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

Sponsors

Lead Sponsor: Chinese University of Hong Kong

Source 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.

Overall Status Recruiting
Start Date September 27, 2018
Completion Date August 31, 2021
Primary Completion Date August 31, 2021
Study Type Observational
Primary Outcome
Measure Time Frame
Changes of the overall probability of prodromal Parkinson's disease in the FDRs of patients with RBD. Baseline and 5 years
Secondary Outcome
Measure Time Frame
Changes of tonic EMG activity 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. Baseline and 5 years
New incidence of RBD and α-synucleinopathy in the FDRs of patients with RBD. Baseline and 5 years
Enrollment 260
Condition
Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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: All

Minimum Age: 40 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Overall Contact

Last Name: Jihui Zhang, PhD

Phone: (852)39197647

Email: [email protected]

Location
Facility: Status: Contact: Department of psychiatry, Faculty of Medicine, The Chinese University of Hong Kong Jihui Zhang, PhD
Location Countries

Hong Kong

Verification Date

February 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Chinese University of Hong Kong

Investigator Full Name: Dr. Zhang Jihui

Investigator Title: Assistant Professor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: FDRs of idiopathic RBD patients

Description: First-degree relatives of idiopathic RBD patients

Label: FDRs of controls

Description: First-degree relatives of controls

Patient Data Undecided
Study Design Info

Observational Model: Case-Control

Time Perspective: Prospective

Source: ClinicalTrials.gov