Chinese PD-LRRK2 Registry
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| ClinicalTrials.gov Identifier: NCT03523104 |
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Recruitment Status :
Recruiting
First Posted : May 14, 2018
Last Update Posted : May 29, 2018
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Sponsor:
Xiangya Hospital of Central South University
Information provided by (Responsible Party):
Xiangya Hospital of Central South University
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Brief Summary:
The purpose of the Chinese PD-LRRK2 Registry(CPD-LRRK2R) is to develop a database of patients of Parkinson's disease with leucine-rich repeat kinase 2 (LRRK2) gene variants in mainland China.
| Condition or disease |
|---|
| Parkinson Disease |
Parkinson's disease (PD) is the second most common disorder among neurodegenerative diseases. LRRK2 missense mutations are the most common known genetic cause of PD. However, some polymorphisms of LRRK2 such as G2385R and R1628P can also affect the risk of developing PD. The investigators aim to establish a database of PD with LRRK2 variants and characterize the clinical manifestation of these patients in mainland China.
Method:
- Peripheral blood from patients has been tested to have LRRK2 gene variants.
- Clinical manifestation will be measured by scales and neurological tests. Standard scales include: Unified Parkinson's Disease Rating Scale(UPDRS), Hoehn-Yahr stages, Non-Motor Symptoms Scale (NMSS), mini-mental state examination (MMSE), Parkinson disease sleep scales (PDSS), Rapid Eye Movement Sleep Behaviour Disorder Questionnaire(RBDQ-HK), Epworth Sleepiness Scale (ESS), Rome III functional constipation scale, the Scale for Outcomes in PD for Autonomic Symptoms (SCOPA-AUT), Parkinson Fatigue Scale (PFS), Cambridge-Hopkins Restless Legs Syndrome questionnaire (CHRLSq), Hyposmia rating scale(HRS), Hamilton depression scale, the 39-item Parkinson's Disease Questionnaire(PDQ-39), Freezing of gait scale(FOG), dyskinesia related scales, Wearing-off scale(WO).
- The investigators will also exam the blood biomarkers of PD such as uric acid and peripheral inflammatory markers.
| Study Type : | Observational |
| Estimated Enrollment : | 1000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | The Chinese Parkinson's Disease With LRRK2 Variants Registry |
| Actual Study Start Date : | February 1, 2017 |
| Estimated Primary Completion Date : | February 1, 2027 |
| Estimated Study Completion Date : | February 1, 2027 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Parkinson disease
MedlinePlus related topics:
Parkinson's Disease
Primary Outcome Measures :
- Database of Parkinson's disease with LRRK2 variants [ Time Frame: 10 years ]Establish the database of Parkinson's disease with LRRK2 variants in mainland China.
- Clinical feature [ Time Frame: 10 years ]Characterize the clinical feature in patients of Parkinson's disease with LRRK2 variants
Biospecimen Retention: Samples With DNA
extraction of DNA from peripheral blood
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
PD patients with LRRK2 variants
Criteria
Inclusion Criteria:
- Patients diagnosed with PD by the United Kingdom Parkinson's Disease Society Brain Bank clinical diagnostic criteria or other standard criteria; PD patients detected with positive LRRK2 variants
Exclusion Criteria:
-
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523104
Contacts
| Contact: Jifeng Guo, Ph.D. | +8613974936815 | guojifeng2003@163.com | |
| Contact: Beisha Tang, Ph.D. | +8613974856709 | bstang7398@163.com |
Locations
| China, Hunan | |
| Xiangya Hospital of Central South University | Recruiting |
| Changsha, Hunan, China, 410008 | |
| Contact: Jifeng Guo, Ph.D. +8613974936815 guojifeng2003@163.com | |
| Contact: Qiying Sun, Ph.D. +8615874907260 sunqiying2015@163.com | |
Sponsors and Collaborators
Xiangya Hospital of Central South University
Publications of Results:
| Responsible Party: | Xiangya Hospital of Central South University |
| ClinicalTrials.gov Identifier: | NCT03523104 |
| Other Study ID Numbers: |
CPD-LRRK2R |
| First Posted: | May 14, 2018 Key Record Dates |
| Last Update Posted: | May 29, 2018 |
| Last Verified: | April 2018 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |