Adrenergic Blockers for Cardiac Changes in Early Parkinson's Disease (Protocol 53136)

• Register: ClinicalTrials.gov
• Last refreshed on: 22 January 2024
• Main ID: NCT03775096
• Date of registration: 09/12/2018
• Prospective Registration: Yes
• Primary sponsor: Michele Tagliati, MD
• Public title: Adrenergic Blockers for Cardiac Changes in Early Parkinson's Disease (Protocol 53136)
• Scientific title: The Effect of Adrenergic Blocker Therapy on Cardiac and Striatal Transporter Uptake in Pre-Motor and Symptomatic Parkinson's Disease
• Date of first enrolment: April 4, 2019
• Target sample size: 15
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03775096
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Michele Tagliati, MD, FAAN
• Affiliation: Cedars-Sinai Medical Center

• Name: Michele L Lima Gregorio, PhD

• Name: Michele L Gregorio, PhD

Key inclusion & exclusion criteria

Inclusion Criteria:

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:

1. 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.

2. Functional constipation, assessed by a scores > 4 on a questionnaire based on modified
ROME III 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 >30%, 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

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



Age minimum: 50 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pre-motor Parkinson Disease

Symptomatic Parkinson Disease

REM Sleep Behavior Disorder

Intervention(s)

Drug: Carvedilol

Primary Outcome(s)

123I-MIBG reuptake changes [Time Frame: At baseline and at 26 weeks of treatment.]

Secondary Outcome(s)

Heart rate variability changes [Time Frame: At baseline and at 26 weeks of treatment.]

Adverse Events frequency [Time Frame: every 3 months up to 34 weeks]

Secondary ID(s)

U1111-1223-7784

Source(s) of Monetary Support

Please refer to primary and secondary sponsors