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PDGeneration: Mapping the Future of Parkinson's Disease (PDGENE)

Primary Purpose

Parkinson's Disease and Parkinsonism

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lab Assay for seven genetic variants for Parkinson's Disease
Lab Assay for seven genetic variants for Parkinson's Disease
Sponsored by
Parkinson's Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Parkinson's Disease and Parkinsonism focused on measuring Parkinson's, Genetics, PD Genetics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Meet Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease: probable diagnosis.
  2. Willingness to undergo genetic testing, and choose to be informed of genetic testing results for Glucosylceramidase Beta (GBA), LRRK2 and 5 additional PD related genes (SNCA, VPS35, PRKN, PINK-1, PARK7).
  3. Capacity to give full informed consent in writing, and have read and signed the informed consent forms (ICFs) based on clinician's determination.
  4. Able to perform study activities (including completion of either online, in-person or paper surveys).
  5. Individuals must speak and understand the language of the informed consent.

Exclusion Criteria:

  1. Diagnosis of an atypical parkinsonian disorder (i.e., multiple system atrophy, progressive supranuclear palsy, dementia with Lewy bodies, corticobasal syndrome), including that due to medications, metabolic disorders, encephalitis, cerebrovascular disease, or normal pressure hydrocephalus.
  2. Individuals who have received a blood transfusion within the past 3 months.
  3. Individuals who have active hematologic malignancies such as lymphoma or leukemia.
  4. Individuals who have had a bone marrow transplant within the past 5 years.

Sites / Locations

  • Barrow Neurological Institute
  • University of California San Diego (UCSD)
  • University of Miami
  • Cleveland Clinic Florida-Weston
  • Northwestern University Feinberg School of Medicine
  • University of Kansas Medical Center
  • Massachusetts General Hospital
  • Health Partners/Park Nicollet: Struthers Parkinson's Center
  • Beth Israel Medical Center
  • Columbia University
  • Cleveland Clinic
  • University of Pennsylvania
  • Baylor College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Site-Based Genetic Counseling

Centralized Genetic Counseling

Arm Description

Participants randomized to this arm will receive genetic counseling for genetic results through the enrolling site.

Participants randomized to this arm will receive genetic counseling for genetic results through a centralized genetic counseling group at Indiana University.

Outcomes

Primary Outcome Measures

Feasibility of genetic testing and counseling
The total number of participants who receive genetic testing and counseling.
Impact Evaluation
The impact of knowledge gained by people with Parkinson's by assessing returned survey responses regarding their behavior and follow-up to clinical care after receipt of genetic counseling.
Satisfaction Comparison
Differences in satisfaction of receiving genetic test results and genetic counseling by enrolling site (clinician/genetic counselor) or centralized counseling group using the Clinical Genetic Counseling Satisfaction Score.

Secondary Outcome Measures

Number of participants that enroll in precision medicine trials
Number of participants that enroll in precision medicine trials
Time it takes between first contact to the return of genetic test results
Number of weeks it takes between participant consent to return of genetic test results.

Full Information

First Posted
August 6, 2019
Last Updated
July 12, 2023
Sponsor
Parkinson's Foundation
Collaborators
Fulgent Laboratories, Indiana University, The Parkinson Study Group, Navitas Clinical Research, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT04057794
Brief Title
PDGeneration: Mapping the Future of Parkinson's Disease
Acronym
PDGENE
Official Title
Parkinson's Foundation: PD Generation: Mapping the Future of Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 15, 2019 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
April 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Parkinson's Foundation
Collaborators
Fulgent Laboratories, Indiana University, The Parkinson Study Group, Navitas Clinical Research, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To assess the feasibility, impact, and participant satisfaction of offering Clinical Laboratory Improvement Amendments (CLIA) certified genetic testing as part of clinical care for People with Parkinson's disease (PWP).
Detailed Description
The purpose of this study is to evaluate how offering Clinical Laboratory Improvement Amendments (CLIA) certified genetic testing for Parkinson's Disease (PD) genes to people with Parkinson's Disease impacts clinical care and potential enrollment in clinical trials. This multi-center study will assess the impact and satisfaction of the mode of genetic counseling by comparing counseling conducted by a clinician versus centralized genetic counseling conducted through Indiana University. The study will also assess knowledge gained by administering a knowledge survey pre- and post-genetic testing. All genetic test results will be returned to participants through a genetic counseling visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease and Parkinsonism
Keywords
Parkinson's, Genetics, PD Genetics

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will undergo genetic counseling service post-genetic testing either locally or through central services.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1982 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Site-Based Genetic Counseling
Arm Type
Active Comparator
Arm Description
Participants randomized to this arm will receive genetic counseling for genetic results through the enrolling site.
Arm Title
Centralized Genetic Counseling
Arm Type
Active Comparator
Arm Description
Participants randomized to this arm will receive genetic counseling for genetic results through a centralized genetic counseling group at Indiana University.
Intervention Type
Device
Intervention Name(s)
Lab Assay for seven genetic variants for Parkinson's Disease
Intervention Description
Counseling provided to participant by site clinician/physician/genetic counselor.
Intervention Type
Device
Intervention Name(s)
Lab Assay for seven genetic variants for Parkinson's Disease
Intervention Description
Counseling provided to participant by centralized genetic counseling group at Indiana University.
Primary Outcome Measure Information:
Title
Feasibility of genetic testing and counseling
Description
The total number of participants who receive genetic testing and counseling.
Time Frame
up to 24 weeks
Title
Impact Evaluation
Description
The impact of knowledge gained by people with Parkinson's by assessing returned survey responses regarding their behavior and follow-up to clinical care after receipt of genetic counseling.
Time Frame
up to 6 months
Title
Satisfaction Comparison
Description
Differences in satisfaction of receiving genetic test results and genetic counseling by enrolling site (clinician/genetic counselor) or centralized counseling group using the Clinical Genetic Counseling Satisfaction Score.
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Number of participants that enroll in precision medicine trials
Description
Number of participants that enroll in precision medicine trials
Time Frame
up to 12 months
Title
Time it takes between first contact to the return of genetic test results
Description
Number of weeks it takes between participant consent to return of genetic test results.
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meet Movement Disorder Society (MDS) Clinical Diagnostic Criteria for Parkinson's Disease: probable diagnosis. Willingness to undergo genetic testing, and choose to be informed of genetic testing results for Glucosylceramidase Beta (GBA), LRRK2 and 5 additional PD related genes (SNCA, VPS35, PRKN, PINK-1, PARK7). Capacity to give full informed consent in writing, and have read and signed the informed consent forms (ICFs) based on clinician's determination. Able to perform study activities (including completion of either online, in-person or paper surveys). Individuals must speak and understand the language of the informed consent. Exclusion Criteria: Diagnosis of an atypical parkinsonian disorder (i.e., multiple system atrophy, progressive supranuclear palsy, dementia with Lewy bodies, corticobasal syndrome), including that due to medications, metabolic disorders, encephalitis, cerebrovascular disease, or normal pressure hydrocephalus. Individuals who have received a blood transfusion within the past 3 months. Individuals who have active hematologic malignancies such as lymphoma or leukemia. Individuals who have had a bone marrow transplant within the past 5 years.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy N Alcalay, MD, MS
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barrow Neurological Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
University of California San Diego (UCSD)
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
University of Miami
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Cleveland Clinic Florida-Weston
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Facility Name
Health Partners/Park Nicollet: Struthers Parkinson's Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55427
Country
United States
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.parkinson.org/PDGENEration
Description
For more information and to enroll, please visit the website.

Learn more about this trial

PDGeneration: Mapping the Future of Parkinson's Disease

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