Overview

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

Status:
Enrolling by invitation
Trial end date:
2022-12-30
Target enrollment:
Participant gender:
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 123. I-Metaiodobenzylguanidine (MIBG) scintigraphy. Primary procedures in this study are MIBG scan, DAT scan, Neuromelanin Magnetic Resonance Imaging (NM-MRI), and carvedilol titration. Subjects will return for research visits and imaging every six months,for three years. We hypothesize that the rate of decline in DAT scan123I-Ioflupane uptake will be slower in subjects who have received the adrenergic blocker carvedilol, resulting in a decreased clinical phenoconversion rate to parkinsonism. If this is true, it might create a considerable window of opportunity for treatment with adrenergic blockers - or similar compounds able to reduce Sympathetic Nervous System (SNS) hyperactivity - which may result in long-term benefits such as delaying the neurodegenerative process and the onset of neurological symptoms.
Phase:
Phase 2
Details
Lead Sponsor:
Cedars-Sinai Medical Center
Treatments:
Adrenergic Antagonists
Carvedilol