Status:
ACTIVE_NOT_RECRUITING
Adrenergic Blockers for Cardiac Changes in Early Parkinson's Disease (Protocol 53136)
Lead Sponsor:
Michele Tagliati, MD
Conditions:
REM Sleep Behavior Disorder
Pre-motor Parkinson Disease
Eligibility:
All Genders
50-85 years
Phase:
PHASE2
Brief Summary
REM Behavior Sleep Disorder (RBD) is a sleep disorder causing people to 'act out' their dreams. A high percentage of individuals with idiopathic RBD (iRBD) are known to develop conditions affecting th...
Detailed Description
Idiopathic Parkinson's disease (PD) is a progressive neurodegenerative disorder of unknown etiology, characterized by bradykinesia (slowness of movements) associated with tremor at rest and/or muscle ...
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) or Diagnosis of hyposmia. Diagnosis of RBD will be, 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) with a score of at least 1 in subitems 6.1 to 6.4 of question 6.
- At least one of the following:
- Diagnosis of hyposmia. Diagnosis of hyposmia will be 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 III 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 \>30%, 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
- Comorbidities related to SNS hyperactivity
- Heart failure (LVEF \<45%)
- Recent myocardial revascularization (\<12 weeks)
- Chronic Hypertension (SBP\>140mmHg-DBP\>90mmHg)
- Atrial fibrillation
- Diabetes mellitus
- COPD
- Sleep Apnea
- Severely reduced kidney function (Glomerular Filtration Rate\<30ml/min)
- Contraindications to the use of carvedilol
- Asthma or bronchospasm
- Recent myocardial infarction (\<48 h)
- Ongoing unstable angina
- Cardiogenic shock or prolonged hypotension
- Second or Third-Degree AV block
- Significant valvular aortic stenosis
- Obstructive cardiomyopathy, or constrictive pericarditis
- Symptomatic Bradycardia (HR\<60) or Sick Sinus Syndrome
- Stroke within the past 1 month
- Severe Hepatic Dysfunction
- Allergy/hypersensitivity to iodine or study medication
Key Trial Info
Start Date :
April 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03775096
Start Date
April 4 2019
End Date
July 1 2026
Last Update
January 28 2025
Active Locations (1)
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1
Michele L Lima Gregorio
Los Angeles, California, United States, 90046