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

StatusActive, Not Recruiting
PhasePhase 2
Started2019-12-30
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 2, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2026-02-26
Enrolling by Invitation→Active, Not Recruiting Study Identification, Study Status v8
Trial statusEnrolling by Invitation→Active, Not Recruiting
Primary completion date2025-12-30→2026-06-30
Completion date2025-12-30→2026-06-30
Study titlerevised
Cardiac Changes in Early Parkinson's Disease: aA Follow Upup Study
2024-11-22
Study Identification, Study Status v7
Study titlerevised
Cardiac Changes in Early Parkinson's Disease: Aa Follow upUp Study
2023-10-16
Study Status, Outcome Measures v6
Re-verified, no change to tracked fields
2023-10-04
Study Status, Study Description, Arms and Interventions, Outcome Measures, Contacts/Locations v5
Secondary endpoints4 entries, revised
Changes in 123I-MIBG reuptake, as measured by late H/M ratio, between baseline and every six months for three years Changes in 123I-MIBG reuptake, as measured by WR reduction, between baseline and every six months for three yearsrate
Primary endpoints1 entry, revised
Changes in 123I-Ioflupane uptake, as- measured by specific binding ratio (SBR), between baseline, year one, year two and year three.DATscan
Study description+773 characters
Primary procedures in this study are MIBG scan, DAT scan, Neuromelanin Magnetic Resonance Imaging (NM-MRI), and carvedilol treatment. Subjects will return for research visits and imaging tests every six months for three years. We hypothesize that the rate of decline in DAT scan123I-Ioflupane uptake [...]
Study sites1 entry, revised
CedarsMichele SinaiL MedicalLima CenterGregorio
2022-08-23
Study Status, Sponsor/Collaborators v4
Primary completion date2022-12-30→2025-12-30
Completion date2022-12-30→2025-12-30
Show 3 earlier versions
2021-07-26
2 amendments v2-v3
2 re-verifications since 2021-05-25, no change to tracked fields
2020-01-03
Study Status, Eligibility v1
Eligibility criteria+5 characters
[...] ziness, weakness, Altered mental status, Shortness of breath, Pre-Syncope, Syncope, Sick Sinus Syndrome, Stroke within the past 1 month, Severe Hepatic Dysfunction Allergy/hypersensitivity to iodine or study medication
2020-01-02
Original filing
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.
Trial Details
NCT Number NCT04218968
Lead Sponsor Cedars-Sinai Medical Center
Conditions REM Sleep Behavior Disorder, Pre-motor Parkinson Disease, Symptomatic Parkinson Disease
Enrollment 15 participants
Start Date 2019-12-30
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-02