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Prazosin for Cerebrovascular Disease
Phase 2
Waitlist Available
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Females must be postmenopausal
Between the ages of 55-69 years
Must not have
History of cardiovascular disease including severe congestive heart failure, coronary artery disease, ischemic heart disease (stents, coronary artery bypass grafts) and tachycardia
Uncontrolled hypertension
Timeline
Screening 3 weeks
Treatment Varies
Follow Up two study visits, up to 240 minutes
Summary
This trial will measure blood flow in the brain while participants are asked to change their posture and breathe in more carbon dioxide using a special imaging technique.
Who is the study for?
This trial is for nonsmoking individuals aged 55-69 with a BMI ≤34.5 kg/m2, who are postmenopausal if female. It's not for those with severe heart conditions, uncontrolled high blood pressure, poorly managed diabetes, significant liver or blood diseases, kidney failure requiring dialysis, dementia-related diagnoses, major psychiatric or addictive disorders in the past year, contraindications to MRI scans or medications that affect prazosin.
What is being tested?
The study measures how brain blood vessels respond to changes in flow during simulated posture change and breathing carbon dioxide-rich air using MRI. Participants will receive either Prazosin (a drug that affects blood vessel behavior) or a placebo to compare effects.
What are the potential side effects?
Prazosin may cause dizziness, headache, drowsiness; less commonly it can lead to rapid heartbeat or fainting when standing up due to lowered blood pressure. Placebo should have no active side effects but can include symptoms due to patient expectation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have gone through menopause.
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I am between 55 and 69 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of serious heart disease.
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My blood pressure is not controlled by medication.
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My diabetes is severe with HbA1c over 9.5%.
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I have been diagnosed with Mild Cognitive Impairment or Alzheimer's disease.
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I am not taking any medications that would interfere with prazosin.
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I have had a serious stroke or brain blood flow problem.
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I do not have major neurological disorders besides dementia.
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I do not have severe liver, blood, or blood vessel diseases, nor severe kidney injury requiring dialysis.
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I have severe sleep apnea that hasn't been treated.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ two study visits, up to 240 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two study visits, up to 240 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in blood flow
Change in blood velocity
Trial Design
1Treatment groups
Experimental Treatment
Group I: Middle-Aged AdultsExperimental Treatment3 Interventions
Middle-Aged Adults between 55-69 years of age.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Prazosin
2010
Completed Phase 4
~1450
MRI
2009
Completed Phase 2
~2810
Find a Location
Who is running the clinical trial?
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,373 Previous Clinical Trials
651,002 Total Patients Enrolled
5 Trials studying Magnetic Resonance Imaging (MRI)
1,510 Patients Enrolled for Magnetic Resonance Imaging (MRI)
University of Wisconsin, MadisonLead Sponsor
1,225 Previous Clinical Trials
3,168,616 Total Patients Enrolled
5 Trials studying Magnetic Resonance Imaging (MRI)
757 Patients Enrolled for Magnetic Resonance Imaging (MRI)
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