Completed
PROGENI

Parkinson's Research: The Organized Genetics Initiative

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What is being collected

Data Collection

Collected from today forward - Prospective
DNA Samples
Who is being recruted

Parkinson Disease

+2 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: August 1998

See protocol details

Summary

Principal SponsorIndiana University School of Medicine
Last updated: February 16, 2011
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 1998Actual date on which the first participant was enrolled.

The purpose of this trial is to study genetic and other risk factors that may be important in the development of Parkinson's disease. The The Parkinson's Research: The Organized Genetics Initiative, also known as PROGENI, is a multi-center study involving 2000 people throughout North America who are affected, or possibly affected, with Parkinson's disease (PD). The goal of the initiative is to study the genetic and other risk factors which may be important in the development of PD. In order to better understand the genetic factors leading to PD, researchers will study families having 2 or more members diagnosed with PD. Using DNA samples from each participant, researchers hope to identify genes that may cause a person to be at higher risk for developing PD. Each participant in the study will be asked to complete a family history questionnaire, providing information about the history of PD in the family. Participants also will be asked to discuss the symptoms they have experienced and their responses to PD medications. This information will be used by study personnel to determine further eligibility for the study. Those eligible for further participation will be asked to undergo a study visit at the site closest to their residence, during which they will be asked to complete questionnaires regarding PD symptoms, medical history, places of residence, occupations, mood, mental status, and activity level. A blood sample will be drawn for DNA extraction. The study visit will take about 2 hours.

Official TitleParkinson's Disease Collaborative Study of Genetic Linkage 
Principal SponsorIndiana University School of Medicine
Last updated: February 16, 2011
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
1800 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Cohort
These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

What happens to patients' samples
Samples from participants are kept, and they can be used to extract DNA in the future. These might include things like blood or frozen tissue. This allows researchers to study genetics and how DNA may relate to the disease.

Other Options for Sample Use
Samples Without DNA: Samples are kept but not usable for DNA analysis.
None Retained: No samples are kept after the study.

How participants are selected
Participants are selected without using randomization. They may be chosen based on convenience, access, or willingness to participate. This approach is common when random selection isn’t practical.
Another way to select participants is through a probability sample, where participants are chosen randomly, so everyone has an equal chance to be included.

How information is collected
Researchers start collecting data from the present day forward, following participants over time to observe outcomes. This approach helps identify how exposures or behaviors may lead to health events in the future.Other Ways to Collect Data
Retrospective: These studies use existing medical records or past data.
Cross-sectional: These studies collect data at one single point in time.
Others: Some studies use a mix of approaches or less common designs depending on the research goal.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Parkinson Disease
Criteria
1 inclusion criteria required to participate
To be eligible to participate in this study participants must be diagnosed with or have symptoms of PD. In addition, they must also have a family history of PD in other relatives
1 exclusion criteria prevent from participating
Subjects cannot have participated in any other genetic research project for Parkinson's disease

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 58 locations
Suspended
Barrow Neurological InstitutePhoenix, United StatesSee the location
Suspended
Parkinson's & Movement Disorder InstituteFountain Valley, United States
Suspended
University of California IrvineIrvine, United States
Suspended
Pacific Neuroscience Medical Group, IncOxnard, United States
Completed58 Study Centers