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Beta-blocker

Carvedilol for Early Parkinson's Disease

Phase 2

Recruiting

Led By Michele Tagliati, MD, FAAN

Research Sponsored by Michele Tagliati, MD

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Diabetes mellitus

Severe Hepatic Dysfunction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 3 months up to 34 weeks

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Summary

This trial will test whether the drug carvedilol can improve MIBG abnormalities in people with iRBD, who are at risk of developing Parkinson's disease.

Who is the study for?

This trial is for people aged 25-85 with REM Sleep Behavior Disorder or hyposmia, who may be at risk of developing Parkinson's Disease. They should have certain symptoms like loss of smell, constipation, depression, or abnormal heart imaging results but must not have severe heart issues, lung conditions like COPD or asthma, recent strokes or myocardial infarction, dementia, severe depression or other serious health problems.

What is being tested?

The study tests whether the beta-blocker carvedilol can reverse heart abnormalities seen in early Parkinson's disease using MIBG imaging. Carvedilol is FDA-approved for heart failure and hypertension but not yet for this specific use in Parkinson's-related disorders.

What are the potential side effects?

Carvedilol may cause dizziness, fatigue, low blood pressure when standing up (orthostatic hypotension), slower heartbeat rate (bradycardia), changes in blood sugar levels (important for diabetics), weight gain and increased cholesterol levels.

Eligibility Criteria

Exclusion Criteria

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

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I have diabetes.

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I have severe liver problems.

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I have a heart condition that affects how my heart pumps blood.

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

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

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I have a slow heartbeat or a condition causing irregular heart rhythms.

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

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I cannot take carvedilol due to health reasons.

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I have severe depression with a BDI score over 13.

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I have been diagnosed with sleep apnea.

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I have chronic high blood pressure.

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I have a severe narrowing of my heart's aortic valve.

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I have atrial fibrillation.

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I have frequent chest pain due to heart problems.

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I have COPD.

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My kidney function is severely reduced.

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I have asthma or experience bronchospasm.

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I have not had a heart attack in the last 2 days.

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I have a type of heart block.

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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 3 months up to 34 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 3 months up to 34 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 3 months up to 34 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

123I-MIBG reuptake changes

Secondary study objectives

Adverse Events frequency

Heart rate variability changes

Other study objectives

Central insulin resistance changes

Color vision changes as measured by HRR Pseudochromatic Plates

Constipation score changes using a questionnaire based on modified ROME III diagnostic criteria

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Trial Design

1Treatment groups

Experimental Treatment

Group I: carvedilol therapyExperimental Treatment1 Intervention

The dosage of carvedilol will be gradually increased from the initial recommended starting dose of 3.125 mg twice/daily, the target dose will be 25mg twice daily (50 mg/day) and participants will take 50 mg/day carvedilol for 6 months.Subjects that cannot tolerate the 50 mg daily dose, will be offered to continue at the 25 mg daily dose.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carvedilol

FDA approved

0 / 20Eligibility criteria met