Clinical trial NCT03887663: Chinese PD Registry
Official title: The Chinese Parkinson's Disease Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Keywords: Motor symptoms
Nonmotor symptoms
Chinese longitudinal cohort
Natural history
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2019-03-25
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Most of the PD patients comes from mainland China, especially from Hunan Province, Hubei Province, Jiangxi Province and Guizhou Province. The proportion of male patients is slightly dominant than that of female patients. The age of PD patients ranges from 13 to more than 90 years old.

Brief summary: The purpose of the Chinese Parkinson's disease Registry (CPDR) is to develop a database of patients with Parkinson's disease in China.

Detailed description: Parkinson's disease (PD) is the second most common disorder among degenerative neurological diseases. PD is a complicated disease which consists of different subtypes. A certain type of parkinsonism has its unique clinical feature and genetic basis. Standards of classification and prognosis in different PD subtypes are still poorly understood. Investigators aim to establish a database of longitudinal recruited PD cohort ,and characterize the clinical feature, genetic basis, environmental factors and their interactions among different PD subtypes in China, identify natural history of a highly-presentative Chinese PD cohort and to discern major milestones in the disease process which indicates disease progression.

Data were collected at baseline, 12±1 months during the routine follow-up visits. Information about detailed disease history, level of education, significant chronic comorbidities, physical examination, medication history, family history, living habits and toxic exposure history, which include smoking, drinking tea, alcoholic consumption, drinking coffee, exposure to pesticide or occupational solvent, history of carbon monoxide poisoning and recurrent head trauma will be recorded at baseline. For each evaluation, the same questionnaires will be conducted. A standardized neurological assessment according to the recommendation of Consensus on the construction of clinical database of Parkinson's disease and movement disorders in China. The Unified Parkinson's Disease Rating Scale (UPDRS) part III is conducted for motor assessment, all the patients are evaluated in "OFF" state. The clinical stage of PD is assessed by Hoehn and Yahr scale (H-Y). The non-motor symptoms are evaluated by Non-motor Symptom Scale (NMSS), autonomic symptoms are evaluated by The Scale for outcomes in Parkinson disease for Autonomic Symptoms (SCOPA-AUT). Constipation was diagnosed by Functional Constipation Diagnostic Criteria Rome Ⅲ. The 39-item Parkinson's Disease Qestionnaire (PDQ-39) was used to assess the quality of life. Sleep quality was evaluated by Parkinson's Disease Sleep Scale (PDSS) and excessive daytime sleepiness by Epworth Sleepiness Scale (ESS). Probable rapid eye movement sleep behavior disorder (p-RBD) was diagnosed by rapid eye movement sleep behavior questionnaire-Hongkong (RBDQ-HK). Restless leg syndrome (RLS) was diagnosed with the Cambridge Hopkins Restless Leg syndrome questionnaire (CH-RLSq). Cognitive assessment was used the previously validated scale, Mini Mental State Examination (MMSE). Olfaction test was carried out by Hyposmia Rating Scale (HRS), a proportion of patients was also ascertained by Sniffin's Sticks. Depression was diagnosed by Hamilton Depression Scale (HAMD). Symptom of fatigue was measured by PD fatigue severity scale (PFS). Wearing-off was evaluated by WOQ-9 and freezing gait by new freezing gait questionnaire scores (NFOGQ). Dyskinesis was evaluated by Rush Dyskinesia Rating Scale. DNA samples extracted from peripheral blood and all the PD patients will be examed by Whole Exome Sequencing or Whole-genome sequencing. All the participants are scanned by structural MRI to exclude obvious intracranial lesions and other parkinsonism such as MSA, PSP and WD.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with PD by UK Brain Bank Diagnostic Criteria and other standard criteria.

Exclusion Criteria:

* Lack of capacity to consent to participate in the project

Primary outcomes:
measure: The Unified Parkinson's Disease Rating Scale for evaluating motor subtypes
timeFrame: 12±1 months
measure: The clinical stage of PD is assessed by Hoehn and Yahr scale
timeFrame: 12±1 months
measure: Autonomic symptoms are evaluated by The Scale for outcomes in Parkinson disease for Autonomic Symptoms
timeFrame: 12±1 months
measure: The non-motor symptoms are evaluated by Non-motor Symptom Scale
timeFrame: 12±1 months
measure: Constipation was diagnosed by Functional Constipation Diagnostic Criteria Rome III.
timeFrame: 12±1 months
measure: The PDQ-39 was used to assess the quality of life.
timeFrame: 12±1 months
measure: Sleep quality is evaluated by Parkinson's Disease Sleep Scale
timeFrame: 12±1 months
measure: Excessive sleepiness is evaluated by Epworth Sleepiness Scale
timeFrame: 12±1 months
measure: Probable rapid eye movement sleep behavior disorder was diagnosed by Probable rapid eye movement sleep behavior disorder Questionnaire -Hongkong
timeFrame: 12±1 months
measure: Restless leg syndrome (RLS) was diagnosed with the Cambridge Hopkins Restless Leg syndrome questionnaire
timeFrame: 12±1 months
measure: Cognitive condition is assessed by Mini Mental State Examination
timeFrame: 12±1 months
measure: Olfaction test was measured by Hyposmia Rating Scale
timeFrame: 12±1 months
measure: Depression was diagnosed by Hamilton and Montgomery-Asberg Depression Scale
timeFrame: 12±1 months
measure: Symptom of fatigue was measured by PD fatigue severity scale
timeFrame: 12±1 months
measure: freezing gait by new freezing gait questionnaire scores
timeFrame: 12±1 months
measure: Dyskinesia was evaluated by UPDRS part III
timeFrame: 12±1 months
Secondary outcomes:
measure: hypertension
timeFrame: baseline
measure: Type II diabetes
timeFrame: baseline
measure: Hyperlipidemia
timeFrame: baseline
Other outcomes:
Locations:
city: Changzhi
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
Study officials:
References: