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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 Wanpen Vongpatanasin, MD
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 months, 24 months
Awards & highlights
IPAT Trial 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.Check my eligibility
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.See study design
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.
IPAT Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change From Baseline in Brain Fibrillar Beta-Amyloid Protein (Aβ)
Secondary outcome measures
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 moreIPAT 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
1,674 Previous Clinical Trials
28,020,725 Total Patients Enrolled
Texas Health ResourcesOTHER
14 Previous Clinical Trials
19,960 Total Patients Enrolled
Rong ZhangLead Sponsor
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there restrictions on who is eligible to participate in this research?
"This hypertension clinical trial, which will have a total of 180 enrollees, is looking for participants that are aged 60 to 80."
Answered by AI
Are we able to sign people up for this research project at this time?
"The trial, which was originally advertised on November 1st, is still looking for participants according to the clinicaltrials.gov website."
Answered by AI
How many individuals are being monitored in this experiment?
"That is correct. As of today, the clinical trial listed on clinicaltrials.gov is still recruiting patients that meet the eligibility criteria. The study was originally posted on November 1st, 2020 and was updated October 21st, 2020. They are looking for a total of 180 participants at 1 location."
Answered by AI
Does this experiment only allow young adults as participants?
"If you are between the ages of 60 to 80, you meet the age requirements for this clinical trial."
Answered by AI
Are ARBs and CCBs safe for general use?
"While Phase 2 trials are promising, there is currently a lack of data supporting Angiotensin II Receptor Blockers (ARBs, losartan) and Calcium Channel Blockers (CCB, amlodipine)."
Answered by AI
Who else is applying?
What site did they apply to?
University of Texas Southwestern Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
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