Chinese PD Registry

Parkinson Disease Clinical Trial

— CPDR  

Official title:

The Chinese Parkinson's Disease Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03887663
• Other study ID #: CPDR
• Status: Recruiting
• Start date: February 1, 2017
• Est. completion date: February 1, 2027

Study information

• Verified date: December 2019
• Source: Xiangya Hospital of Central South University
• Contact: Qiying Sun, Ph.D
• Phone: +8615874907260
• Email: sunqiying2015[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: February 1, 2027
• Est. primary completion date: February 1, 2027
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Locations

Country	Name	City	State
China	Xiangya Hospital of Central South University	Changzhi	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Unified Parkinson's Disease Rating Scale for evaluating motor subtypes	The UPDRS is made up of four parts, 55 items in total. Total score varies from 0 to 199. Part I: evaluation of behavior and mood, which consists of 4 items, score varies from 0-16; Part II: self-evaluation of the activities of daily life, which consists of 13 items,score varies from 0-52; Part III: motor evaluation, which consists of 27 items, score varies from 0-108; Part IV: complications of therapy, which consists of 11 items,score varies from 0-23. All the patients are evaluated in "OFF" state. The ratio of the mean tremor score (scores of item-16, item-20, and item-21 will be added: ) to the mean postural instability/gait disorder (PIGD) score (scores of item-13, item-14, item-15, item-29, item-30 will be added: ) was used to classify motor subtype. Patients with a ratio value < 1.0 were defined as PIGD, and those with values from 1.0 to 1.5 were categorized as intermediate, while those with values =1.5 were classified as tremor dominant.	12±1 months
Primary	The clinical stage of PD is assessed by Hoehn and Yahr scale	The H-Y scale ranges from 1 to 5. Early PD is defined as H-Y stage 1 to 2.5, advanced PD is defined as H-Y stage 3-5.	12±1 months
Primary	Autonomic symptoms are evaluated by The Scale for outcomes in Parkinson disease for Autonomic Symptoms	This scale includes 25 items assessing the following regions: gastrointestinal (7 items), urinary (6 items), cardiovascular (3 items), thermoregulatory (4 items), pupillomotor (1 items), and sexual dysfunction(2 items for men and 2 items for women). Scores in each region should be added. The score of the answers ranges from 0 to 3 for each item and the total score ranges from 0 to 69, where higher scores reflect worse autonomic functioning.	12±1 months
Primary	The non-motor symptoms are evaluated by Non-motor Symptom Scale	This scale includes 30 items which is divided into 9 domains. Total score varies from 0-360. Higher score indicates severer symptoms. Domain 1 evaluates cardiovascular system symptoms. Score of domain 1 varies from 0-24. Domain 2 evaluates sleep condition. Score of domain 2 varies from 0-48. Domain 3 evaluates cognitive function. Score of domain 3 varies from 0-72. Domain 4 evaluates illusion. Score of domain 4 varies from 0-36. Domain 5 evaluates attention and memory. Score of domain 5 varies from 0-36. Domain 6 evaluates gastrointestinal symptoms. Score of domain 6 varies from 0-36. Domain 7 evaluates urinary symptoms. Score of domain 7 varies from 0-36. Domain 8 evaluate sensory symptoms. Score of domain 8 varies from 0-24. Domain 9 evaluates other non-motor symptoms. Score of domain 9 varies from 0-48.	12±1 months
Primary	Constipation was diagnosed by Functional Constipation Diagnostic Criteria Rome III.	The diagnostic criteria must include two or more of the following; Straining during at least 25% of defecations; Lumpy or hard stools in at least 25% of defecations; Sensation of incomplete evacuation for at least 25% of defecations; Sensation of anorectal obstruction/blockage for at least 25% of defecations; Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor); Fewer than three defecations per week 2. Loose stools are rarely present without the use of laxatives 3. Insufficient criteria for irritable bowel syndrome * Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis	12±1 months
Primary	The PDQ-39 was used to assess the quality of life.	This scale includes 39 items assessing the following regions: mobility (10 items), activities of daily living (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognitions (4 items), communications (3 items) and bodily discomfort (3 items). Alternatively, the sum of the scores can assess the overall health-related quality of life profile of the individual questioned. Scores in each region should be added. The score of the answers ranges from 0 to 4 for each item and the total score ranges from 0 to 116, where higher scores reflect worse life quality.	12±1 months
Primary	Sleep quality is evaluated by Parkinson's Disease Sleep Scale	This scale includes 15 items that address eight aspects of sleep disturbances in PD, including overall quality of night's sleep (item 1)), score of item 1 less than 6 is defined as sleep disorder. Score of all the questions will be summed. The score of the answers ranges from 0 to 10 for each item and the total score ranges from 0 to 150, where higher scores reflect better sleep condition.	12±1 months
