Carvedilol for Parkinson's Disease

Enrolling by invitation at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Cedars-Sinai Medical Center

Must not be taking: Beta-blockers

Disqualifiers: Dementia, Severe depression, Heart failure, Hypertension, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 3 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the drug carvedilol to determine its effectiveness for early signs of Parkinson's disease. Researchers aim to discover if carvedilol can improve brain scans related to dopamine, a brain chemical affecting movement and mood, in individuals with early symptoms like sleep issues, loss of smell, or constipation. Eligible participants should exhibit early signs of Parkinson's, such as REM sleep disorder and other symptoms like loss of smell or mood changes, but must not have conditions like asthma or uncontrolled high blood pressure. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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 there any evidence suggesting that carvedilol is likely to be safe for humans?

Research has shown that carvedilol is generally safe. Common side effects include dizziness, fatigue, and low blood pressure, which many people experience while taking this medication. Specific safety information for using carvedilol in Parkinson's disease is not available. However, its approval for other conditions suggests it is usually well-tolerated. Always consult a healthcare provider to understand the risks and benefits for your situation. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Parkinson's?

Unlike the standard treatments for Parkinson's disease, which primarily focus on replenishing dopamine or managing symptoms with drugs like levodopa or dopamine agonists, carvedilol offers a novel approach. Carvedilol is a beta-adrenergic blocker, a different class of medication, which might help mitigate some Parkinson's symptoms by targeting the adrenergic system. Researchers are excited because this could mean a new way to manage Parkinson's symptoms, potentially offering benefits for patients who don't respond well to existing therapies.

What evidence suggests that carvedilol might be an effective treatment for Parkinson's disease?

Studies have shown that carvedilol, the treatment under investigation in this trial, might aid Parkinson’s disease by blocking certain stress-related signals in the body, potentially affecting brain chemicals like dopamine. Although direct evidence for its effectiveness in Parkinson's is limited, research suggests that carvedilol can reduce stress responses, which might help manage symptoms. Individuals taking carvedilol for other health issues have reported improved heart function, suggesting possible benefits for related systems. However, strong evidence is lacking that blood pressure medications like carvedilol can prevent or alter the course of Parkinson's disease. More research is needed to understand how carvedilol might help treat Parkinson's. ^{2 3 5 6 7}

Who Is on the Research Team?

Michele L Lima Gregorio, MD, FAAN

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive carvedilol treatment and undergo MIBG scan, DAT scan, and NM-MRI every six months

3 years

Every 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Carvedilol

Trial Overview 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.

How Is the Trial Designed?

Group I: carvedilol therapy Experimental Treatment 1 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:

• Hypertension
• Heart failure
• Left ventricular dysfunction following myocardial infarction

Approved in European Union as Dilatrend for:

• Hypertension
• Heart failure
• Left ventricular dysfunction following myocardial infarction

Approved in Canada as Eucardic for:

• Hypertension
• Heart failure
• Left ventricular dysfunction following myocardial infarction

Approved in Japan as Carloc for:

• Hypertension
• Heart failure
• Left ventricular dysfunction following myocardial infarction

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Published Research Related to This Trial

In a long-term study involving 419 participants with early and advanced Parkinson's disease, ropinirole extended release was found to be safe, with no new or unexpected safety concerns over a median exposure of 1275 days.

Most participants (87%) experienced at least one adverse event, with common issues including back pain and hallucinations, but a majority preferred the once-daily dosing regimen over more frequent dosing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term, open-label, safety study of once-daily ropinirole extended/prolonged release in early and advanced Parkinson's disease. Makumi, CW., Asgharian, A., Ellis, J., et al.[2016]

Citations

1. withpower.com withpower.com/trial/phase-3-parkinson-disease-11-2019-f9c08

Carvedilol for Parkinson's Disease · Info for Participants The purpose of this study is to investigate the long-term effects of treatment with the adrenergic blocker carvedilol on serial DaTscan, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12295565/

Anti‐hypertensive drugs as disease‐modifying agents for ... There is currently a lack of evidence for the use of antihypertensive drugs for either the primary or secondary prevention of PD. More observational studies are ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10852762/

The Role of β-Adrenergic Blockers in Parkinson's Disease Carvedilol significantly reduced ischemia–reperfusion-induced poly- and mono-adenosine diphosphate-ribosylation in heart perfusion and rheological models.

4. link.springer.com link.springer.com/article/10.1007/s40801-015-0008-7

Safety of Pharmacotherapy for Arterial Hypertension | Drugs In this study, we review interactions between therapies used in PD and selected antihypertensive agents.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT00323037

A Study to Compare the Effects of Coreg CR and Coreg IR ... The purpose of this study is to determine if Coreg CR is as effective as Coreg IR in improving heart function in subjects with stable chronic heart failure.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11979683/

Association Between β‐Adrenoreceptor Agonists and ... Overall, ever users of β‐antagonists had a 41% increased risk of PD compared to never users of β‐antagonists. The summary effect estimates for ...

7. movementdisorders.onlinelibrary.wiley.com movementdisorders.onlinelibrary.wiley.com/doi/10.1002/mds.108

β2‐adrenoceptor agonists and antagonists and risk of ... Results: During follow-up 11,314 patients were newly diagnosed with PD and were matched with 113,140 controls. An increased risk of PD was seen ...