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Terazosin Effect on Cardiac Changes in Early Parkinson's Disease

StatusActive, Not Recruiting
PhasePhase 2
Started2020-11-01
View on ClinicalTrials.gov ↗

Amendment history

2026-02-26
Recruiting→Active, Not Recruiting Study Identification, Study Status, Contacts/Locations v6
Trial statusRecruiting→Active, Not Recruiting
Primary completion dateestimated 2025-12-30→confirmed 2025-12-10
Completion date2025-12-30→2026-03-10
Study sitesdetails revised at 1 of 1 site
2024-11-22
Study Identification, Study Status, Contacts/Locations v5
Study sitescontacts updated at 1 of 1 site
2023-10-04
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v4
Eligibility criteriarevised
Inclusion Criteria: Male or female of age between 2550 and 85 years at time of enrollment. Diagnosis of idiopathic [...]
Secondary endpointsdetails revised at 3 of 3 entries
Study description+1,725 characters
Based on the increased risk to develop PD, individuals with iRBD are currently considered ideal candidates for therapies that can possibly protects brain cells, due to the critical window of opportunity to intervene early before brain cell loss progresses significantly. Early changes of PD are assoc [...]
Study sites1 entry, revised
CedarsMichele SinaiL MedicalLima CenterGregorio
2022-08-23
Study Status, Sponsor/Collaborators v3
Primary completion date2022-03-20→2025-12-30
Completion date2023-03-20→2025-12-30
2021-10-13
Study Status, Contacts/Locations v2
Re-verified, no change to tracked fields
2020-11-02
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2020-07-01→confirmed 2020-11-01
Study sites0→1
2020-05-08
Original filing
Parkinson's disease (PD) is characterized by many non-motor symptoms that occur several years before the diagnosis, in particular idiopathic REM behavior disorder (iRBD), which is associated with autonomic impairment. The purpose of this study is to investigate the effect of treatment with the selective post-synaptic a1-adrenergic blocker terazosin on 123I-MIBG myocardial uptake in a population of subjects with defined pre-motor PD risks (i.e. hyposmia and RBD) and abnormal baseline 123I-MIBG uptake, with or without 123I-Ioflupane uptake abnormality or PD motor symptoms. Scintigraphic changes will be correlated to motor and non-motor severity of PD, measured by validated clinical scales and cardiac autonomic function tests.
Trial Details
NCT Number NCT04386317
Lead Sponsor Cedars-Sinai Medical Center
Conditions REM Sleep Behavior Disorder, Pre-motor Parkinson's Disease, Symptomatic Parkinson Disease
Enrollment 15 participants
Start Date 2020-11-01
Primary Completion 2025-12-10 (estimated)
Study Completion 2026-03-10 (estimated)
Updated on ClinicalTrials.gov 2026-03-02