Terazosin Effect on Cardiac Changes in Early Parkinson's Disease

Running, not enrolling · Phase 2

Conditions studied: REM Sleep Behavior Disorder, Pre-motor Parkinson's Disease, Symptomatic Parkinson Disease

In brief

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.

Key facts

Study ID: NCT04386317
Run by: Cedars-Sinai Medical Center
People needed: 15
Starts: 2020-11-01
Expected to finish: 2026-03-10
Last updated by the study team: 2026-03-02

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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:
Diagnosis of hyposmia, established as a University of Pennsylvania Smell Identification Test (UPSIT) score < 20th percentile for the individual's age group and sex.
Functional constipation assessed by a scores > 4 on a questionnaire based on modified ROME IV diagnostic criteria.
Color vision abnormality, as assessed using HRR Pseudoisochromatic Plates, in the absence of congenital dyschromatopsia
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

You may not qualify if…

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

Where it is running

Michele L Lima Gregorio — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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