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Completed

NCT Number: NCT03671772

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

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Changes of the overall probability of prodromal Parkinson's disease in the FDRs of patients with RBD.

    Time frame: Baseline and 5 years

    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.

Secondary outcomes

  1. Changes of tonic EMG activity in the FDRs of patients with RBD.

    Time frame: Baseline and 5 years

    Changes of tonic EMG activity is recorded by v-PSG in the FDRs of patients with RBD.

  2. Changes of physical activity level and circadian in the FDRs of patients with RBD.

    Time frame: Baseline and 5 years

    Changes of physical activity level and circadian are recorded by one-week actigraphy in the FDRs of patients with RBD.

  3. New incidence of RBD and α-synucleinopathy in the FDRs of patients with RBD.

    Time frame: Baseline and 5 years

    New incidence of probable RBD, video-polysomnography (v-PSG) confirmed definite RBD and α-synucleinopathies in the FDRs of patients with RBD.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 14, 2018
Registry last updated
Aug 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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