Prazosin for Cerebrovascular Disease

Overseen By Anna Howery

Age: 18+

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

Compensation: Varies

Number of Visits: 2

Duration: Up to 240 minutes

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effects of the drug prazosin on brain blood flow. Researchers aim to observe how prazosin affects blood flow during specific tests, such as posture changes and inhaling extra carbon dioxide. Participants will receive either prazosin or a placebo (a harmless pill with no active drug) to compare results. The trial seeks nonsmoking, postmenopausal women and men aged 55 to 69, with a BMI of 34.5 or lower, and shorter than 6 feet. As a Phase 2 trial, this research measures prazosin's effectiveness in an initial, smaller group, allowing participants to contribute to important medical advancements.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications, but it does exclude those taking medications that interfere with prazosin. It's best to discuss your current medications with the trial team.

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

Research has shown that prazosin is generally safe for use. Doctors often prescribe it for high blood pressure, PTSD-related nightmares, and other conditions. The most common side effect is a racing heart, occurring in about 5% of users. Some may also experience dizziness or faintness, especially when standing up quickly. These side effects are usually mild, but awareness is important. Since the FDA has already approved prazosin for other uses, extensive safety information is available. However, individual experiences can vary, so discussing any concerns with a healthcare provider is always advisable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cerebrovascular disease?

Prazosin is unique because it offers a new approach to treating cerebrovascular disease by primarily focusing on managing blood pressure, a key risk factor for the condition. Unlike traditional treatments that might use anticoagulants or antiplatelet agents to prevent blood clots, prazosin is an alpha-blocker that works by relaxing blood vessels, potentially leading to improved blood flow in the brain. Researchers are excited about prazosin because its mechanism of action might help in reducing the risk of strokes in middle-aged adults, offering a different strategy compared to existing therapies.

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

Research has shown that prazosin can help increase blood flow to the brain. One study demonstrated that a single dose of prazosin led to a small but noticeable increase in brain blood flow. By lowering blood pressure, prazosin might also reduce the risk of stroke over time. Additionally, prazosin has been found to protect certain cells in the body from damage and reduce inflammation. These effects suggest that prazosin could improve brain blood flow and potentially aid conditions related to blood flow issues in the brain. Participants in this trial will receive either prazosin or a placebo to evaluate these potential benefits. ^{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 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.

Inclusion Criteria

Have a BMI ≤34.5 kg/m2

Nonsmoker

I am between 55 and 69 years old.

Exclusion Criteria

I have a history of serious heart disease.

My blood pressure is not controlled by medication.

I have had major surgery in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo simulated postural change tests and breathe increased levels of carbon dioxide while MRI measures changes in cerebral blood flow and velocity

Up to 240 minutes

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Prazosin

Trial Overview 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.

How Is the Trial Designed?

Group I: Middle-Aged Adults Experimental Treatment 3 Interventions

Middle-Aged Adults between 55-69 years of age.

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

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.