Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-29 @ 2:33 PM
Study NCT ID:
NCT04048603
Status:
UNKNOWN
Last Update Posted:
2021-08-06
First Post:
2019-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Search for Biomarkers of Neurodegenerative Diseases in Idiopathic REM Sleep Behavior Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020187', 'term': 'REM Sleep Behavior Disorder'}, {'id': 'D009410', 'term': 'Nerve Degeneration'}], 'ancestors': [{'id': 'D020923', 'term': 'REM Sleep Parasomnias'}, {'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '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'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 182}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-05', 'studyFirstSubmitDate': '2019-03-22', 'studyFirstSubmitQcDate': '2019-08-05', 'lastUpdatePostDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The overall conversion rate of iRBD to neurodegenerative diseases', 'timeFrame': 'Changes from baseline to 7 year follow up', 'description': '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.'}], 'secondaryOutcomes': [{'measure': "Changes of the likelihood ratio of probability of prodromal Parkinson's disease in each individual", 'timeFrame': 'Baseline and 7 year', 'description': "The dynamic changes of the likelihood ratio of probability of prodromal Parkinson's disease in the patients with iRBD and healthy controls will be calculated based on the Movement Disorder Society (MDS) research criteria for prodromal Parkinson's disease."}, {'measure': "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", 'timeFrame': 'Changes from baseline to 7 year follow up', 'description': "Conversion rate of iRBD to neurodegenerative diseases in patients with high and low likelihood ratio of probability at baseline, the level of likelihood ratio was defined based on the Movement Disorder Society (MDS) research criteria for prodromal Parkinson's disease."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['REM sleep behavior disorder', 'Neurodegeneration', 'α-synucleinopathy', 'Prodromal markers'], 'conditions': ['REM Sleep Behavior Disorder', 'Neurodegeneration']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "REM sleep behavior disorder (RBD) is a parasomnia characterized by dream enactment behaviors and REM sleep without muscle atonia (excessive EMG activity) during REM sleep.Increasing studies revealed that iRBD eventually converts to α-synucleinopathy, such as Parkinson's disease (PD), dementia with Lewy Bodies (DLB), and multiple system atrophy (MSA). Recent studies reported that over 80% of patients with iRBD eventually developed neurodegeneration at a mean interval of 14 years after iRBD onset or diagnosed. Thus, iRBD is regarded as a precursor of α-synucleinopathies. In addition to iRBD, a large series of other non-motor symptoms also present before the emergence of typical motor symptoms of PD, including autonomic dysfunction, olfactory loss, color vision impairment, neurocognitive impairment,neuroimaging of dopamine dysfunction, daytime sleepiness, and psychiatric disorders. In recent years, several longitudinal studies have found that patients with iRBD with a higher rate of these markers may have a faster progression of neurodegeneration. On the other hand, a variety of external risk factors of PD including environmental toxic exposure, lifestyle factors, and some medications have long been recognized, which affect numerous fundamental cellular processes by interaction with genetic predisposition.\n\nHowever, several knowledge gaps still need further studies to uncover. First, few studies have explored the predictive value of dynamic change of biomarkers in prodromal stage of PD. Second, few previous prospective studies also employed a control group to compare the change of these prodromal markers between patients and healthy controls over time. Third, as some of previous studies employed a retrospective study design, potential recall bias may contaminate the results. Moreover, the sample sizes of most previous studies investigating biomarkers were relative small (n \\< 80) and follow-up durations in most study are relatively short, which may have limited the statistical power to detect the risk factors with mild to moderate effect size. Finally, as previous reported longitudinal studies of iRBD mainly focused on Caucasian or other ethnic groups, there is only limited data about neurodegenerative biomarkers in Chinese iRBD. In conclusion, prospective longitudinal studies with larger sample size, regular follow-up, and relative long follow-up duration are needed to better map the progression of neurodegeneration."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The participants in this proposed study will be recruited from our on-going cohort of RBD and control', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nfor iRBD at baseline:\n\n1. 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;\n2. Having neurocognitive test and neurological examination since 2008;\n3. Free of neurodegenerative diseases at the last visit.\n\nfor controls without iRBD at baseline:\n\n1. Age- and sex- matched with patients with iRBD;\n2. Free of narcolepsy and other neurological diseases;\n3. Without any RBD features as confirmed by both clinical history and video-PSG;\n4. Without neurodegenerative diseases;\n5. Having neurocognitive test and neurological examination at baseline.\n\nExclusion Criteria:\n\n1. Patients with narcolepsy;\n2. Patients with known neurodegenerative diseases;\n3. Pseudo-RBD (e.g., RBD symptoms were eliminated after severe obstructive sleep apnea had treated with continuous positive airway pressure therapy.);\n4. Early-onset RBD (e.g., before the age of 50 years old) which might have a different pathogenesis from iRBD.'}, 'identificationModule': {'nctId': 'NCT04048603', 'briefTitle': 'Search for Biomarkers of Neurodegenerative Diseases in Idiopathic REM Sleep Behavior Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'A 7-year Prospective Study of Idiopathic REM Sleep Behavior Disorder Cohort in Chinese Population: Determining the Optimal Characteristics of Biomarkers to Predict Neurodegenerative Diseases', 'orgStudyIdInfo': {'id': '2018.641'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'idiopathic REM sleep behavior disorder', 'description': 'Subjects with the diagnosis of idiopathic REM sleep behavior disorder'}, {'label': 'Controls without iRBD', 'description': 'Healthy controls without the diagnosis of idiopathic REM sleep behavior disorder'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'status': 'RECRUITING', 'country': 'Hong Kong', 'contacts': [{'name': 'Jihui Zhang, PhD', 'role': 'CONTACT'}], 'facility': 'Department of psychiatry, Faculty of Medicine, The Chinese University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'centralContacts': [{'name': 'Jihui Zhang, PhD', 'role': 'CONTACT', 'email': 'jihui.zhang@cuhk.edu.hk', 'phone': '(852)39197647'}], 'overallOfficials': [{'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': 'Yaping Liu, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chinese University of Hong Kong'}, {'name': 'Siu Ping Lam, MBChB', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chinese University of Hong Kong'}, {'name': 'Shirley Xin Li, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The University of Hong Kong'}, {'name': 'Vincent Chung Tong Mok, MBChB', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Researcher in other sleep centers are also conducting similar study, there may be a plan for further collaboration on sharing the database'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Zhang Jihui', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}