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

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 2, 2026 (before its estimated July 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor Re-verified, no change to tracked fieldsv9
  2. Notable Primary and study completion dates: Aug 1, 2024 to Jul 1, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v8
  3. Notable Primary and study completion dates: May 1, 2023 to Aug 1, 2024
    • Eligibility criteria revised
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study site revised
    v7
  4. Notable Primary and study completion dates: May 2022 to May 1, 2023
    • Eligibility criteria revised
    • Study title expanded, about 2 words
    v6
  5. Notable Primary and study completion dates: May 2021 to May 2022v5
Show 3 earlier versionsHide 3 earlier versions
  1. Notable Primary and study completion dates: Dec 2019 to May 2021v4
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 1, 2019 to Apr 4, 2019
    v3
  3. Notable Start date: Feb 2019 to Apr 1, 2019
    • Secondary endpoints: details revised at 2 of 2 entries
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 movements, walking difficulties) and other symptoms associated with PD (i.e. abnormal smell, constipation, depression, color vision abnormalities), as measured by specific clinical scales and exams.
Trial Details
NCT Number NCT03775096
Lead Sponsor Michele Tagliati, MD
Conditions
(from sponsor)
REM Sleep Behavior Disorder, Pre-motor Parkinson Disease, Symptomatic Parkinson Disease
Related terms Nerve Degeneration, Parkinson Disease, Parkinson Disease, Secondary, Primary Dysautonomias, REM Sleep Behavior Disorder
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov