Cardiac Changes in Early Parkinson's Disease: a Follow Up Study

Launched by CEDARS-SINAI MEDICAL CENTER · Jan 2, 2020

Keywords

ClinConnect Summary

This study is exploring whether carvedilol, a heart medicine, might slow certain brain changes and delay the development of Parkinson-like symptoms in people who are at higher risk but do not yet have Parkinson’s disease. It’s a small, single-group trial (all participants receive carvedilol) that plans to follow about 15 adults for three years, with yearly brain scans to track changes in the dopamine system. The researchers are looking to see if carvedilol can slow the brain changes seen on the DAT scan and possibly reduce how quickly people convert to Parkinson’s or related conditions.

Who can join? Adults aged 18 to 85 who have REM sleep behavior disorder plus at least one other risk factor such as reduced sense of smell, constipation, depression, or color-vision problems, and an abnormal heart imaging test (MIBG). You must be able to consent and not have certain conditions (for example, secondary Parkinsonism or dementia) or health issues that would make carvedilol unsafe. The study is based at Cedars-Sinai Medical Center in Los Angeles and involves visits and brain imaging every six months for three years, along with questionnaires and tests about sleep, smell, vision, movement, and heart function. Participants start with a low carvedilol dose (12.5 mg) twice daily and may increase to 25 mg twice daily if tolerated. Note that results are not yet available, and the study is still enrolling by invitation with safety oversight in place.

Gender

ALL

Eligibility criteria

• 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
• • Allergy/hypersensitivity to iodine or study medication