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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03671772
Other study ID # 24117018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 27, 2018
Est. completion date April 27, 2020

Study information

Verified date August 2021
Source Chinese University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 170
Est. completion date April 27, 2020
Est. primary completion date April 27, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years and older
Eligibility 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


Locations

Country Name City State
Hong Kong Department of psychiatry, Faculty of Medicine, The Chinese University of Hong Kong Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Changes of tonic EMG activity in the FDRs of patients with RBD. Changes of tonic EMG activity is recorded by v-PSG in the FDRs of patients with RBD. Baseline and 5 years
Secondary Changes of physical activity level and circadian in the FDRs of patients with RBD. Changes of physical activity level and circadian are recorded by one-week actigraphy in the FDRs of patients with RBD. Baseline and 5 years
Secondary New incidence of RBD and a-synucleinopathy in the FDRs of patients with RBD. New incidence of probable RBD, video-polysomnography (v-PSG) confirmed definite RBD and a-synucleinopathies in the FDRs of patients with RBD. Baseline and 5 years
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