Progression of Prodromal Markers of α-synucleinopathy Neu... | NCT03671772

Studies
Progression of Prodromal Markers of α-synucleinopathy Neurodegeneration in the FDRs of Patients With RBD

NCT03671772

Sponsor

Chinese University of Hong Kong

Status

Completed

Last Update Posted

Aug 6, 2021Actual

Enrollment

170Actual

Phase

Not provided

Conditions

REM Sleep Behavior Disorder
Neurodegeneration

Interventions

Not provided

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 27, 2018Actual

Primary Completion Date

Apr 27, 2020Actual

Completion Date

Apr 27, 2020Actual

First Submitted Date

Aug 30, 2018

First Submission Date that Met QC Criteria

Sep 12, 2018

First Posted Date

Sep 14, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 5, 2021

Last Update Posted Date

Aug 6, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Zhang Jihui, Assistant Professor, Chinese University of Hong KongPrincipal Investigator

Lead Sponsor

Chinese University of Hong KongOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is a prospective study with a mean of 5-year follow-up interval, aims to monitor the progression of α-synucleinopathy neurodegeneration by the evolution of prodromal markers and development of clinical disorders in first-degree relatives (FDRs) of idiopathic REM Sleep Behavior Disorder (RBD) patients and healthy controls.

Detailed Description

Idiopathic RBD is implicated as an integral part of progression of α-synucleinopathy neurodegeneration, and patients with idiopathic RBD have increased prevalence of non-motor symptoms (or prodromal markers) closely related to Parkinson's disease(PD). Moreover, the investigator's previous studies have further confirmed the familial aggregation of RBD, and first-degree relatives (FDRs) of RBD patients had more prodromal markers of Parkinson's disease compared with FDRs of healthy controls.

In these regards, current prospective study aims to map the progression and evolution of prodromal markers (including autonomic dysfunction, olfactory loss, color vision impairment, neurocognitive impairment, neuroimaging of dopamine dysfunction, daytime sleepiness and psychiatric disorders), onset of RBD, and neurodegenerative diseases. Finally, other markers, such as physical activity and circadian rhythm and tonic electromyography (EMG) activity level, which have been found to be reliably associated with Parkinson's disease or other neurodegenerative diseases. In this regard, it is also interesting to investigate whether these indicators will additionally predict the progression of prodromal markers of PD.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

170Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FDRs of idiopathic RBD patients		First-degree relatives of idiopathic RBD patients
FDRs of controls		First-degree relatives of controls

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes of the overall probability of prodromal Parkinson's disease in the FDRs of patients with RBD.	Changes of the overall probability of prodromal Parkinson's disease will be calculated based on the Movement Disorder Society (MDS) research criteria for prodromal Parkinson's disease in the FDRs of patients with RBD.	Baseline and 5 years

Secondary Outcomes

Measure	Description	Time Frame
Changes of tonic EMG activity in the FDRs of patients with RBD.	Changes of tonic EMG activity is recorded by v-PSG in the FDRs of patients with RBD.	Baseline and 5 years
Changes of physical activity level and circadian in the FDRs of patients with RBD.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Chinese aged 40 or above;
Being capable of giving informed consent for participation of the study;
Sex-matched.

Exclusion Criteria:

Younger than 40 years old (as the supposed neurodegenerative process may not have occurred);
Not capable of giving informed consent for participation of the study.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The participants in this proposed study will be recruited from our on-going family cohort of RBD

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jihui Zhang, PhD	Chinese University of Hong Kong	Principal Investigator
Yun Kwok Wing, MBChB	Chinese University of Hong Kong	Study Director
Vincent Chung Tong Mok, MBChB	Chinese University of Hong Kong	Study Director
Shirley Xin Li, PhD	Hong Kong University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of psychiatry, Faculty of Medicine, The Chinese University of Hong Kong		Hong Kong			Hong Kong

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Researcher in other sleep centers are also conducting similar study, there may be a plan for further collaboration on sharing the database

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020187	REM Sleep Behavior Disorder
D009410	Nerve Degeneration

Ancestor Terms

ID	Term
D020923	REM Sleep Parasomnias
D020447	Parasomnias
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Description

Thyroid Function Tests(TFT), Vitamin B12, Folate, Complete Blood Count(CBC), Fasting Glucose, Liver Function Tests(LFT), Renal Function Tests(RFT), C-reactive protein(CRP), Fasting lipid, Iron profile, Phosphate, Calcium, Neurosteroid, Genetic analysis