Parkinson DiseaseNCT05767151
Chinese DENOVO PD Registry
An observational study of Parkinson Disease, run by Xiangya Hospital of Central South University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 1 Jan 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Participants were diagnosed by MDS Clinical Diagnostic Criteria for PD
- Disease duration ≤ 2 years at baseline
- Hoehn-Yahr stage ≤2 at baseline
- The age of PD patients ranges from 30 to 75 years old
- Participants were naive to antiparkinsonian therapy
- Able to Written informed consent
Who cannot join
- Participants were diagnosed with parkinsonism-syndrome
- Participants were treated with antiparkinsonian drugs at baseline
- Participants with cognitive impairment
- Unable to Written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
Jifeng Guo, Ph.D, +8613974936815, guojifeng2003@163.com
Beisha Tang, MD, +8613974856709, bstang7398@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson Disease
- Keywords
- Motor symptoms, Nonmotor symptoms, Chinese longitudinal cohort, disease progression, biomarker
- Medical subject headings
- Parkinson Disease, Disease Progression
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from baseline to 10 years
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.
Measured: from baseline to 10 years
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.
Measured: from baseline to 10 years
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)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
Measured: from baseline to 10 years
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
Measured: from baseline to 10 years
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.
Measured: from baseline to 10 years
Epworth Sleepiness Scale evaluates excessive sleepiness
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 .
Measured: from baseline to 10 years
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.
Measured: from baseline to 10 years
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.
Measured: from baseline to 10 years
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.
Measured: from baseline to 10 years
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.
Measured: from baseline to 10 years
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.
Measured: from baseline to 10 years
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
Measured: from baseline to 10 years
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.
Measured: from baseline to 10 years
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.
Measured: from baseline to 10 years
Dyskinesia was evaluated by UPDRS part III
The presence of dyskinesia is evaluated by the doctor and recordsed.
Measured: from baseline to 10 years
Secondary outcomes (1)
Comparison between Rates of Change
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).
Measured: from baseline to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start1 Jan 2021
- Primary completion1 Jan 2031 (estimated)
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05767151
- Sponsor's protocol ID
- CPD-DENOVOR
- Status last verified
- Aug 2022
- First submitted
- 29 Aug 2022
- Last updated
- 14 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Chinese DENOVO Parkinson's Disease Registry
- ClinicalTrials.gov ID
- NCT05767151
- Acronym / sponsor ID
- CPD-DENOVOR
- Conditions
- Parkinson Disease
- Keywords
- Motor symptoms, Nonmotor symptoms, Chinese longitudinal cohort, disease progression, biomarker
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2031 (estimated)
- Study completion
- 1 Jan 2031 (estimated)
- First posted
- 14 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Participants were diagnosed by MDS Clinical Diagnostic Criteria for PD
- Disease duration ≤ 2 years at baseline
- Hoehn-Yahr stage ≤2 at baseline
- The age of PD patients ranges from 30 to 75 years old
- Participants were naive to antiparkinsonian therapy
Key exclusion criteria (4 listed)
- Participants were diagnosed with parkinsonism-syndrome
- Participants were treated with antiparkinsonian drugs at baseline
- Participants with cognitive impairment
- Unable to Written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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
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
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.
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 .
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.
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.
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.
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.
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.
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
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.
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.
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.
1 secondary outcome
Comparison between Rates of Change
Time frame: from baseline to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jifeng Guo, Ph.D (+8613974936815, guojifeng2003@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Unified Parkinson's Disease Rating Scale for evaluating motor subtypes (time frame: from baseline to 10 years). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.