PDGeneration: Mapping the Future of Parkinson's Disease

NCT04057794 | Unknown FDA Device

• 1 other identifier: PDGene-01
• Study Type: interventional
• Target: 1,982
• Locations: 1 country
• Sites: 13

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).

Conditions

Parkinson's Disease and Parkinsonism

Keywords

Parkinson's; Genetics; PD Genetics

Outcome Measures

Primary Outcomes (3)

• Feasibility of genetic testing and counseling

  The total number of participants who receive genetic testing and counseling.

  up to 24 weeks

• 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.

  up to 6 months

• 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.

  up to 6 months

Secondary Outcomes (2)

• Number of participants that enroll in precision medicine trials

  up to 12 months

• Time it takes between first contact to the return of genetic test results

  up to 12 months

Study Arms (2)

Site-Based Genetic Counseling

ACTIVE COMPARATOR

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

Device: Lab Assay for seven genetic variants for Parkinson's Disease

Centralized Genetic Counseling

ACTIVE COMPARATOR

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

Device: Lab Assay for seven genetic variants for Parkinson's Disease

Interventions

Lab Assay for seven genetic variants for Parkinson's Disease DEVICE

Counseling provided to participant by site clinician/physician/genetic counselor.

Site-Based Genetic Counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Parkinson's Foundation: lead
• Fulgent Laboratories: collaborator
• Indiana University: collaborator
• The Parkinson Study Group: collaborator
• Navitas Clinical Research, Inc: collaborator

Study Sites (13)

Barrow Neurological Institute

Phoenix, Arizona, 85013, United States

Location

University of California San Diego (UCSD)

La Jolla, California, 92093, United States

Location

University of Miami

Fort Lauderdale, Florida, 33308, United States

Location

Cleveland Clinic Florida-Weston

Weston, Florida, 33331, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02129, United States

Location

Health Partners/Park Nicollet: Struthers Parkinson's Center

Minneapolis, Minnesota, 55427, United States

Location

Beth Israel Medical Center

New York, New York, 10003, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19107, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Links

• For more information and to enroll, please visit the website.

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Roy N Alcalay, MD, MS

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will undergo genetic counseling service post-genetic testing either locally or through central services.

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 15, 2019
• Study Start: August 15, 2019
• Primary Completion: December 1, 2021
• Study Completion: April 15, 2025
• Last Updated: July 14, 2023

Record last verified: 2023-07

Locations

US (13)