Primary	Excessive sleepiness is evaluated by Epworth Sleepiness Scale	This scale includes 8 items. Score of all the questions will be summed. All items were rated on a 4-point scale (0-3), with a minimal score of 0, and maximum total score of 24. A higher score demonstrates more severe excessive daytime sleepiness. Participants were classified as showing excessive daytime sleepiness if their total score =10 .	12±1 months
Primary	Probable rapid eye movement sleep behavior disorder was diagnosed by Probable rapid eye movement sleep behavior disorder Questionnaire -Hongkong	This scale includes 13 items. Score of all the questions will be summed. Total score of the answers ranges from 0 to 100, where higher scores reflect severer rapid eye movement sleep behavior disorder.The optimal cutoff value for the overall scale is 17; subjects were classified as showing RBD when they reached the above score.	12±1 months
Primary	Restless leg syndrome (RLS) was diagnosed with the Cambridge Hopkins Restless Leg syndrome questionnaire	have, or have you had, recurrent uncomfortable feelings or sensations in your legs while you are sitting or lying down; have, or have you had, a recurrent need or urge to move your legs while you were sitting or lying down; more likely to have these feelings when you are resting; If you get up or move around when you have these feelings, these feelings get better; these feelings in your legs most likely to occur at mid-day or afternoon or evening or night; Simply changing leg position by itself once without continuing to move usually relieve these feelings usually don't relieves; These feelings are not or not always due to muscle cramps	12±1 months
Primary	Cognitive condition is assessed by Mini Mental State Examination	This scale includes 30 items. Score of all the questions will be summed. All items were rated on a 2-point scale (0-1), with a minimal score of 0, and maximum total score of 30. A higher score demonstrates more better cognitive condition. The definition of cognitive disorder differs in education level. For illiteracy, presence of cognitive impairment is defined as MMSE score. For those only receive elementary education, the cut-off value is 20. For other patients, presence of cognitive impairment was defined as MMSE scores less than 25.	12±1 months
Primary	Olfaction test was measured by Hyposmia Rating Scale	This scale includes 6 items. Score of all the questions will be summed. All items were rated on a 4-point scale (1-4), with a minimal score of 6, and maximum total score of 24. A higher score demonstrates more worse sense of olfaction. The cutoff value HRS is 22.5.	12±1 months
Primary	Depression was diagnosed by Hamilton and Montgomery-Asberg Depression Scale	This scale includes 17 items. Score of all the questions will be summed. Total score ranges from0-53. A higher score demonstrates more severer depression. The study participants were defined to be not depressed (scores 0-6) , to have minor depression(scores 7-14), or to have major depression (scores above 14) at the different visits during follow-up	12±1 months
Primary	Symptom of fatigue was measured by PD fatigue severity scale	This scale includes 9 items. Score of all the questions will be summed. All items were rated on a 7-point scale (1-7). Total score ranges from0-63. A higher score demonstrates more severer fatigue.	12±1 months
Primary	freezing gait by new freezing gait questionnaire scores	Parts II and III provides a total summed score between 0 and 28. Part II (items 2-6, scoring range 0-19) rated the severity of FOG based on its duration and frequency in its most common manifestation. Total score will be calculated for comparison.	12±1 months
Primary	Dyskinesia was evaluated by UPDRS part III	The presence of dyskinesia is evaluated by the doctor and recordsed.	12±1 months
Secondary	hypertension	Diastolic blood pressure =140 mmHg, or systolic blood pressure =90 mmHg in at least three different days; or self-reported hypertension diagnosed by physicians, or taking BP-lowering medications at baseline.	baseline
Secondary	Type II diabetes	Type II diabetes can be diagnosed if any of the requirements are met: The test result of serum Hemoglobin A1c level conducted in the hospital is higher than 6.5%, fasting plasma glucose level =7.0mmol/l, or oral glucose tolerance test results =11.1mmol/l, results confirmed by repeated testing, or random plasma glucose level =11.1mmol/l in a patient with classic symptoms of hyperglycemia or hyperglycemic crisis; or self-reported type II diabetes diagnosed by physicians, or taking hypoglycemic agent or insulin at baseline.	baseline
Secondary	Hyperlipidemia	Total cholesterol =6.2mmol/L or low-density lipoprotein =4.1mmol/L or triglyceride =2.3mmol/L; or self-reported hyperlipidemia diagnosed by physicians, or taking lipid-lowering drugs at baseline.	baseline