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

Overview

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.

Full Title of Study: “Progression of Prodromal Markers of α-synucleinopathy Neurodegeneration in the First-degree Relatives of Patients With REM Sleep Behavior Disorder: a 5-year Prospective Study”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 27, 2020

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.

Arms, Groups and Cohorts

  • FDRs of idiopathic RBD patients
    • First-degree relatives of idiopathic RBD patients
  • FDRs of controls
    • First-degree relatives of controls

Clinical Trial Outcome Measures

Primary Measures

  • Changes of the overall probability of prodromal Parkinson’s disease in the FDRs of patients with RBD.
    • Time Frame: Baseline and 5 years
    • 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.

Secondary Measures

  • Changes of tonic EMG activity in the FDRs of patients with RBD.
    • Time Frame: Baseline and 5 years
    • Changes of tonic EMG activity is recorded by v-PSG in the FDRs of patients with RBD.
  • Changes of physical activity level and circadian in the FDRs of patients with RBD.
    • Time Frame: Baseline and 5 years
    • Changes of physical activity level and circadian are recorded by one-week actigraphy in the FDRs of patients with RBD.
  • New incidence of RBD and α-synucleinopathy in the FDRs of patients with RBD.
    • Time Frame: Baseline and 5 years
    • New incidence of probable RBD, video-polysomnography (v-PSG) confirmed definite RBD and α-synucleinopathies in the FDRs of patients with RBD.

Participating in This Clinical Trial

Inclusion Criteria

1. Chinese aged 40 or above; 2. Being capable of giving informed consent for participation of the study; 3. Sex-matched. Exclusion Criteria:

1. Younger than 40 years old (as the supposed neurodegenerative process may not have occurred); 2. Not capable of giving informed consent for participation of the study.

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Chinese University of Hong Kong
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Zhang Jihui, Assistant Professor – Chinese University of Hong Kong
  • Overall Official(s)
    • Jihui Zhang, PhD, Principal Investigator, Chinese University of Hong Kong
    • Yun Kwok Wing, MBChB, Study Director, Chinese University of Hong Kong
    • Vincent Chung Tong Mok, MBChB, Study Director, Chinese University of Hong Kong
    • Shirley Xin Li, PhD, Study Director, Hong Kong University

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