Carvedilol for Early Parkinson's Disease

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen ByMichele Tagliati, MD, FAAN

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Michele Tagliati, MD

No Placebo Group

Prior Safety Data

Approved in 4 jurisdictions

Trial Summary

What is the purpose of this trial?REM Behavior Sleep Disorder (RBD) is a sleep disorder causing people to 'act out' their dreams. A high percentage of individuals with idiopathic RBD (iRBD) are known to develop conditions affecting the neurons in the brain such as Parkinson's disease (PD). Based on the increased risk to develop PD, individuals with iRBD are currently considered ideal candidates for therapies that can possibly protects brain cells, due to the critical window of opportunity to intervene early before brain cell loss progresses significantly. Early changes of PD are associated with a number of symptoms including loss of smell, constipation, anxiety and depression. In addition, early heart and brain abnormalities can be visualized using specialized imaging techniques called 123I-MIBG myocardial scintigraphy (MIBG) and dopamine transporter (DAT) single photon emission computerized tomography (SPECT) respectively. The combined presence of certain symptoms and the use of these imaging techniques are considered early markers of PD in individuals with iRBD. In other conditions, like heart failure, MIBG abnormalities are reversed by drugs able to block excessive adrenergic stimulation, known as beta-blockers. In this study the investigators want to learn about the effect of treatment with the beta-blocker carvedilol on MIBG abnormalities found in iRBD patients at risk to develop PD. The investigators believe that reversing the MIBG abnormality might prelude to a slowing of the neurodegenerative process. This drug is approved by the U.S. Food and Drug Administration (FDA) for congestive heart failure, hypertension and left ventricular dysfunction after myocardial infarction. However, carvedilol is not approved by the FDA in patients with iRBD at risk for PD. The available doses for this drug oral formulations are 3.125mg, 6.25mg, 12.5mg and 25mg. Changes visualized with the MIBG imaging technique will be correlated to the presence and severity of neurological (i.e. tremors, stiffness, slow movements, walking difficulties) and other symptoms associated with PD (i.e. abnormal smell, constipation, depression, color vision abnormalities), as measured by specific clinical scales and exams.

Eligibility Criteria

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.

Exclusion Criteria

I have diabetes.

I have severe liver problems.

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

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

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

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

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

I cannot take carvedilol due to health reasons.

I have severe depression with a BDI score over 13.

I have been diagnosed with sleep apnea.

I have chronic high blood pressure.

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

I have atrial fibrillation.

I have frequent chest pain due to heart problems.

I have COPD.

My kidney function is severely reduced.

I have asthma or experience bronchospasm.

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

I have a type of heart block.

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

Participant Groups

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.

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.

Carvedilol is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸 Approved in United States as Coreg for: