NCT04218968Active, not recruitingPhase 2
Cardiac Changes in Early Parkinson's Disease: A Follow up Study
The Effect of Adrenergic Blocker Therapy on Cardiac and Striatal Transporter Uptake in Pre-Motor and Symptomatic Parkinson's Disease: A Follow up Study
Source: ClinicalTrials.gov · Last updated 2 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 26 Dec 2019
- Start date
- 30 Dec 2019
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Cedars-Sinai Medical Center
- Diseases
- Parkinson disease
- NCT number
- NCT04218968
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 15
- From 30 Dec 2019 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent dementia defined by a score lower than 22 on the MoCA
- Concurrent severe depression defined by a BDI fast screen score greater than 13
Other illness
- Contraindications to the use of carvedilol
- Asthma or bronchospasm
- Recent myocardial infarction (\<48 h)
- Ongoing unstable angina
- Cardiogenic shock or prolonged hypotension
- Second or Third-Degree AV block
- Significant valvular aortic stenosis
- Obstructive cardiomyopathy, or constrictive pericarditis
- Resting Heart Rate (RHR)\< 45 Or Bradycardia (HR\<60) with at least one of the following symptoms; Lightheadedness, dizziness, 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
Lab values
- Comorbidities related to SNS hyperactivity
- Heart failure (LVEF \<45%)
- Recent myocardial revascularization (\<12 weeks)
- Hypertension (SBP\>150mmHg or DBP\>100mmHg)
- Chronic Atrial fibrillation
- Concurrent Use of Beta-adrenergic antagonist
- Diabetes mellitus
- COPD
- Untreated Sever Sleep Apnea; Apnea-Hypopnea Index (AHI) \> 30/h.
- Severely reduced kidney function (Glomerular Filtration Rate\<30ml/min)
Other
- Secondary Parkinsonism, including tardive
Who the study is looking for
- Enrolled in the study "The Effect of Adrenergic Blocker Therapy on Cardiac and Striatal Transporter Uptake in Pre-Motor and Symptomatic Parkinson's Disease" (Pro#00053136)
- Capacity to give informed consent
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Michele L Lima Gregorio Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.