Cardiac Changes in Early Parkinson's Disease: A Follow up Study

NCT04218968 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: Study00000349
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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 (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.

Conditions

REM Sleep Behavior Disorder; Pre-motor Parkinson Disease; Symptomatic Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  Every year for three years

Secondary Outcomes (4)

• Diagnosis of PD or other synucleinopathies by the end of 3 years in the study population

  Every year for 3 years

• Changes in 123I-MIBG late H/M

  Every 6 months for 3 years

• Changes in 123I-MIBG WR rate

  Every 6 months for 3 years

• Sensitivity and specificity of DAT Scan compared to MIBG in predicting RBD conversion to PD/other synucleinopathies

  Every year for3 years

Other Outcomes (11)

• MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III

  Every 6 months for 3 years

• Non-Motor Symptoms Scale (NMSS) changes

  Every 6 months for 3 years

• Scales for Outcomes in Parkinson's Disease - Autonomic Dysfunction (SCOPA-AUT)

  Every 6 months for 3 years

Study Arms (1)

carvedilol therapy

EXPERIMENTAL

Twice daily oral doses of adrenergic blocker 12.5 mg or 25mg, according to patient tolerability.

Drug: Carvedilol

Interventions

Carvedilol DRUG

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.

carvedilol therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Michele L Lima Gregorio

Los Angeles, California, 90046, United States

Location

MeSH Terms

Conditions

REM Sleep Behavior Disorder; Parkinson Disease, Secondary

Interventions

Carvedilol

Condition Hierarchy (Ancestors)

REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring

Study Officials

• Michele L Lima Gregorio, MD, FAAN

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Vice Chairman, Director of Movement Disorders

Study Record Dates

• First Submitted: December 26, 2019
• First Posted: January 6, 2020
• Study Start: December 30, 2019
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 2, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)