Carvedilol for Parkinson's Disease

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byMichele L Lima Gregorio, MD, FAAN

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Cedars-Sinai Medical Center

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?The purpose of this study is to investigate the long-term effects of treatment with the adrenergic blocker carvedilol on serial DaTscan, a dopamine transporter (DAT) single photon emission computerized tomography (SPECT) imaging technique in a population of subjects with defined pre-motor Parkinson's disease risks (i.e., REM sleep Behavior Disorder (RBD) and at least one among hyposmia, constipation, depression and color vision abnormality) and abnormal 123I-Metaiodobenzylguanidine (MIBG) scintigraphy.

Eligibility Criteria

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.

Inclusion Criteria

Enrolled in the study "The Effect of Adrenergic Blocker Therapy on Cardiac and Striatal Transporter Uptake in Pre-Motor and Symptomatic Parkinson's Disease" (Pro#00053136)

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

Exclusion Criteria

I have asthma or experience bronchospasm.

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

I am currently taking beta-blocker medication.

+20 more

Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: carvedilol therapyExperimental Treatment1 Intervention

Twice daily oral doses of adrenergic blocker 12.5 mg or 25mg, according to patient tolerability.

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

🇺🇸 Approved in United States as Coreg for: