Chinese FPD Registry

Recruiting

• Conditions: Parkinson Disease

• Registration Number: NCT03508986
• Lead Sponsor: Xiangya Hospital of Central South University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2017-02-01
• Status Verified: 2018-04
• Study First Submitted: 2018-04-11
• Study First Submitted QC: 2018-04-24
• Study First Posted: 2018-04-26
• Last Update Submitted: 2018-05-03
• Last Update Posted: 2018-05-11
• Primary Completion: 2027-02-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China