NCT00855556

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 4, 2009

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

September 16, 2015

Status Verified

September 1, 2015

Enrollment Period

5 years

First QC Date

February 25, 2009

Last Update Submit

September 15, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • the current protocol is for establishment of the registry only and not for particular analyses of its contents

    5 years

Interventions

blood drawGENETIC

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: 1. 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. 2. 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. 3. No fasting, activity or medication restrictions are required prior to or following blood collection. 4. 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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects with a diagnosis of Parkinson's Disease as determined by standard neurological criteria.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients without a diagnosis of Parkinson's Disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Feinstein Institute for Medical Research

Manhasset, New York, 11030, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA stored in TE buffer solution

MeSH Terms

Conditions

Parkinson Disease

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Michael Pourfar, MD

    Northwell Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 25, 2009

First Posted

March 4, 2009

Study Start

February 1, 2008

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

September 16, 2015

Record last verified: 2015-09

Locations