PROGENI Family Study of LRRK2
This study is currently recruiting participants.
Verified April 2013 by Indiana University
Sponsor:
Indiana University
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: April 2, 2013
Last verified: April 2013
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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 Family Study |
Resource links provided by NLM:
Further study details as provided by Indiana University:
Biospecimen Retention: Samples With DNA
Detailed 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.
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
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:
- Complete questionnaires regarding Parkinson's disease symptoms, medical history, mood, sleep, mental status, and activity level.
- Be given a brief standard neurological examination.
- Be given a scratch and sniff smell identification test.
- Be asked to give a sample of approximately 2 tablespoons of blood.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01536821
Contacts
| Contact: Cheryl A Halter, MS, CCRC | 888-830-6299 | progeni@iupui.edu |
Locations
| United States, Florida | |
| Cleveland Clinic Florida | Recruiting |
| Weston, Florida, United States, 33331 | |
| Contact: Cheryl A Halter, MS, CCRC 888-830-6299 progeni@iupui.edu | |
| United States, Indiana | |
| Indiana University Medical Center | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Cheryl A Halter, MS, CCRC 888-830-6299 progeni@iupui.edu | |
| United States, Iowa | |
| University of Iowa Hospitals | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Cheryl A Halter, MS, CCRC 888-830-6299 progeni@iupui.edu | |
| United States, Kansas | |
| Kansas University Medical Center | Recruiting |
| Kansas City, Kansas, United States, 66160 | |
| Contact: Cheryl A Halter, MS, CCRC 888-830-6299 progeni@iupui.edu | |
| United States, Maryland | |
| University of Maryland School of Medicine | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Cheryl A Halter, MS, CCRC 888-830-6299 progeni@iupui.edu | |
| Principal Investigator: William J Weiner, MD | |
| United States, Nebraska | |
| University of Nebraska | Recruiting |
| Omaha, Nebraska, United States, 68198 | |
| Contact: Cheryl A Halter, MS, CCRC 888-830-6299 progeni@iupui.edu | |
| United States, New York | |
| Beth Israel Medical Center | Recruiting |
| New York, New York, United States, 10003 | |
| Contact: Cheryl A Halter, MS, CCRC 888-830-6299 progeni@iupui.edu | |
| United States, Ohio | |
| Medical University of Ohio | Recruiting |
| Toledo, Ohio, United States, 43614 | |
| Contact: Cheryl A Halter, MS, CCRC 888-830-6299 progeni@iupui.edu | |
| United States, Oregon | |
| Oregon Health & Science University | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Cheryl A Halter, MS< CCRC 888-830-6299 progeni@iupui.edu | |
| Canada, Alberta | |
| University of Alberta | Recruiting |
| Edmonton, Alberta, Canada, T5G 0B7 | |
| Contact: Cheryl A Halter, MS, CCRC 888-830-6299 progeni@iupui.edu | |
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: | April 2, 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 Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on May 23, 2013