NCT04386317Active, not recruitingPhase 2
Terazosin Effect on Cardiac Changes in Early Parkinson's Disease
The Effect of a1- Adrenergic Receptor Antagonist Therapy on Cardiac and Striatal Transporter Uptake in Pre-Motor and Symptomatic Parkinson's Disease
Source: ClinicalTrials.gov · Last updated 2 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 24 Apr 2020
- Start date
- 1 Nov 2020
- Primary completion date
- 10 Dec 2025
- Lead sponsor
- Cedars-Sinai Medical Center
- Diseases
- Parkinson disease
- NCT number
- NCT04386317
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 15
- From 1 Nov 2020 to the primary completion date, 10 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- Allergy/hypersenstivity to iodine or study medication
Lab values
- 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.
Other
- Secondary Parkinsonism, including tardive
Who the study is looking for
- 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
Age in the registry: 50 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Michele L Lima Gregorio Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.