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NCT03775096 · ClinicalTrials.gov registry record · Phase 2

Adrenergic Blockers for Cardiac Changes in Early Parkinson's Disease (Protocol 53136)

A Phase 2 study of REM Sleep Behavior Disorder and Symptomatic Parkinson Disease, sponsored by Michele Tagliati, MD.

Active
Registry status
Phase 2
Development phase
15
Enrollment target
1
Study location

NCT03775096 is a Phase 2 study of REM Sleep Behavior Disorder and Symptomatic Parkinson Disease that is active but no longer recruiting, run by Michele Tagliati, MD. The registered enrollment target is 15 participants, below the 156-participant average among 11 other REM Sleep Behavior Disorder trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03775096, a Phase 2 study of REM Sleep Behavior Disorder and Symptomatic Parkinson Disease, is active but no longer recruiting, sponsored by Michele Tagliati, MD.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
15 participants
Enrollment target
1
Study location

Study Summary

REM Behavior Sleep Disorder (RBD) is a sleep disorder causing people to 'act out' their dreams. A high percentage of individuals with idiopathic RBD (iRBD) are known to develop conditions affecting the neurons in the brain such as Parkinson's disease (PD). Based on the increased risk to develop PD, individuals with iRBD are currently considered ideal candidates for therapies that can possibly protects brain cells, due to the critical window of opportunity to intervene early before brain cell loss progresses significantly. Early changes of PD are associated with a number of symptoms including loss of smell, constipation, anxiety and depression. In addition, early heart and brain abnormalities can be visualized using specialized imaging techniques called 123I-MIBG myocardial scintigraphy (MIBG) and dopamine transporter (DAT) single photon emission computerized tomography (SPECT) respectively. The combined presence of certain symptoms and the use of these imaging techniques are considered early markers of PD in individuals with iRBD. In other conditions, like heart failure, MIBG abnormalities are reversed by drugs able to block excessive adrenergic stimulation, known as beta-blockers. In this study the investigators want to learn about the effect of treatment with the beta-blocker carvedilol on MIBG abnormalities found in iRBD patients at risk to develop PD. The investigators believe that reversing the MIBG abnormality might prelude to a slowing of the neurodegenerative process. This drug is approved by the U.S. Food and Drug Administration (FDA) for congestive heart failure, hypertension and left ventricular dysfunction after myocardial infarction. However, carvedilol is not approved by the FDA in patients with iRBD at risk for PD. The available doses for this drug oral formulations are 3.125mg, 6.25mg, 12.5mg and 25mg. Changes visualized with the MIBG imaging technique will be correlated to the presence and severity of neurological (i.e. tremors, stiffness, slow m

Conditions Studied

REM Sleep Behavior Disorder Symptomatic Parkinson Disease Pre-motor Parkinson Disease

Interventions

  • DRUG Carvedilol

Study Locations (1)

California

  • Michele L Lima Gregorio - Los Angeles

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2019-04-04
Est. Completion 2026-07-01
Phase Phase 2

Sponsor

Michele Tagliati, MD

1 total trials

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What the Registry Record Tells You About NCT03775096

The ClinicalTrials.gov registry entry for NCT03775096 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 156-participant average among 11 other REM Sleep Behavior Disorder trials with a reported enrollment target (90% lower). The listed sponsor is Michele Tagliati, MD, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with REM Sleep Behavior Disorder appearing as the primary indexed condition, and to 1 intervention - of which Carvedilol is the first listed.

NCT03775096 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT03775096 about?

NCT03775096 is a clinical study titled "Adrenergic Blockers for Cardiac Changes in Early Parkinson's Disease (Protocol 53136)". REM Behavior Sleep Disorder (RBD) is a sleep disorder causing people to 'act out' their dreams. A high percentage of individuals with idiopathic RBD (iRBD) are known to develop conditions affecting the neurons in the brain such as Parkinson's disease (PD). Based on the increased risk to develop PD, ...

What is the current status of trial NCT03775096?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2019-04-04. Estimated completion is 2026-07-01.

What conditions does trial NCT03775096 study?

This clinical trial studies the following conditions: REM Sleep Behavior Disorder, Symptomatic Parkinson Disease, Pre-motor Parkinson Disease.

What interventions are being tested in trial NCT03775096?

The interventions under investigation include: Carvedilol (DRUG).

Who is sponsoring clinical trial NCT03775096?

This trial is sponsored by Michele Tagliati, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03775096 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.