Carvedilol for Parkinson's Disease
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using beta-adrenergic antagonists (a type of medication that affects the heart and blood vessels).
Is carvedilol safe for use in humans?
Carvedilol has been studied for its safety in humans under various brand names like Coreg and Eucardic, primarily for heart-related conditions. It is generally considered safe, with known side effects including dizziness, fatigue, and low blood pressure, but specific safety data for its use in Parkinson's Disease is limited to animal studies.12345
How does the drug Carvedilol differ from other treatments for Parkinson's disease?
Carvedilol is unique because it is a beta-blocker, which is typically used for heart conditions, but it may help manage tremors in Parkinson's disease. Unlike traditional Parkinson's treatments like levodopa, which have limited effects on tremors, beta-blockers like Carvedilol could offer an alternative approach by targeting the adrenergic system.26789
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.
Research Team
Michele L Lima Gregorio, MD, FAAN
Principal Investigator
Cedars-Sinai Medical Center
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive carvedilol treatment and undergo MIBG scan, DAT scan, and NM-MRI every six months
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Carvedilol
Carvedilol is already approved in United States, European Union, Canada, Japan for the following indications:
- Hypertension
- Heart failure
- Left ventricular dysfunction following myocardial infarction
- Hypertension
- Heart failure
- Left ventricular dysfunction following myocardial infarction
- Hypertension
- Heart failure
- Left ventricular dysfunction following myocardial infarction
- Hypertension
- Heart failure
- Left ventricular dysfunction following myocardial infarction
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cedars-Sinai Medical Center
Lead Sponsor