Prazosin + MRI for Cerebrovascular Disease

Overseen By Anna Howery

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Wisconsin, Madison

Must not be taking: Prazosin

Disqualifiers: MCI, Alzheimer's, Cardiovascular, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

36 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on medications that interfere with prazosin.

What data supports the effectiveness of the drug Prazosin (Minipress) for cerebrovascular disease?

Research shows that Prazosin can increase cerebral blood flow in patients with high blood pressure, which might be beneficial for cerebrovascular conditions. Additionally, Prazosin is effective in treating hypertension and heart failure, suggesting it could help manage related symptoms in cerebrovascular disease. ^{1 2 3 4 5}

How does the drug Prazosin differ from other treatments for cerebrovascular disease?

Prazosin is unique because it is primarily used to treat high blood pressure and PTSD-related nightmares, but its use in cerebrovascular disease is novel, potentially offering benefits through its effects on blood flow and pressure. This trial also combines Prazosin with MRI, which may help in better understanding and monitoring the disease. ^{6 7 8 9 10}

What is the purpose of this trial?

Brain blood flow will be measured during a simulated postural change test and while breathing increased levels of carbon dioxide using magnetic resonance imaging.

Eligibility Criteria

This trial is for healthy nonsmokers aged 20-40 with a BMI ≤34.5 kg/m2. It's not for those with major neurological disorders, psychiatric conditions, cardiovascular diseases, contraindications to MRI, severe sleep apnea, uncontrolled diabetes or hypertension, certain medication use, or significant surgical history.

Inclusion Criteria

Nonsmoker

Have a BMI ≤34.5 kg/m2

I am between 20 and 40 years old.

Exclusion Criteria

I do not have major neurological disorders besides dementia.

Current or recent (<1 year) major psychiatric condition (Axis I) or addictive disorders

I have a history of serious heart conditions.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Acute Physiological Challenge

Participants undergo simulated postural change test and breathing increased levels of carbon dioxide while MRI measures cerebrovascular responses

Up to 240 minutes

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the acute physiological challenge

4 weeks

Treatment Details

Interventions

• Prazosin

Trial Overview The study tests how the drug Prazosin affects brain blood flow during simulated postural changes and high carbon dioxide levels using MRI scans. A placebo group is included for comparison.

Participant Groups

Group I: Young Adults Experimental Treatment 3 Interventions

Young Adults between 20-40 years of age.

Prazosin is already approved in United States for the following indications:

Approved in United States as Minipress for:

• Hypertension
• Benign prostatic hypertrophy
• Posttraumatic stress disorder (PTSD) nightmares and hyperarousal symptoms

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Findings from Research

In a study of 24 outpatients with uncontrolled hypertension, prazosin effectively lowered blood pressure, achieving normotensive levels in 9 out of 24 patients, demonstrating its efficacy in treating severe hypertension.

Prazosin was generally well-tolerated, with a low incidence of side effects, primarily postural hypotension, which affected 3 patients and led to their withdrawal from the trial, indicating a need for monitoring in some individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prazosin in the therapy of uncontrolled hypertension. Lubbe, WF.[2014]

Prazosin is an effective treatment for hypertension and congestive heart failure, providing sustained antihypertensive effects without significantly increasing heart rate or plasma norepinephrine levels, making it a safer option compared to other medications.

While postural hypotension can occur after the first dose, most side effects are mild and do not limit therapy, and long-term use has shown continued effectiveness and improvement in symptoms, even during exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alpha-adrenergic receptor blockade with prazosin. Consideration of hypertension, heart failure, and potential new applications. Colucci, WS.[2019]

Gadolinium contrast agents, including gadopentetate dimeglumine, gadodiamide, and gadoteridol, significantly enhance the diagnostic capabilities of MRI for brain and spine imaging, providing critical information that helps confirm or rule out conditions.

These agents are extremely safe and well-tolerated, with generally mild side effects, making them a reliable choice in clinical practice for improving diagnostic confidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR imaging advances in practice. Drayer, BP.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Measurement of the effects of a single dose of prazosin on the cerebral blood flow in hypertensive patients. [2019]

2. Hungary pubmed.ncbi.nlm.nih.gov

The mechanism of the action of Minipress. Examinations in hypertension. [2013]

3. South Africa pubmed.ncbi.nlm.nih.gov

Prazosin in the therapy of uncontrolled hypertension. [2014]

4. United States pubmed.ncbi.nlm.nih.gov

Cardiovascular consequences of primary antihypertensive therapy with prazosin hydrochloride. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Alpha-adrenergic receptor blockade with prazosin. Consideration of hypertension, heart failure, and potential new applications. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Unilateral hypoxic-ischemic injury in the neonatal rat brain evaluated by in vivo MRI. Correlation with histopathology and neuroprotection by MK-801. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

MR imaging advances in practice. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Repeat cerebral blood volume assessment with first-pass MR imaging. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Cerebral MR perfusion imaging: first clinical application of a 1 M gadolinium chelate (Gadovist 1.0) in a double-blinded randomized dose-finding study. [2019]

10. Germany pubmed.ncbi.nlm.nih.gov

[Multicenter analysis of tolerance and clinical safety of the extracellular MR contrast agent gadobenate dimeglumine (MultiHance)]. [2015]