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

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

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.

Study Overview

• Status: Completed
• Conditions: REM Sleep Behavior Disorder; Neurodegeneration

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.

• Study Type: Observational
• Enrollment (Actual): 170

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Department of psychiatry, Faculty of Medicine, The Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
FDRs of idiopathic RBD patients; First-degree relatives of idiopathic RBD patients
FDRs of controls; First-degree relatives of controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Study Director: Shirley Xin Li, PhD, Hong Kong University

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2018
• Primary Completion (Actual): April 27, 2020
• Study Completion (Actual): April 27, 2020

Study Registration Dates

• First Submitted: August 30, 2018
• First Submitted That Met QC Criteria: September 12, 2018
• First Posted (Actual): September 14, 2018

Study Record Updates

• Last Update Posted (Actual): August 6, 2021
• Last Update Submitted That Met QC Criteria: August 5, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Neurodegeneration; REM sleep behavior disorder; Prodromal markers; α-synucleinopathy
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Nervous System Diseases; Sleep Wake Disorders; Neurodegenerative Diseases; Parasomnias; Proteostasis Deficiencies; REM Sleep Parasomnias; Mental Disorders; Synucleinopathies; Nerve Degeneration; REM Sleep Behavior Disorder
• Other Study ID Numbers: 24117018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Researcher in other sleep centers are also conducting similar study, there may be a plan for further collaboration on sharing the database