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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
  Purpose

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.


Condition
Parkinson Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: PROGENI (Parkinson's Research: The Organized Genetics Initiative) Family Study

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Observation and biological specimen collection [ Time Frame: 1 time ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

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.


Enrollment: 81
Study Start Date: May 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants must provide test results documenting a LRRK2 mutation.

Criteria

Inclusion Criteria:

Positive for a LRRK2 mutation

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01536821

Locations
United States, Florida
Cleveland Clinic Florida
Weston, Florida, United States, 33331
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa Hospitals
Iowa City, Iowa, United States, 52242
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
United States, Maryland
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
United States, Nebraska
University of Nebraska
Omaha, Nebraska, United States, 68198
United States, New York
Beth Israel Medical Center
New York, New York, United States, 10003
United States, Ohio
Medical University of Ohio
Toledo, Ohio, United States, 43614
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T5G 0B7
Sponsors and Collaborators
Indiana University
Michael J. Fox Foundation for Parkinson's Research
Investigators
Principal Investigator: Tatiana Foroud, PhD Indiana University
  More Information

Additional Information:
No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01536821     History of Changes
Other Study ID Numbers: 1105005340
Study First Received: February 16, 2012
Last Updated: December 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
Parkinson disease
Parkinson's Disease
PD
LRRK2
genetics
genes

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on November 20, 2014