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Adrenergic Blocker

Carvedilol for Parkinson's Disease

Phase 2

Waitlist Available

Led By Michele L Lima Gregorio, MD, FAAN

Research Sponsored by Cedars-Sinai Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Capacity to give informed consent

Be older than 18 years old

Must not have

Asthma or bronchospasm

Allergy/hypersensitivity to iodine or study medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Approved for 10 Other Conditions

Summary

This trial will investigate the long-term effects of treatment with the adrenergic blocker carvedilol on dopamine transporter (DAT) single photon emission computerized tomography (SPECT) imaging in people with defined pre-motor Parkinson's disease risks.

Who is the study for?

This trial is for people with early Parkinson's Disease who may also have REM Sleep Behavior Disorder and other pre-motor symptoms but do not suffer from severe depression or conditions like recent heart attacks, diabetes, certain heart blocks, cardiomyopathy, pericarditis, severe sleep apnea, low heart rates with symptoms, stroke within the last month, severe liver dysfunction or failure. Participants must be able to consent and should not be on beta-blockers.

What is being tested?

The study tests the long-term effects of Carvedilol (a medication that affects the body's response to nerve impulses in certain parts of the body) on brain imaging techniques in patients at risk for Parkinson’s disease. It focuses on changes observed through DaTscan SPECT imaging and MIBG scintigraphy.

What are the potential side effects?

While specific side effects are not listed here for Carvedilol in this context, common ones include dizziness due to lowered blood pressure, fatigue, weight gain due to fluid retention and slower heartbeat. Patients might also experience digestive issues or shortness of breath.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I understand the details of the clinical trial and can consent to participate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have asthma or experience bronchospasm.

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I am allergic to iodine or the medication used in this study.

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I am currently taking beta-blocker medication.

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I have severe depression, with a BDI score over 13.

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I have chronic atrial fibrillation.

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My heart's pumping ability is reduced (LVEF <45%).

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I have diabetes.

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My heart rate is very low and I have symptoms like dizziness or shortness of breath.

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I have a severe narrowing of the aortic valve in my heart.

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My blood pressure is higher than 150/100 mmHg.

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I have severe sleep apnea that hasn't been treated, with an AHI over 30.

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My kidney function is severely reduced.

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I have frequent chest pain due to heart problems.

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I cannot take carvedilol due to health reasons.

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I have not had a heart attack in the last 48 hours.

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I have a type of heart block.

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I have a heart condition that restricts its ability to pump blood.

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I have COPD.

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I have had a severe heart condition causing very low blood pressure.

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I have Parkinson's disease symptoms not caused by primary Parkinson's.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every year for three years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every year for three years

This trial's timeline: 3 weeks for screening, Varies for treatment, and every year for three years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in 123I-Ioflupane uptake - DATscan

Secondary study objectives

Changes in 123I-MIBG WR rate

Changes in 123I-MIBG late H/M

Diagnosis of PD or other synucleinopathies by the end of 3 years in the study population

+1 more

Other study objectives

Central and peripheral insulin resistance changes

Color vision changes

Correlation between changes in integrity of pigmented neurons of substantia nigra as measured by neuromelanin-sensitive magnetic resonance imaging (MRI) and 123I-Ioflupane uptake as measured by Dopamine Transporter Imaging (DAT scan)

+8 more