Clinical trial NCT05767151: Chinese DENOVO PD Registry
Official title: The Chinese DENOVO Parkinson's Disease Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Keywords: Motor symptoms
Nonmotor symptoms
Chinese longitudinal cohort
disease progression
biomarker
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 300
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study Population: Most of the PD patients come from mainland China, especially from Hunan Province, Hubei Province, Jiangxi Province and Guizhou Province. The age of PD patients ranges from 30 to 75 years old.

Brief summary: The main objective of this longitudinal, multi-center study is to explore the clinical characteristics of PD and confirm biomarkers for PD evolution or progression.

Detailed description: Parkinson's disease (PD) is a common neurodegenerative disease, characterized by classical motor features including tremor, rigidity, bradykinesia, postural instability and a wide range of non-motor symptoms. Notably, a good deal of research revealed that PD is heterogeneous in clinical manifestations, rate of progression and prognosis. It is crucial to acknowledge the marked heterogeneity of PD and establish compelling biomarkers to predict the disease progression and prognosis. In past decades, there were substantial studies focused on defining the biomarkers of PD, which substantially contributed to improving our knowledge of PD. However, the pathology and clinical heterogeneity of PD are still poorly understood and controversial. Moreover, the information about reliable and well-validated biomarkers for PD has not yet been investigated thoroughly. Investigators aim to characterize the clinical feature, genetic basis, environmental factors and their interactions among different PD subtypes in China, and identify promising biomarkers for PD 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 visit 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's disease for Autonomic Symptoms (SCOPA-AUT). Constipation was diagnosed by Functional Constipation Diagnostic Criteria Rome. The 39-item Parkinson's Disease Questionnaire (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). Cognition was used by the previously validated scale, Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA). Olfaction test was carried out by Hyposmia Rating Scale (HRS), and 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 were extracted from peripheral blood and detected by Whole Exome Sequencing or Whole-genome sequencing. Plasma was obtained from venepuncture. All the participants were scanned by structural MRI to exclude obvious intracranial lesions and other parkinsonism such as MSA, PSP and WD.

Eligibility criteria: Inclusion Criteria:

1. Participants were diagnosed by MDS Clinical Diagnostic Criteria for PD
2. Disease duration ≤ 2 years at baseline
3. Hoehn-Yahr stage ≤2 at baseline
4. The age of PD patients ranges from 30 to 75 years old
5. Participants were naive to antiparkinsonian therapy
6. Able to Written informed consent

Exclusion Criteria:

1. Participants were diagnosed with parkinsonism-syndrome
2. Participants were treated with antiparkinsonian drugs at baseline
3. Participants with cognitive impairment
4. Unable to Written informed consent

Primary outcomes:
measure: The Unified Parkinson's Disease Rating Scale for evaluating motor subtypes
timeFrame: from baseline to 10 years
measure: The clinical stage of PD is assessed by Hoehn and Yahr scale
timeFrame: from baseline to 10 years
measure: The non-motor symptoms are evaluated by Non-motor Symptom Scale
timeFrame: from baseline to 10 years
measure: Constipation was diagnosed by Functional Constipation Diagnostic Criteria Rome III
timeFrame: from baseline to 10 years
measure: The PDQ-39 was used to assess the quality of life
timeFrame: from baseline to 10 years
measure: Sleep quality is evaluated by Parkinson's Disease Sleep Scale
timeFrame: from baseline to 10 years
measure: Epworth Sleepiness Scale evaluates excessive sleepiness
timeFrame: from baseline to 10 years
measure: Probable rapid eye movement sleep behavior disorder was diagnosed by Probable rapid eye movement sleep behavior disorder Questionnaire -Hongkong
timeFrame: from baseline to 10 years
measure: Olfaction test was measured by Hyposmia Rating Scale
timeFrame: from baseline to 10 years
measure: Cognitive condition is assessed by Mini Mental State Examination
timeFrame: from baseline to 10 years
measure: Depression was diagnosed by Hamilton and Montgomery-Asberg Depression Scale
timeFrame: from baseline to 10 years
measure: Autonomic symptoms are evaluated by The Scale for outcomes in Parkinson disease for Autonomic Symptoms
timeFrame: from baseline to 10 years
measure: Restless leg syndrome (RLS) was diagnosed with the Cambridge Hopkins Restless Leg syndrome questionnaire
timeFrame: from baseline to 10 years
measure: Symptom of fatigue was measured by PD fatigue severity scale
timeFrame: from baseline to 10 years
measure: Freezing gait by new freezing gait questionnaire scores
timeFrame: from baseline to 10 years
measure: Dyskinesia was evaluated by UPDRS part III
timeFrame: from baseline to 10 years
Secondary outcomes:
measure: Comparison between Rates of Change
timeFrame: from baseline to 10 years
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
Study officials:
References: