Active — Not RecruitingPhase 2

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

United States15 participantsStarted 2019-12-30

Plain-language 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.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * Secondary Parkinsonism, including tardive * 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 * 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) * 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 * Al…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in 123I-Ioflupane uptake - DATscan

Timeframe: Every year for three years

Trial details

NCT IDNCT04218968

SponsorCedars-Sinai Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

View on ClinicalTrials.gov More REM Sleep Behavior Disorder trials