Status:
RECRUITING
Terazosin Effect on Cardiac Changes in Early Parkinson's Disease
Lead Sponsor:
Cedars-Sinai Medical Center
Conditions:
REM Sleep Behavior Disorder
Pre-motor Parkinson's Disease
Eligibility:
All Genders
50-85 years
Phase:
PHASE2
Brief 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 auto...
Detailed Description
Based on the increased risk to develop PD, individuals with iRBD are currently considered ideal candidates for therapies that can possibly protects brain cells, due to the critical window of opportuni...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04386317
Start Date
November 1 2020
End Date
December 30 2025
Last Update
November 26 2024
Active Locations (1)
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1
Michele L Lima Gregorio
Los Angeles, California, United States, 90046