PROGENI (Parkinson's Research: The Organized Genetics Initiative) Family Study of LRRK2 (Leucine-rich Repeat Kinase 2)

Parkinson Disease Clinical Trial

— PROGENI  

Official title:

PROGENI (Parkinson's Research: The Organized Genetics Initiative) Family Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01536821
• Other study ID #: 1105005340
• Status: Completed
• Phase: N/A
• First received: February 16, 2012
• Last updated: December 13, 2013
• Start date: May 2011
• Est. completion date: December 2013

Study information

• Verified date: April 2013
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The PROGENI Family Study is part of a larger consortium that is studying a gene shown to be important in Parkinson's disease, called LRRK2. People who have a defect in the LRRK2 gene will often develop Parkinson's disease. Eligible participants will be asked to complete a single Study Visit at an affiliated research facility closest to their home.

Description:

Participants will be asked to complete a family history questionnaire, which will gather information about their family history of Parkinson's disease and related disorders. They will be asked to complete a single Study Visit, during which they will be asked to do some or all of the following:

1. Complete questionnaires regarding Parkinson's disease symptoms, medical history, mood, sleep, mental status, and activity level.

2. Be given a brief standard neurological examination.

3. Be given a scratch and sniff smell identification test.

4. Be asked to give a sample of approximately 2 tablespoons of blood.

5. Be asked to give a urine sample of approximately 1 tablespoon of urine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Positive for a LRRK2 mutation

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson Disease

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	Indiana University Medical Center	Indianapolis	Indiana
United States	University of Iowa Hospitals	Iowa City	Iowa
United States	Kansas University Medical Center	Kansas City	Kansas
United States	Beth Israel Medical Center	New York	New York
United States	University of Nebraska	Omaha	Nebraska
United States	Oregon Health & Science University	Portland	Oregon
United States	Medical University of Ohio	Toledo	Ohio
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Michael J. Fox Foundation for Parkinson's Research

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observation and biological specimen collection		1 time	No

External Links

•   PROGENI Study website