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Beta-blocker

Carvedilol for Parkinson's Disease

Q: What is the conventional use for Carvedilol?

<p>Although it is most frequently used to manage <a href="https://www.withpower.com/clinical-trials/hypertension">hypertension</a>, carvedilol can also help patients struggling with <a href="https://www.withpower.com/clinical-trials/heart-failure">heart failure</a>, hypesthesia, and left ventricular dysfunction.</p>

Phase 2

Recruiting

Led By Michele Tagliati, MD, FAAN

Research Sponsored by Michele Tagliati, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 3 months up to 34 weeks

Awards & highlights

Study Summary

This trial will test whether the drug carvedilol can improve MIBG abnormalities in people with iRBD, who are at risk of developing Parkinson's disease.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Carvedilol may cause dizziness, fatigue, low blood pressure when standing up (orthostatic hypotension), slower heartbeat rate (bradycardia), changes in blood sugar levels (important for diabetics), weight gain and increased cholesterol levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 3 months up to 34 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 3 months up to 34 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 3 months up to 34 weeks for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

123I-MIBG reuptake changes

Secondary outcome measures

Adverse Events frequency

Heart rate variability changes

Other outcome measures

Central insulin resistance changes

Color vision changes as measured by HRR Pseudochromatic Plates

Constipation score changes using a questionnaire based on modified ROME III diagnostic criteria

+7 more

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carvedilol

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Michele Tagliati, MDLead Sponsor

Michele Tagliati, MD, FAANPrincipal Investigator - Cedars-Sinai Medical Center

Cedars-Sinai Medical Center

University Di Roma-La Sapienza (Medical School)

Mt Sinai School Of Medicine (Residency)

1 Previous Clinical Trials

15 Total Patients Enrolled

Frequently Asked Questions

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

Does this research involve elderly individuals?

"According to the age bracket that is eligible for this clinical trial, patients must be aged 25 or older, and no older than 85."

Answered by AI

Are there any available openings for this clinical research?

"Yes, this is an active trial that was first posted on 4/4/2019. The listing was last updated on 8/23/2022 and currently 15 patients are needed from 1 site."

Answered by AI

What is the conventional use for Carvedilol?

"Although it is most frequently used to manage hypertension, carvedilol can also help patients struggling with heart failure, hypesthesia, and left ventricular dysfunction."

Answered by AI

Does Carvedilol have any dangerous side effects?

"Carvedilol is classified as a Phase 2 drug, meaning that while there is some data suggesting it is safe, none of the clinical trials have yet shown that it is effective."

Answered by AI

Are there specific requirements for participants in this research project?

"This study needs 15 individuals who have a diagnosis of parkinson's disease and meet the following age, gender, and symptom criteria: Male or female of age between 25 and 85 years at time of enrollment., Diagnosis of idiopathic REM sleep behavior disorder (iRBD) or Diagnosis of hyposmia. Diagnosis of RBD will be, established either as 'definite RBD' according to the criteria proposed by the International Classification of Sleep Disorders (ICSD)-2 [AASM, 2005] or 'probable RBD' following a score of 6 or higher in the RBD questionnaire (RBDS"

Answered by AI

Is Carvedilol a common medication used in research?

"There are currently 29 ongoing studies investigating the efficacy of Carvedilol. Of those, 7 are in Phase 3 clinical trials. The many trial locations for this medication include 978 sites across the globe, with a large concentration based in Orlando, Florida."

Answered by AI