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Could a common heart pill delay Parkinson's? small study hints at possibility

NCT ID NCT03775096

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · 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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2019

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

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

50 to 85 years

Sex

Anyone

Healthy volunteers

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

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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