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

NCT03671772 | Completed

• 1 other identifier: 24117018
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

REM Sleep Behavior Disorder; Neurodegeneration

Keywords

α-synucleinopathy; Neurodegeneration; Prodromal markers; REM sleep behavior disorder

Outcome Measures

Primary Outcomes (1)

• 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 (3)

• 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

Study Arms (2)

FDRs of idiopathic RBD patients

First-degree relatives of idiopathic RBD patients

FDRs of controls

First-degree relatives of controls

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

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

Hong Kong, Hong Kong

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

REM Sleep Behavior Disorder; Nerve Degeneration

Condition Hierarchy (Ancestors)

REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: September 14, 2018
• Study Start: September 27, 2018
• Primary Completion: April 27, 2020
• Study Completion: April 27, 2020
• Last Updated: August 6, 2021

Record last verified: 2021-08

Locations

HK (1)