Chinese DENOVO PD Registry

March 1, 2023 updated by: Xiangya Hospital of Central South University

The Chinese DENOVO Parkinson's Disease Registry

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410008
        • Recruiting
        • Xiangya Hospital of Central South University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Unified Parkinson's Disease Rating Scale for evaluating motor subtypes
Time Frame: from baseline to 10 years
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.
from baseline to 10 years
The clinical stage of PD is assessed by Hoehn and Yahr scale
Time Frame: from baseline to 10 years
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.
from baseline to 10 years
The non-motor symptoms are evaluated by Non-motor Symptom Scale
Time Frame: from baseline to 10 years

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.
from baseline to 10 years
Constipation was diagnosed by Functional Constipation Diagnostic Criteria Rome III
Time Frame: from baseline to 10 years

The diagnostic criteria must include two or more of the following

  1. Straining during at least 25% of defecations
  2. Lumpy or hard stools in at least 25% of defecations
  3. Sensation of incomplete evacuation for at least 25% of defecations
  4. Sensation of anorectal obstruction/blockage for at least 25% of defecations
  5. Manual maneuvers to facilitate at least 25% of defecations (e.g., digital evacuation, support of the pelvic floor)f. 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
from baseline to 10 years
The PDQ-39 was used to assess the quality of life
Time Frame: from baseline to 10 years
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
from baseline to 10 years
Sleep quality is evaluated by Parkinson's Disease Sleep Scale
Time Frame: from baseline to 10 years
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.
from baseline to 10 years
Epworth Sleepiness Scale evaluates excessive sleepiness
Time Frame: from baseline to 10 years
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 .
from baseline to 10 years
Probable rapid eye movement sleep behavior disorder was diagnosed by Probable rapid eye movement sleep behavior disorder Questionnaire -Hongkong
Time Frame: from baseline to 10 years
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.
from baseline to 10 years
Olfaction test was measured by Hyposmia Rating Scale
Time Frame: from baseline to 10 years

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.
from baseline to 10 years
Cognitive condition is assessed by Mini Mental State Examination
Time Frame: from baseline to 10 years

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.
from baseline to 10 years
Depression was diagnosed by Hamilton and Montgomery-Asberg Depression Scale
Time Frame: from baseline to 10 years
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.
from baseline to 10 years
Autonomic symptoms are evaluated by The Scale for outcomes in Parkinson disease for Autonomic Symptoms
Time Frame: from baseline to 10 years
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.
from baseline to 10 years
Restless leg syndrome (RLS) was diagnosed with the Cambridge Hopkins Restless Leg syndrome questionnaire
Time Frame: from baseline to 10 years
  1. have, or have you had, recurrent uncomfortable feelings or sensations in your legs while you are sitting or lying down
  2. have, or have you had, a recurrent need or urge to move your legs while you were sitting or lying down
  3. more likely to have these feelings when you are resting
  4. If you get up or move around when you have these feelings, these feelings get better
  5. these feelings in your legs most likely to occur at mid-day or afternoon or evening or night
  6. Simply changing leg position by itself once without continuing to move usually relieve these feelings usually don't relieves
  7. These feelings are not or not always due to muscle cramps
from baseline to 10 years
Symptom of fatigue was measured by PD fatigue severity scale
Time Frame: from baseline to 10 years

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.
from baseline to 10 years
Freezing gait by new freezing gait questionnaire scores
Time Frame: from baseline to 10 years
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.
from baseline to 10 years
Dyskinesia was evaluated by UPDRS part III
Time Frame: from baseline to 10 years
The presence of dyskinesia is evaluated by the doctor and recordsed.
from baseline to 10 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Comparison between Rates of Change
Time Frame: from baseline to 10 years
Comparison between the rates of change in the mean of clinical outcomes in PD subtype, inluding postural instability/gait disorder (PIGD), intermediate, and tremor dominant (TD).
from baseline to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xiangya Hospital of Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2031

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 29, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CPD-DENOVOR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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