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

This study has been completed.
Sponsor:
Collaborator:
Michael J. Fox Foundation for Parkinson's Research
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01536821
First received: February 16, 2012
Last updated: December 13, 2013
Last verified: April 2013

February 16, 2012
December 13, 2013
May 2011
December 2013   (final data collection date for primary outcome measure)
Observation and biological specimen collection [ Time Frame: 1 time ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01536821 on ClinicalTrials.gov Archive Site
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PROGENI (Parkinson's Research: The Organized Genetics Initiative) Family Study of LRRK2 (Leucine-rich Repeat Kinase 2)
PROGENI (Parkinson's Research: The Organized Genetics Initiative) Family Study

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.

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.
Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

DNA, plasma and serum will be obtained and stored from a blood sample. In addition, a whole blood and urine samples will be obtained and stored.

Non-Probability Sample

Participants must provide test results documenting a LRRK2 mutation.

Parkinson Disease
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
81
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

Positive for a LRRK2 mutation

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01536821
1105005340
Yes
Indiana University
Indiana University
Michael J. Fox Foundation for Parkinson's Research
Principal Investigator: Tatiana Foroud, PhD Indiana University
Indiana University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP