Parkinson's Disease Genetics Database

Parkinson's Disease Clinical Trial

Official title:

Parkinson's Disease Genetics Database

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00855556
• Other study ID #: GCRC 0171
• Status: Terminated
• Phase: N/A
• First received: February 25, 2009
• Last updated: September 15, 2015
• Start date: February 2008
• Est. completion date: February 2013

Study information

• Verified date: September 2015
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The goal of the study is to develop and organize an effort to identify genes that determine an individual's risk for developing Parkinson's disease (PD).

1. To ascertain, study and establish a repository of DNA samples that will allow for the identification of known and yet-to-be-identified genetic markers associated with the development of PD.

2. To create a database with clinical, genetic (HLA, genome screen) and medical history information that will facilitate the search for PD susceptibility genes.

3. To provide a centralized DNA repository to allow for targeted studies of genetic factors contributing to the onset, heterogeneity and progression of PD.

4. To evaluate opportunities to extend the results of research to develop methods of risk prediction, prevention and therapy for PD.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subjects must have a diagnosis of Parkinson's Disease as determined by standard neurological criteria.

• Patients =18 years of age who are able to provide informed consent

• Patients = 18 who are decisionally impaired for whom informed consent can be obtained by a legally authorized representative.

Exclusion Criteria:

• Patients without a diagnosis of Parkinson's Disease.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Genetic:
• blood draw
The blood collection is designed to obtain blood samples as a source of DNA for genotyping and to establish a plasma and serum storage repository for future assays. GCRC nurses will perform all blood draws associated with this study. The following procedures are designed to standardize sample collection: Blood will be collected with the participant in the seated position with the reclining position reserved for those with a history of fainting during blood collection. Participants will be instructed to drink plenty of water (e.g., at least 8 large glasses of water) prior to the clinic visit as this facilitates easier collection. No fasting, activity or medication restrictions are required prior to or following blood collection. Blood collection will follow completion of the questionnaires. They will be performed by a nurse or technician with documented class time and experience in phlebotomy. Technician certification will occur prior to blood collection.

Locations

Country	Name	City	State
United States	The Feinstein Institute for Medical Research	Manhasset	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the current protocol is for establishment of the registry only and not for particular analyses of its contents		5 years	No