12 months, 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 months, 24 months
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 moreTrial 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
1,733 Previous Clinical Trials
28,054,823 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not currently pregnant, breastfeeding, and either over 2 years post-menopausal or surgically sterile.My family has significant concerns about me joining the study.You need to have a Mini-Mental State Exam (MMSE) score of 26 or higher to make sure you don't have severe memory and thinking problems.My blood pressure fits the trial's criteria, and I take a certain number of blood pressure medications.My partner and I cannot both join this study at the same time.My blood pressure is between 130 and 180, even if I'm taking medication for it.I have been diagnosed with a significant neurological condition like Alzheimer's, Parkinson's, or MS.I have low blood pressure when standing, but can be rechecked in 2 weeks.I have a history of stroke or major brain issues confirmed by scans.I do not have severe depression or major psychiatric disorders that could affect my participation.My diabetes is not under control, with A1C over 7.5% or I need insulin.I do not have severe heart disease or other serious health issues.I am between 60 and 85 years old.I have atrial fibrillation with symptoms or concerns that affect my heart's rhythm and treatment.I am between 60 and 80 years old.I have a family member with Alzheimer's or another type of dementia.You have memory problems and have answered "yes" to certain questions about it.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care (UC)
- Group 2: Intensive Treatment (IT)
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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