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

Completed

• Conditions: REM Sleep Behavior Disorder; Neurodegeneration

• Registration Number: NCT03671772
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study First Submitted: 2018-08-30
• Study First Submitted QC: 2018-09-12
• Study First Posted: 2018-09-14
• Study Start: 2018-09-27
• Primary Completion: 2020-04-27
• Study Completion: 2020-04-27
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-05
• Last Update Posted: 2021-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes of the overall probability of prodromal Parkinson's disease in the FDRs of patients with RBD.	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 Outcome Measures

Name	Time	Method
Changes of tonic EMG activity in the FDRs of patients with RBD.	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.	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.	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.

Trial Locations

Locations (1)

Department of psychiatry, Faculty of Medicine, The Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong