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ACTIVE NOT RECRUITING

NCT04386317

PHASE2

Terazosin Effect on Cardiac Changes in Early Parkinson's Disease

Sponsor: Cedars-Sinai Medical Center

View on ClinicalTrials.gov

Summary

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.

Official title: The Effect of a1- Adrenergic Receptor Antagonist Therapy on Cardiac and Striatal Transporter Uptake in Pre-Motor and Symptomatic Parkinson's Disease

Key Details

Gender

All

Age Range

50 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2020-11-01

Completion Date

2026-03-10

Last Updated

2026-03-02

Healthy Volunteers

Conditions

REM Sleep Behavior Disorder Pre-motor Parkinson's Disease Symptomatic Parkinson Disease

Interventions

DRUG

Terazosin

Fifteen patients with defined pre-motor PD risk and abnormal baseline 123I-MIBG uptake, with or without 123I-Ioflupane uptake abnormality or PD motor symptoms, will be recruited to receive daily oral doses of terazosin 5 mg or 10 mg. The dosage of terazosin will be gradually increased from the initial recommended starting dose of 1 mg daily at bedtime and titrated stepwise to 2mg, 5mg or 10 mg weekly, according to patient tolerability, as measured by subjective complaints, arterial blood pressure and heart rate. The target dose will be 5 mg or 10 mg daily based on subject's tolerability. Development of incompatibility will be addressed by individually adjusting the dose of terazosin.

Inclusion Criteria: * Male or female of age between 50 and 85 years at time of enrollment. * Diagnosis of idiopathic REM sleep behavior disorder (iRBD), established either as 'definite RBD' according to the criteria proposed by the International Classification of Sleep Disorders (ICSD)-2 \[AASM, 2005\] or 'probable RBD' following a score of 6 or higher in the RBD questionnaire (RBDSQ) \[Nomura et al, 2011\], with a score of at least 1 in subitems 6.1 to 6.4 of question 6 \[Halsband et al, 2018\]. * At least one of the following: 1. Diagnosis of hyposmia, established as a University of Pennsylvania Smell Identification Test (UPSIT) score \< 20th percentile for the individual's age group and sex. 2. Functional constipation assessed by a scores \> 4 on a questionnaire based on modified ROME IV diagnostic criteria. 3. Color vision abnormality, as assessed using HRR Pseudoisochromatic Plates, in the absence of congenital dyschromatopsia 4. Symptoms of depression, as assessed by a Beck Depression Inventory (BDI) fast screen score \>3 or concurrent use of antidepressant medications. * Abnormal 123I-MIBG myocardial scintigraphy, as defined by a Late H/M ratio \< 2.2 and/or a WR \>20%, with normal cardiac ejection fraction (LVEF \>55%). * 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 * Comorbidites related to SNS hyperactivity * Heart failure (LVEF\< 45%) * Recent myocardial revascularization (\< 12 weeks) * Hypertension (SBP \>150 mmHg or DBP\> 100mmHg) * Chronic Atrial fibrillation * Concurrent use of Alpha- adrenergic antagonist * Diabetes mellitus * COPD * Untreated Severe Sleep Apnea; Apnea-Hypopnea Index (AHI) \> 30/h. * Contraindication to the use of Terazosin * Recent myocardial infarction (\< 48 h) * Ongoing angina pectoris * Cardiogenic shock or prolonged * Breast feeding * Current use of Phosphodiesterase type 5 inhibitors: sildenafil (Viagra TM), tadalafil (Cialis TM), or vardenafil (Levitra TM) * History of Priapism * Neurogenic orthostatic hypotensiondefiened as symptomatic decrease in BP\> 20 mmHg systolic or \> 10mmHg diastolic and HR increase \< 20bpm on supine to sitting or standing * Blood pressure less than 110 mmHG systolic at screening or baseline visit * Use of investigational drugs whitin 30 days before screening * For female participant, Pregnacy, or plans for child-bearing during study period * Allergy/hypersenstivity to iodine or study medication

Locations (1)

Michele L Lima Gregorio

Los Angeles, California, United States