← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Changes in 123I-Ioflupane uptake - DATscan

Secondary outcome measures

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 outcome measures

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

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carvedilol

FDA approved

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor

499 Previous Clinical Trials

164,842 Total Patients Enrolled

2 Trials studying REM Sleep Behavior Disorder

30 Patients Enrolled for REM Sleep Behavior Disorder

Michele L Lima Gregorio, MD, FAANPrincipal InvestigatorCedars-Sinai Medical Center

Media Library

Carvedilol (Adrenergic Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT04218968 — Phase 2

REM Sleep Behavior Disorder Research Study Groups: carvedilol therapy

REM Sleep Behavior Disorder Clinical Trial 2023: Carvedilol Highlights & Side Effects. Trial Name: NCT04218968 — Phase 2

Carvedilol (Adrenergic Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04218968 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is eligible to sign up for this test group?

"The requirements for entry into this particular clinical trial are a diagnosis of rem sleep behavior disorder and an age between 18-85. Right now, the study has room for 15 more participants."

Answered by AI

What is the main illness that Carvedilol helps to cure?

"Carvedilol is most often given to patients with hypertension, but it can also be used as a treatment for heart failure, hypesthesia, and left ventricular dysfunction."

Answered by AI

Are middle-aged individuals eligible to participate in this experiment?

"This trial is meant for patients that are aged 18 to 85. If the patient does not fall in this age bracket, there are still 139 other trials available for those under 18 and 775 options for patients over 65."

Answered by AI

How many people have been asked to participate in this research project?

"As of August 23rd, 2022, this trial is no longer recruiting patients. This study was first posted on December 30th, 2019 and had its last update less than a year ago. There are 888 other trials for rem sleep behavior disorder that are admitting patients and 29 studies involving Carvedilol currently looking for participants."

Answered by AI

Are there any other notable instances where Carvedilol has been used in a medical trial?

"At this moment, 29 different clinical trials are investigating Carvedilol. Of these active studies, 7 have reached Phase 3 testing. Most of the research concerning Carvedilol is taking place in Orlando, Florida; however, there are 978 total locations running various stages of these trials."

Answered by AI

Are people currently being recruited for this trial?

"As of 8/23/2022, this study is not enrolling patients. It was first posted on December 30th, 2019. If you are interested in other medical trials, there are 29 Carvedilol studies and 888 RBD studies that are currently looking for participants."

Answered by AI

Does Carvedilol carry any health risks?

"Carvedilol is a Phase 2 medication, meaning that while there is some data supporting its safety, there is no evidence yet of the drug's efficacy. Therefore, it received a score of 2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cardiac Changes in Early Parkinson's Disease: A Follow up Study

Michele Tagliati, MD 2019. "Cardiac Changes in Early Parkinson's Disease: A Follow up Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04218968.

All > Mental Illness