Clinical trial NCT03671772: Progression of Prodromal Markers of α-synucleinopathy Neurodegeneration in the FDRs of Patients With RBD
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: REM Sleep Behavior Disorder
Neurodegeneration
Keywords: α-synucleinopathy
Neurodegeneration
Prodromal markers
REM sleep behavior disorder
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 170
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants in this proposed study will be recruited from our on-going family cohort of RBD

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.

Eligibility 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.

Primary outcomes:
measure: Changes of the overall probability of prodromal Parkinson's disease in the FDRs of patients with RBD.
timeFrame: Baseline and 5 years
Secondary outcomes:
measure: Changes of tonic EMG activity in the FDRs of patients with RBD.
timeFrame: Baseline and 5 years
measure: Changes of physical activity level and circadian in the FDRs of patients with RBD.
timeFrame: Baseline and 5 years
measure: New incidence of RBD and α-synucleinopathy in the FDRs of patients with RBD.
timeFrame: Baseline and 5 years
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of psychiatry, Faculty of Medicine, The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Jihui Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese University of Hong Kong
name: Yun Kwok Wing, MBChB
role: STUDY_DIRECTOR
affiliation: Chinese University of Hong Kong
name: Vincent Chung Tong Mok, MBChB
role: STUDY_DIRECTOR
affiliation: Hong Kong University
name: Shirley Xin Li, PhD
role: STUDY_DIRECTOR
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