Carvedilol for REM Sleep Behavior Disorder

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
REM Sleep Behavior Disorder+5 More
Carvedilol - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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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.

Eligible Conditions
  • REM Sleep Behavior Disorder
  • Pre-motor Parkinson's Disease
  • Symptomatic Parkinson Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 3 years

3 years
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)
Diagnosis of PD or other synucleinopathies by the end of 3 years in the study population
Differences in integrity of pigmented neurons in the locus coeruleus and substantia nigra between baseline, year one, year two and year three
Sensitivity and specificity of DAT Scan compared to MIBG in predicting RBD conversion to PD/other synucleinopathies
Year 3
Central and peripheral insulin resistance changes between baseline and every 6 months for three years
Changes in 123I-MIBG reuptake, as measured by WR reduction, between baseline and every six months for three years
Changes in 123I-MIBG reuptake, as measured by late H/M ratio, between baseline and every six months for three years
Color vision changes, as assessed using HRR Pseudoisochromatic Plates, between baseline and every 6 months for three years
Functional constipation score changes between baseline and every 6 months for three years
Heart Rate Variability (HRV) changes between baseline and every 6 months for three years
MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III changes from OFF medication between baseline and every 6 months for three years
Non-Motor Symptoms Scale (NMSS) changes between baseline and every 6 months for three years
REM sleep Behavior Disorder Screening questionnaire (RBDSQ) changes between baseline and every 6 months for three years
Scales for Outcomes in Parkinson's Disease - Autonomic Dysfunction (SCOPA-AUT) changes between baseline and every 6 months for three years
University of Pennsylvania Smell Identification Test (UPSIT) changes between baseline and every 6 months for three years
Every year for three years
Changes in 123I-Ioflupane uptake, as measured by specific binding ratio (SBR), between baseline, year one, year two and year three.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

carvedilol therapy
1 of 1

Experimental Treatment

15 Total Participants · 1 Treatment Group

Primary Treatment: Carvedilol · No Placebo Group · Phase 2

carvedilol therapy
Drug
Experimental Group · 1 Intervention: Carvedilol · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Carvedilol
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 3 years

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor
452 Previous Clinical Trials
144,157 Total Patients Enrolled
2 Trials studying REM Sleep Behavior Disorder
30 Patients Enrolled for REM Sleep Behavior Disorder

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
This study will investigate how adrenergic blocker therapy affects cardiac and striatal transporter uptake in people with pre-motor and symptomatic Parkinson's disease.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 24th, 2021

Last Reviewed: November 18th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.