NCT01536821

Brief 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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2011

Typical duration for all trials

Geographic Reach
2 countries

10 active sites

Status
completed

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

May 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 22, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 16, 2013

Status Verified

April 1, 2013

Enrollment Period

2.6 years

First QC Date

February 16, 2012

Last Update Submit

December 13, 2013

Conditions

Parkinson Disease

Keywords

Parkinson diseaseParkinson's DiseasePDLRRK2geneticsgenes

Outcome Measures

Primary Outcomes (1)

  • Observation and biological specimen collection

    1 time

Eligibility Criteria

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

Participants must provide test results documenting a LRRK2 mutation.

You may qualify if:

  • Positive for a LRRK2 mutation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Indiana University Medical Center

Indianapolis, Indiana, 46202, United States

Location

University of Iowa Hospitals

Iowa City, Iowa, 52242, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

University of Nebraska

Omaha, Nebraska, 68198, United States

Location

Beth Israel Medical Center

New York, New York, 10003, United States

Location

Medical University of Ohio

Toledo, Ohio, 43614, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

University of Alberta

Edmonton, Alberta, T5G 0B7, Canada

Location

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.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Tatiana Foroud, PhD

    Indiana University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2012

First Posted

February 22, 2012

Study Start

May 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

December 16, 2013

Record last verified: 2013-04

Locations

CA(1)US(9)