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Could a common heart pill delay Parkinson's? small study hints at possibility
NCT ID NCT03775096
First seen Jun 27, 2026 ยท Last updated Jun 27, 2026
Summary
This study looks at whether carvedilol, a drug used for heart failure, can reverse early heart changes seen in people with a sleep disorder that puts them at high risk for Parkinson's disease. Fifteen participants with REM sleep behavior disorder or reduced sense of smell will take carvedilol for a year. The goal is to see if the drug improves heart imaging results and possibly slows down brain changes linked to Parkinson's.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2019
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Michele L Lima Gregorio
Los Angeles, California, 90046, United States
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Other studies related to the condition(s) this trial covers.
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