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Terazosin and Parkinson's Disease Extension Study

RECRUITINGPhase 2Sponsored by Cedars-Sinai Medical Center
Actively Recruiting
PhasePhase 2
SponsorCedars-Sinai Medical Center
Started2022-09-23
Est. completion2025-11-01
Eligibility
Age50 Years – 85 Years
Healthy vol.Accepted
Locations1 site

Summary

The purpose of this study is to investigate the long-term effects of treatment with the selective post-synaptic a1-adrenergic blocker terazosin on serial in a population of subjects with defined pre-motor Parkinson's disease (PD) risks and abnormal imaging exams. Imaging changes will be correlated to the presence and severity of motor and non-motor symptoms of PD, measured by validated clinical scales and cardiac autonomic function tests.

Eligibility

Age: 50 Years – 85 YearsHealthy volunteers accepted
Inclusion Criteria:

* Enrolled in the study "The Effect of alpha1- adrenergic receptor antagonist Therapy on Cardiac and Striatal Transporter Uptake in Pre-Motor and Symptomatic Parkinson's Disease" (STUDY #000540)
* Capacity to give informed consent

Exclusion Criteria:

* Secondary Parkinsonism, including tardive
* Concurrent dementia defined by a score lower than 22 on The Montreal Cognitive Assessment (MoCA)
* Concurrent severe depression defined by a Beck Depression Inventory-Fast Screen (BDI fast screen) score greater than 13
* Comorbidities related to sympathetic nervous system (SNS) hyperactivity
* Heart failure (LVEF \<45%)
* Recent myocardial revascularization (\<12 weeks)
* Hypertension (systolic blood pressure SBP\>150mmHg (millimeters of mercury) or diastolic blood pressure DBP\>100mmHg)
* Chronic Atrial fibrillation
* Concurrent Use of Beta-adrenergic antagonist
* Diabetes mellitus
* Chronic Obstructive Pulmonary Disease (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 terazosin
* Recent myocardial infarction (\<48 h)
* Ongoing angina pectoris
* Cardiogenic shock or prolonged hypotension
* Breast-feeding
* Current use of phosphodiesterase type 5 inhibitors: sildenafil (ViagraTM), tadalafil (CialisTM), or vardenafil (LevitraTM)
* History of priapism (persistent and painful erection)
* Neurogenic orthostatic hypotension defined as symptomatic decrease in BP \> 20mmHg systolic or \> 10mmHg diastolic and HR increase \< 20bpm on supine to sitting or standing.
* Blood pressure less than 110 mm Hg systolic at screening or baseline visit
* Use of investigational drugs within 30 days before screening
* For female participant, pregnancy, or plans for child-bearing during study period
* Allergy/hypersensitivity to iodine or study medication

Conditions5

Heart DiseaseParkinson's DiseasePre-motor Parkinson's DiseaseREM Sleep Behavior DisorderSymptomatic Parkinson Disease

Locations1 site

Cedars Sinai Medical Center
Los Angeles, California, 90048
Michele L Gregorio, PhD4243150021michele.gregorio@cshs.org

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