Search for Biomarkers of Neurodegenerative Diseases in Idiopathic REM Sleep Behavior Disorder

NCT04048603 | Unknown

• 1 other identifier: 2018.641
• Study Type: observational
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective study with a mean of 7-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 patients with idiopathic REM Sleep Behavior Disorder (iRBD) and healthy controls.

Conditions

REM Sleep Behavior Disorder; Neurodegeneration

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The overall conversion rate of iRBD to neurodegenerative diseases

  The overall conversion rate of iRBD to neurodegenerative diseases. The diagnoses of neurodegenerative diseases will be ascertained by neurologists according to the standard diagnostic criteria.

  Changes from baseline to 7 year follow up

Secondary Outcomes (2)

• Changes of the likelihood ratio of probability of prodromal Parkinson's disease in each individual

  Baseline and 7 year

• Conversion rate of iRBD to neurodegenerative diseases in patients with high and low likelihood ratio of probability of prodromal Parkinson's disease in each individual

  Changes from baseline to 7 year follow up

Study Arms (2)

idiopathic REM sleep behavior disorder

Subjects with the diagnosis of idiopathic REM sleep behavior disorder

Controls without iRBD

Healthy controls without the diagnosis of idiopathic REM sleep behavior disorder

Eligibility Criteria

• Age: 50 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 cohort of RBD and control

You may qualify if:

• for iRBD at baseline:
• Fulfilling the diagnostic criteria for iRBD. As patients with iRBD were recruited during a long period, the diagnosis of RBD was based on ICSD and ICSD-2 (before 2014), and ICSD-3 (2014 and thereafter) criteria. The diagnosis for all patients were confirmed by video-PSG. In summary, patient diagnosed with RBD should present excessive EMG activity during REM sleep on video-PSG assessment and report a history of repeated dream enactment behaviors;
• Having neurocognitive test and neurological examination since 2008;
• Free of neurodegenerative diseases at the last visit.
• for controls without iRBD at baseline:
• Age- and sex- matched with patients with iRBD;
• Free of narcolepsy and other neurological diseases;
• Without any RBD features as confirmed by both clinical history and video-PSG;
• Without neurodegenerative diseases;
• Having neurocognitive test and neurological examination at baseline.

You may not qualify if:

• Patients with narcolepsy;
• Patients with known neurodegenerative diseases;
• Pseudo-RBD (e.g., RBD symptoms were eliminated after severe obstructive sleep apnea had treated with continuous positive airway pressure therapy.);
• Early-onset RBD (e.g., before the age of 50 years old) which might have a different pathogenesis from iRBD.

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

RECRUITING

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

• Yaping Liu, PhD

  Chinese University of Hong Kong

  STUDY DIRECTOR

• Siu Ping Lam, MBChB

  Chinese University of Hong Kong

  STUDY DIRECTOR

• Shirley Xin Li, PhD

  The University of Hong Kong

  STUDY DIRECTOR

• Vincent Chung Tong Mok, MBChB

  Chinese University of Hong Kong

  STUDY DIRECTOR

Central Study Contacts

Jihui Zhang, PhD

CONTACT

(852)39197647; jihui.zhang@cuhk.edu.hk

Study Design

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

Study Record Dates

• First Submitted: March 22, 2019
• First Posted: August 7, 2019
• Study Start: May 15, 2019
• Primary Completion: March 31, 2022
• Study Completion: October 1, 2022
• Last Updated: August 6, 2021

Record last verified: 2021-08

Locations

HK (1)