Terazosin and Parkinson's Disease Extension Study

• Status: Not yet recruiting
• Trial end date: 2025-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cedars-Sinai Medical Center
• Treatments: Terazosin

Criteria

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 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 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