Chinese FPD Registry

Parkinson Disease Clinical Trial

Official title:

The Chinese Familial Parkinson's Disease Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03508986
• Other study ID #: CFPDR
• Status: Recruiting
• Start date: February 1, 2017
• Est. completion date: February 1, 2027

Study information

• Verified date: April 2018
• Source: Xiangya Hospital of Central South University
• Contact: Jifeng Guo, Ph.D.
• Phone: +8613974936815
• Email: guojifeng2003[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of the Chinese Familial Parkinson's disease Registry (CFPDR) is to develop a database of patients with familial Parkinson's disease (PD) in China.

Description:

Parkinson's disease (PD) is the second most common disorder among degenerative neurological disease. Familial PD (FPD) has its unique clinical feature and genetic basis. We aim to establish a database of FPD,and characterize the clinical feature, genetic basis, environmental factors and their interactions FPD in China.

Method:

1. Clinical feature will be measured by scales and neurological tests.Standard scales includes: Unified Parkinson's Disease Rating Scale(UPDRS), Hoehn-Yahr stages, NMSS, MMSE, PDSS(Parkinson disease sleep scales),Rapid Eye Movement Sleep Behaviour Disorder Questionnaire(RBDQ-HK),ESS(Epworth Sleepiness Scale),Rome III functional constipation scale，SCOPA-AUT (the Scale for Outcomes in PD for Autonomic Symptoms)，PFS(Parkinson Fatigue Scale)，CH-RLSq，Hyposmia rating scale(HRS)HAMILT depression scale，the 39-item Parkinson's Disease Questionnaire(PDQ-39)，Freezing of gait scale(FOG)，dyskinesia related scales, Wearing-off scale(WO)

2. Peripheral blood from patients and other members in family will be collected for familial PD genetic testing.

3. The environmental factors are exploded by questionnaires including smoking,drinking, pesticide and heavy metals.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: February 1, 2027
• Est. primary completion date: February 1, 2027
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Parkinson's disease, and either family history of Parkinson's disease (first or second degree family member affected by Parkinson's disease) AND/OR Clinical diagnosis of Parkinson's disease and their parents are close relatives(First or second degree family member of an Index Case, affected or unaffected by Parkinson's disease).

Exclusion Criteria:

• Lack of capacity to consent to participate in the project

Related Conditions & MeSH terms

• Parkinson Disease

Locations

Country	Name	City	State
China	Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

References & Publications (5)

Guo JF, Li K, Yu RL, Sun QY, Wang L, Yao LY, Hu YC, Lv ZY, Luo LZ, Shen L, Jiang H, Yan XX, Pan Q, Xia K, Tang BS. Polygenic determinants of Parkinson's disease in a Chinese population. Neurobiol Aging. 2015 Apr;36(4):1765.e1-1765.e6. doi: 10.1016/j.neuro — View Citation

Li K, Tang BS, Liu ZH, Kang JF, Zhang Y, Shen L, Li N, Yan XX, Xia K, Guo JF. LRRK2 A419V variant is a risk factor for Parkinson's disease in Asian population. Neurobiol Aging. 2015 Oct;36(10):2908.e11-5. doi: 10.1016/j.neurobiolaging.2015.07.012. Epub 2015 Jul 11. — View Citation

Liu Z, Guo J, Li K, Qin L, Kang J, Shu L, Zhang Y, Wei Y, Yang N, Luo Y, Sun Q, Xu Q, Yan X, Tang B. Mutation analysis of CHCHD2 gene in Chinese familial Parkinson's disease. Neurobiol Aging. 2015 Nov;36(11):3117.e7-3117.e8. doi: 10.1016/j.neurobiolaging. — View Citation

Yan W, Tang B, Zhou X, Lei L, Li K, Sun Q, Xu Q, Yan X, Guo J, Liu Z. TMEM230 mutation analysis in Parkinson's disease in a Chinese population. Neurobiol Aging. 2017 Jan;49:219.e1-219.e3. doi: 10.1016/j.neurobiolaging.2016.10.007. Epub 2016 Oct 11. — View Citation

Yang Y, Tang BS, Weng L, Li N, Shen L, Wang J, Zuo CT, Yan XX, Xia K, Guo JF. Genetic Identification Is Critical for the Diagnosis of Parkinsonism: A Chinese Pedigree with Early Onset of Parkinsonism. PLoS One. 2015 Aug 21;10(8):e0136245. doi: 10.1371/journal.pone.0136245. eCollection 2015. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Database of Familial Parkinson's disease	To collect 1500 patients with familial Parkinson's disease and establish the database of Familial Parkinson's disease (FPD) in mainland China.	10 years
Primary	Risk Factors	To characterize clinical feature and environmental factors among Chinese familial parkinson's disease	10 years
Primary	Genetic Basis	To characterize the genetic basis of Chinese FPD and detect clinically relevant genetic variants in these cases	10 years