Trial · NCT03775096
Adrenergic Blockers for Cardiac Changes in Early Parkinson's Disease (Protocol 53136)
NCT03775096, Phase 2, Active not recruiting, Michele Tagliati, MD
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Adrenergic Blockers for Cardiac Changes in Early Parkinson's Disease (Protocol 53136). Trials, record NCT03775096. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03775096
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Adrenergic Blockers for Cardiac Changes in Early Parkinson's Disease (Protocol 53136)
- NCT number
- NCT03775096
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 15 participants, estimated
- Lead sponsor
- Michele Tagliati, MD
- Conditions
- REM Sleep Behavior Disorder, Pre-motor Parkinson Disease, Symptomatic Parkinson Disease
- Interventions
- Carvedilol
- First posted
- 2018-12-13
- Last updated
- 2026-03-02
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 123I-MIBG reuptake changes | At baseline and at 26 weeks of treatment. | 123I-MIBG reuptake will be measured by early and late Heart to Mediastinal ratio (H/M) and Washout ratio (WR) which will be calculated using the following formula: \[(early heart counts/pixel - early mediastinum counts/pixel) - (late heart counts/pixel decay-corrected - late mediastinum counts/pixel decay-corrected)\]/(early heart counts/pixel - early mediastinum counts/pixel). Care will be taken to exclude lung or liver from the myocardial and large vessels and lung from the mediastinum region of interest. MIBG abnormality cutoffs will be set for values of late H/M \<2.2 and WR \>30%. |
| Secondary | Adverse Events frequency | every 3 months up to 34 weeks | Safety will be monitored collecting the type and frequency of adverse events, including clinical symptoms, changes in vital signs, clinical laboratory measures and EKG abnormalities. |
| Secondary | Heart rate variability changes | At baseline and at 26 weeks of treatment. | Twenty-four-hour Holter monitoring of all patients will be conducted at two points during the study: 1) After MIBG and prior to the administration of the study drug and 2) within one week of the end of the six-month treatment trial. Two-channel Holter recordings will obtained and analyzed on a commercially available scanner in the cardiac laboratory at Cedars Sinai Medical Center, according to published guidelines. |
| Other | MDS-UPDRS part III changes | At baseline and at 26 weeks of treatment. | The Movement disorder society-unified Parkinson's disease rating scale (MDS-UPDRS) Part III will be administered at baseline and 26 weeks after study medication titration. Each item of the MDS-UPDRS has a possible rating from 0 to 4, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.Clinical scales will be performed OFF medication in those subjects that might be receiving dopaminergic drugs |
| Other | Sleep changes as measured by REM Behavior Disorder questionnaire | At baseline and at 26 weeks of treatment. | RBD questionnaire (RBDSQ) changes from Screening at 26 weeks after study drug titration |
| Other | Smell changes as measured by University of Pennsylvania Smell Identification Test (UPSIT) | At baseline and at 26 weeks of treatment. | University of Pennsylvania Smell Identification Test (UPSIT) changes from screening at 26 weeks after study medication titration |
| Other | Constipation score changes using a questionnaire based on modified ROME III diagnostic criteria | At baseline and at 26 weeks of treatment. | Functional constipation will be assessed at screening and at 26 weeks after study medication titration using a questionnaire based on modified ROME III diagnostic criteria, which focuses on symptoms including straining, lumpy or hard stools, sensation of incomplete evacuation, sensation of anorectal obstruction or blockage, manual maneuvers to facilitate evacuation, and two or fewer bowel movements per week. This questionnaire is based on a six item self-report measures with a three point summated rating scale. The total score has a range of 0 to 12, with scores \> 4 identifying functional constipation. |
| Other | Color vision changes as measured by HRR Pseudochromatic Plates | At baseline and at 26 weeks of treatment. | Color vision changes will be assessed using HRR Pseudochromatic Plates from screening at 26 weeks after study medication titration |
| Other | DAT scan Changes | At baseline and at 26 weeks of treatment. | DaT/SPECT uptake at baseline will be quantified at baseline and 26 weeks after study medication titration |
| Other | Non-Motor Symptoms Scale (NMSS) changes | At baseline and at 26 weeks of treatment. | The NMSS measures non-motor symptoms over the previous month. Each symptom is scored with respect to: Severity: 0 = None, 1 = Mild; 2 = Moderate; 3 = Severe and Frequency: 1 = Rarely (\<1/wk); 2 = Often (1/wk); 3 = Frequent (several times per week); 4 = Very Frequent (daily or all the time). |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers59
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03775096
GET https://conductscience.org/api/trials/v1/NCT03775096/papers?page=2