Chinese DENOVO PD Registry

NCT05767151 | Recruiting

• 1 other identifier: CPD-DENOVOR
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Motor symptoms; Nonmotor symptoms; Chinese longitudinal cohort; disease progression; biomarker

Outcome Measures

Primary Outcomes (16)

• 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.

  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.

  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.

  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 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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  The presence of dyskinesia is evaluated by the doctor and recordsed.

  from baseline to 10 years

Secondary Outcomes (1)

• Comparison between Rates of Change

  from baseline to 10 years

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Participants were diagnosed with parkinsonism-syndrome
• Participants were treated with antiparkinsonian drugs at baseline
• Participants with cognitive impairment
• Unable to Written informed consent

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Extraction of DNA from peripheral blood of patients

MeSH Terms

Conditions

Parkinson Disease; Disease Progression

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jifeng Guo, Ph.D

CONTACT

+8613974936815; guojifeng2003@163.com

Beisha Tang, MD

CONTACT

+8613974856709; bstang7398@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: March 14, 2023
• Study Start: January 1, 2021
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2031
• Last Updated: March 14, 2023

Record last verified: 2022-08

Locations

CN (1)