REM Sleep Behavior DisorderPhase 2NCT04218968
Cardiac Changes in Early Parkinson's Disease: A Follow up Study
A Phase 2 study testing Carvedilol in people with REM Sleep Behavior Disorder and Pre-motor Parkinson Disease, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to investigate the long-term effects of treatment with the adrenergic blocker carvedilol on serial DaTscan, a dopamine transporter (DAT) single photon emission computerized tomography (SPECT) imaging technique in a population of subjects with defined pre-motor Parkinson's disease risks… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- REM Sleep Behavior Disorder, Pre-motor Parkinson Disease, Symptomatic Parkinson Disease
- What is being tested?
- Carvedilol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2019to 30 Jun 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrolled in the study "The Effect of Adrenergic Blocker Therapy on Cardiac and Striatal Transporter Uptake in Pre-Motor and Symptomatic Parkinson's Disease" (Pro#00053136)
- Capacity to give informed consent
Who cannot join
- 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)
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- Hypertension (SBP>150mmHg or DBP>100mmHg)
- Chronic Atrial fibrillation
- Concurrent Use of Beta-adrenergic antagonist
- Diabetes mellitus
- COPD
- Untreated Sever Sleep Apnea; Apnea-Hypopnea Index (AHI) > 30/h.
- 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
- Resting Heart Rate (RHR)< 45 Or Bradycardia (HR<60) with at least one of the following symptoms; Lightheadedness, dizziness, weakness, Altered mental status, Shortness of breath, Pre-Syncope, Syncope, Sick Sinus Syndrome, Stroke within the past 1 month, Severe Hepatic Dysfunction
- Allergy/hypersensitivity to iodine or study medication
Trial locations and contacts
1 site in 1 country.
United States1 site
Michele L Lima Gregorio
Los Angeles, California, 90046
About this study
Official title: The Effect of Adrenergic Blocker Therapy on Cardiac and Striatal Transporter Uptake in Pre-Motor and Symptomatic Parkinson's Disease: A Follow up Study
The purpose of this study is to investigate the long-term effects of treatment with the adrenergic blocker carvedilol on serial DaTscan, a dopamine transporter (DAT) single photon emission computerized tomography (SPECT) imaging technique in a population of subjects with defined pre-motor Parkinson's disease risks (i.e., REM sleep Behavior Disorder (RBD) and at least one among hyposmia, constipation, depression and color vision abnormality) and abnormal 123I-Metaiodobenzylguanidine (MIBG) scintigraphy.
Read the detailed description
Primary procedures in this study are MIBG scan, DAT scan, Neuromelanin Magnetic Resonance Imaging (NM-MRI), and carvedilol treatment. Subjects will return for research visits and imaging tests every six months for three years. We hypothesize that the rate of decline in DAT scan123I-Ioflupane uptake will be slower in subjects who have received the adrenergic blocker carvedilol, resulting in a decreased clinical phenoconversion rate to parkinsonism. If this is true, it might create a considerable window of opportunity for treatment with adrenergic blockers - or similar compounds able to reduce Sympathetic Nervous System (SNS) hyperactivity - which may result in long-term benefits such as delaying the neurodegenerative process and the onset of neurological symptoms.
- Being tested
- Carvedilol
- Medical subject headings
- REM Sleep Behavior Disorder, Parkinson Disease, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarvedilolDrug
Primary procedures in this study are MIBG scan, DAT scan, NM-MRI, and carvedilol titration. Subjects will return for research visits and imaging every six months for three years. The investigators hypothesize that the rate of decline in DAT scan123I-Ioflupane uptake will be slower in subjects who have received the adrenergic blocker carvedilol, resulting in a decreased clinical phenoconversion rate to parkinsonism.
| Study group | Role | What they receive |
|---|---|---|
| carvedilol therapy | Experimental | Twice daily oral doses of adrenergic blocker 12.5 mg or 25mg, according to patient tolerability. Receives: Drug: Carvedilol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in 123I-Ioflupane uptake - DATscan
Changes in 123I-Ioflupane uptake, as measured by specific binding ratio (SBR), between baseline, year one, year two and year three.
