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NCT04218968 · ClinicalTrials.gov registry record · Phase 2

Cardiac Changes in Early Parkinson's Disease: A Follow up Study

A Phase 2 study of REM Sleep Behavior Disorder and Symptomatic Parkinson Disease, sponsored by Cedars-Sinai Medical Center.

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

NCT04218968: Active Phase 2 study of REM Sleep Behavior Disorder and Symptomatic Parkinson Disease, sponsored by Cedars-Sinai Medical Center.

NCT04218968 is a Phase 2 study of REM Sleep Behavior Disorder and Symptomatic Parkinson Disease that is active but no longer recruiting, run by Cedars-Sinai Medical Center. 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. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04218968, a Phase 2 study of REM Sleep Behavior Disorder and Symptomatic Parkinson Disease, is active but no longer recruiting, sponsored by Cedars-Sinai Medical Center.

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

Study Summary

The purpose of this study is to investigate the long-term effects of treatment with the adrenergic blocker carvedilol on serial DaTscan, a dopamine transporter (DAT) single photon emission computerized tomography (SPECT) imaging technique in a population of subjects with defined pre-motor Parkinson's disease risks (i.e., REM sleep Behavior Disorder (RBD) and at least one among hyposmia, constipation, depression and color vision abnormality) and abnormal 123I-Metaiodobenzylguanidine (MIBG) scintigraphy.

Primary Outcome

Changes in 123I-Ioflupane uptake, as measured by specific binding ratio (SBR), between baseline, year one, year two and year three.

Interventions

  • DRUG Carvedilol

Study Locations (1)

California

  • Michele L Lima Gregorio - Los Angeles

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2019-12-30
Est. Completion 2026-06-30
Phase Phase 2
Cedars-Sinai Medical Center

339 total trials

What the registry record for NCT04218968 still lists

NCT04218968 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 156-participant average among 11 other REM Sleep Behavior Disorder trials with a reported enrollment target (90% lower).

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.

NCT04218968 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT04218968 about?

NCT04218968 is a clinical study titled "Cardiac Changes in Early Parkinson's Disease: A Follow up Study". The purpose of this study is to investigate the long-term effects of treatment with the adrenergic blocker carvedilol on serial DaTscan, a dopamine transporter (DAT) single photon emission computerized tomography (SPECT) imaging technique in a population of subjects with defined pre-motor Parkinson'...

What is the current status of trial NCT04218968?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2019-12-30. Estimated completion is 2026-06-30.

What conditions does trial NCT04218968 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 NCT04218968?

The interventions under investigation include: Carvedilol (DRUG).

Who is sponsoring clinical trial NCT04218968?

This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04218968 being conducted?

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

Similar trials for REM Sleep Behavior Disorder

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04218968's enrollment target sits among peer trials

15 9th of 11 the lowest of 11 other REM Sleep Behavior Disorder trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other REM Sleep Behavior Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04218968, the US trial registry maintained by the National Library of Medicine. NCT04218968 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.