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Beta-blocker

Carvedilol for Parkinson's Disease

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 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

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
~0 spots leftby Aug 2024
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