Trials Sponsors Conditions Drugs Pricing

Conditions

Pre-motor Parkinson Disease REM Sleep Behavior Disorder 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
+8 more other outcomes

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

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.

carvedilol therapy

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Eligibility Criteria

Age18 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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

Sponsors & Collaborators

Cedars-Sinai Medical Center
Otherlead

Study Sites (1)

Michele L Lima Gregorio

Los Angeles, California, 90046, United States

MeSH Terms

Conditions

REM Sleep Behavior DisorderParkinson Disease, Secondary

Interventions

Carvedilol

Condition Hierarchy (Ancestors)

REM Sleep ParasomniasParasomniasSleep Wake DisordersNervous System DiseasesMental DisordersParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesMovement Disorders

Intervention Hierarchy (Ancestors)

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

Actual (reported)

Primary Completion

June 30, 2026

Estimated (date passed)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Other Outcomes (11)

Study Arms (1)

carvedilol therapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Other Outcomes (11)

Study Arms (1)

carvedilol therapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations