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Genetic Testing for Parkinson's Disease (PDGENE Trial)
N/A
Waitlist Available
Led By Roy N Alcalay, MD, MS
Research Sponsored by Parkinson's Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Capacity to give full informed consent in writing, and have read and signed the informed consent forms (ICFs) based on clinician's determination
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
PDGENE Trial Summary
This trial will test how well a genetic testing program works when offered to people with Parkinson's disease.
Who is the study for?
This trial is for people with a probable diagnosis of Parkinson's Disease who can consent to the study, complete surveys, and are willing to undergo genetic testing. They must understand the language of the informed consent. Those with blood cancers, recent bone marrow transplants or blood transfusions, or atypical parkinsonian disorders cannot participate.Check my eligibility
What is being tested?
The trial is offering certified genetic testing for seven specific gene variants linked to Parkinson's Disease as part of clinical care. It aims to evaluate how feasible and satisfying this process is for participants.See study design
What are the potential side effects?
Since this trial involves only genetic testing without any drugs or medical procedures, there are no direct physical side effects expected from participating in this study.
PDGENE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I understand the study details and have signed the consent forms.
PDGENE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of genetic testing and counseling
Impact Evaluation
Satisfaction Comparison
Secondary outcome measures
Number of participants that enroll in precision medicine trials
Time it takes between first contact to the return of genetic test results
PDGENE Trial Design
2Treatment groups
Active Control
Group I: Site-Based Genetic CounselingActive Control1 Intervention
Participants randomized to this arm will receive genetic counseling for genetic results through the enrolling site.
Group II: Centralized Genetic CounselingActive Control1 Intervention
Participants randomized to this arm will receive genetic counseling for genetic results through a centralized genetic counseling group at Indiana University.
Find a Location
Who is running the clinical trial?
University of Rochester - CHeT/CTCCUNKNOWN
Parkinson's FoundationLead Sponsor
11 Previous Clinical Trials
1,018,902 Total Patients Enrolled
Fulgent LaboratoriesUNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I can complete study tasks, whether online, in-person, or on paper.I understand the study details and have signed the consent forms.I have been diagnosed with a rare form of Parkinson's disease.I have received a blood transfusion in the last 3 months.I have an active blood cancer like lymphoma or leukemia.I had a bone marrow transplant within the last 5 years.I agree to genetic testing for Parkinson's disease and want to know the results.
Research Study Groups:
This trial has the following groups:- Group 1: Site-Based Genetic Counseling
- Group 2: Centralized Genetic Counseling
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what extent is participation in this trial being solicited?
"As many as 15000 patients that meet the pre-defined eligibility requirements are being recruited for this medical trial. Participants can choose between Columbia University in New york City, and Massachusetts General Hospital in Boston to take part."
Answered by AI
Are new participants presently signing up for this clinical experiment?
"As verified through an examination of clinicaltrials.gov, this medical study is presently seeking participants and has been accepting applicants since its posting on August 15th 2019 with the most recent update occurring on March 8th 2021."
Answered by AI
In what locations can this research be conducted?
"Currently, 13 medical centres are participating in this trial; these locations span from New york to Boston and extend to Fort Lauderdale. To minimise travel requirements, it is suggested that patients choose the site closest to them when signing up for the study."
Answered by AI
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