Parkinson's Foundation PD GENEration Genetic Registry | NCT04994015

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 20, 2020Actual

Primary Completion Date

Jun 30, 2026Estimated

Completion Date

Jul 1, 2026Estimated

First Submitted Date

Jul 29, 2021

First Submission Date that Met QC Criteria

Jul 29, 2021

First Posted Date

Aug 6, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2025

Last Update Posted Date

May 21, 2025Actual

Name	Class
Indiana University	OTHER
Fulgent Genetics	UNKNOWN
The Parkinson Study Group	NETWORK

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Development of a central repository for PD-related genomic data for future research.

Detailed Description

The purpose of this study is to develop a central repository for PD-related genomic data by individuals who consent to deposit their data and bank their residual DNA obtained through clinical genetic testing for future research use.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

30 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

25,000Estimated

Name	Type	Description	Arm Group Labels	Other Names
Lab Assay for seven genetic variants for Parkinson's Disease	Device	Counseling provided to participant by site clinician/physician/genetic counselor.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of Parkinson's related genetic mutations in an convenience cohort	Identify people with Parkinson's who have genetic mutations to advance basic science and clinical research.	6 months
Educating people with Parkinson's of their genetic mutation status through genetic testing and counseling	People who are informed of their genetic status may be empowered to learn more about their disease and participant in clinical research.	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Study Population 1: PWP (open for recruitment)
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 GBA, LRRK2 and 5 additional PD related genes (SNCA, VPS35, PRKN, PINK-1, PARK7).
3. Capacity to give full informed consent in writing or electronically, and have read and signed the informed consent forms (ICFs) based on site clinician's determination.
4. Able to perform study activities (including completion of either online, in-person or paper surveys).

Study Population 2: People at risk of developing PD (not open for recruitment)

1. Family members of Study Population 1 may be invited to participate in the study if confirmatory genetic testing is deemed necessary by the genetic testing laboratory.

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.
Under the age of 18

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Any person with probable diagnosis of Parkinson's disease according to the Movement Disorders Society criteria.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kamalini Ghosh, MS	Contact	1-800-473-4636		kghosh@parkinson.org

Overall Officials

Name	Affiliation	Role
James Beck, PhD	Parkinson's Foundation	Principal Investigator
Roy N Alcalay, MS, MD	Tel Aviv Sourasky Medical Center, Columbia University Irving Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama Birmingham	Recruiting	Birmingham	Alabama	35294	United States

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D009069	Movement Disorders
D000080874	Synucleinopathies
D019636	Neurodegenerative Diseases