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

36 Participants Needed

Trial Summary

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.

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, and its use in cerebrovascular disease is novel. Unlike other treatments that focus on blood thinning or improving blood flow, Prazosin works by relaxing blood vessels, which may help reduce blood pressure and improve blood flow in the brain. ^{1 2 3 4 5}

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 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

I am between 55 and 69 years old.

Nonsmoker

Exclusion Criteria

I have a history of serious heart disease.

I have had major surgery in the past.

My blood pressure is not controlled by medication.

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. India pubmed.ncbi.nlm.nih.gov

A randomized double-blind controlled study of nimodipine in acute cerebral ischemic stroke. [2013]

2. Italy pubmed.ncbi.nlm.nih.gov

[Ischemic cerebrovascular disease: treatment with various anti-platelet aggregation drugs. Clinical follow-up of 80 patients (22-34 months)]. [2013]

3. England pubmed.ncbi.nlm.nih.gov

Pentoxifylline reduces injury of the brain in transient ischaemia. [2017]

4. Australia pubmed.ncbi.nlm.nih.gov

Pentoxifylline in the treatment of acute ischaemic stroke--a reappraisal in Chinese stroke patients. [2022]

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

Preventing cognitive decline and dementia from cerebral small vessel disease: The LACI-1 Trial. Protocol and statistical analysis plan of a phase IIa dose escalation trial testing tolerability, safety and effect on intermediary endpoints of isosorbide mononitrate and cilostazol, separately and in combination. [2022]