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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how prazosin, an alpha-blocker, affects blood flow in the brain, particularly during changes in body position or increased carbon dioxide levels. Researchers aim to determine if prazosin can improve blood flow in individuals with cerebrovascular disease, which impacts the brain's blood vessels. Participants should be non-smokers, aged 20-40, with a healthy weight and no history of serious heart or brain conditions. Those meeting the criteria may find this trial suitable. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to significant medical advancements.

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.

Is there any evidence suggesting that Prazosin is likely to be safe for humans?

Research has shown that prazosin often treats high blood pressure, nightmares related to PTSD, and some circulation problems, indicating it is usually well-tolerated. However, like any medication, prazosin can cause side effects. About 5% of people may experience palpitations, where the heart beats fast or irregularly. Fainting can also occur, especially when starting the medication or increasing the dose. Prazosin's long history of use provides reassurance about its safety. It's important to consider individual health conditions and discuss them with a doctor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for cerebrovascular disease focus on reducing symptoms or preventing further vascular damage through anticoagulants or antiplatelet agents. But Prazosin works differently, targeting the nervous system to potentially reduce blood pressure spikes and improve blood flow. Researchers are excited because Prazosin, commonly used for hypertension and PTSD, may offer a novel approach by addressing the neurological aspects of cerebrovascular conditions. This could provide a new avenue for managing these diseases, particularly in young adults, by offering benefits that standard treatments do not.

What evidence suggests that Prazosin might be an effective treatment for cerebrovascular disease?

Research has shown that prazosin, a medication commonly used to lower blood pressure, can also affect blood flow to the brain. One study found that prazosin significantly lowered blood pressure and slightly increased brain blood flow. This is important because better blood flow can help protect the brain from damage and may lower the risk of stroke. Additionally, prazosin has been shown to reduce inflammation and protect certain cells, potentially benefiting people with conditions affecting brain blood flow. Overall, these findings suggest that prazosin might help manage conditions involving the brain's blood vessels. Participants in this trial will receive prazosin to further investigate its effects on cerebrovascular health. ^{6 7 8 9 10}

Who Is on the Research Team?

Jill Barnes, PhD

Principal Investigator

UW Madison

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/7022420/

Measurement of the effects of a single dose of prazosin ... This double-blind study showed a significant decrease in BP and a small just significant increase in cerebral blood flow following a single 1-mg dose of ...

2. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.108.529859

Effect of Prazosin on Dynamic Cerebral Autoregulation ... Prazosin directly impaired cerebral autoregulation (I would suggest it is the effect of the lower MAP per se rather than the drug).

3. droracle.ai droracle.ai/articles/99022/prazosin-induced-stroke

Is prazosin (an alpha-1 adrenergic receptor antagonist) ... In fact, by lowering blood pressure in hypertensive patients, prazosin may actually help reduce stroke risk in the long term, as supported by ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7401792/

Prazosin blocks apoptosis of endothelial progenitor cells ... The results showed that prazosin treatment decreased apoptosis of EPCs. Prazosin treatment decreased the serum expression levels of the inflammatory factors, ...

5. sciencedirect.com sciencedirect.com/science/article/pii/0002914980906566

Long-term therapy of heart failure with prazosin After 2 months, the patients treated with prazosin showed significant improvement in mean New York Heart Association functional class (3.7 ± 0.2 to 2.3 ± 0.2, p ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK555959/

Prazosin - StatPearls - NCBI Bookshelf - NIH Prazosin is a medication used to manage and treat hypertension, benign prostatic hyperplasia, PTSD-associated nightmares, and the Raynaud phenomenon.

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2013/017442s041lbl.pdf

Minipress capsules (prazosin hydrochloride) for oral use Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been ...

8. mayoclinic.org mayoclinic.org/drugs-supplements/prazosin-oral-route/description/drg-20065617

Prazosin (oral route) - Side effects & dosage Safety and efficacy have not been established. ... No information is available on the relationship of age to the effects of prazosin in geriatric ...

9. medcentral.com medcentral.com/drugs/monograph/8695-382245/prazosin-oral

Prazosin: uses, dosing, warnings, adverse events, ... Cardiovascular Effects​​ Palpitation is the most common adverse cardiovascular effect of prazosin, occurring in about 5% of patients. In addition to syncope, ...

10. drugs.com drugs.com/cons/minipress.html

Minipress Advanced Patient Information Detailed drug Information for Minipress. Includes common brand names, drug descriptions, warnings, side effects and dosing information.