Measured: Every year for three years
Secondary outcomes (4)
Diagnosis of PD or other synucleinopathies by the end of 3 years in the study population
Clinical evaluation
Measured: Every year for 3 years
Changes in 123I-MIBG late H/M
Changes in 123I-MIBG reuptake, as measured by late H/M ratio, between baseline and every six months for three years
Measured: Every 6 months for 3 years
Changes in 123I-MIBG WR rate
Changes in 123I-MIBG WR reuptake, as measured by WR rate, between baseline and every six months for three years
Measured: Every 6 months for 3 years
Sensitivity and specificity of DAT Scan compared to MIBG in predicting RBD conversion to PD/other synucleinopathies
Changes in 123I-Ioflupane uptake, as measured by specific binding ratio (SBR), between baseline, year one, year two and year three.
Measured: Every year for3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start30 Dec 2019
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for REM Sleep Behavior DisorderStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Tagliati, MD, Cedars-Sinai Medical Center
- Investigators
- Michele L Lima Gregorio, MD, FAAN, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218968
- Sponsor's protocol ID
- Study00000349
- Status last verified
- Nov 2025
- First submitted
- 26 Dec 2019
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Adrenergic Blocker Therapy on Cardiac and Striatal Transporter Uptake in Pre-Motor and Symptomatic Parkinson's Disease: A Follow up Study
- ClinicalTrials.gov ID
- NCT04218968
- Acronym / sponsor ID
- Study00000349
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 30 Dec 2019 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 6 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the long-term effects of treatment with the adrenergic blocker carvedilol on serial DaTscan, a dopamine transporter (DAT) single photon emission computerized tomography (SPECT) imaging technique in a population of subjects with defined pre-motor Parkinson's disease risks (i.e., REM sleep Behavior Disorder (RBD) and at least one among hyposmia, constipation, depression and color vision abnormality) and abnormal 123I-Metaiodobenzylguanidine (MIBG) scintigraphy.
Detailed description
Primary procedures in this study are MIBG scan, DAT scan, Neuromelanin Magnetic Resonance Imaging (NM-MRI), and carvedilol treatment. Subjects will return for research visits and imaging tests every six months for three years. We hypothesize that the rate of decline in DAT scan123I-Ioflupane uptake will be slower in subjects who have received the adrenergic blocker carvedilol, resulting in a decreased clinical phenoconversion rate to parkinsonism. If this is true, it might create a considerable window of opportunity for treatment with adrenergic blockers - or similar compounds able to reduce Sympathetic Nervous System (SNS) hyperactivity - which may result in long-term benefits such as delaying the neurodegenerative process and the onset of neurological symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| carvedilol therapy | Experimental | Drug: CarvedilolTwice daily oral doses of adrenergic blocker 12.5 mg or 25mg, according to patient tolerability. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Enrolled in the study "The Effect of Adrenergic Blocker Therapy on Cardiac and Striatal Transporter Uptake in Pre-Motor and Symptomatic Parkinson's Disease" (Pro#00053136)
- Capacity to give informed consent
Key exclusion criteria (23 listed)
- 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
- Contraindications to the use of carvedilol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarvedilolPrimary procedures in this study are MIBG scan, DAT scan, NM-MRI, and carvedilol titration. Subjects will return for research visits and imaging every six months for three years. The investigators hypothesize that the rate of decline in DAT scan123I-Ioflupane uptake will be slower in subjects who have received the adrenergic blocker carvedilol, resulting in a decreased clinical phenoconversion rate to parkinsonism. | Drug | carvedilol therapy |
Primary outcome
Changes in 123I-Ioflupane uptake - DATscan
Time frame: Every year for three years
Changes in 123I-Ioflupane uptake, as measured by specific binding ratio (SBR), between baseline, year one, year two and year three.
4 secondary outcomes
Diagnosis of PD or other synucleinopathies by the end of 3 years in the study population
Time frame: Every year for 3 years
Changes in 123I-MIBG late H/M
Time frame: Every 6 months for 3 years
Changes in 123I-MIBG WR rate
Time frame: Every 6 months for 3 years
Sensitivity and specificity of DAT Scan compared to MIBG in predicting RBD conversion to PD/other synucleinopathies
Time frame: Every year for3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele L Lima Gregorio, MD, FAAN principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carvedilol in people with REM Sleep Behavior Disorder and Pre-motor Parkinson Disease, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in 123I-Ioflupane uptake - DATscan (time frame: Every year for three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.