Parkinson's Progression Markers Initiative 2.0 Remote Study

TF

Tatiana Foroud

Principal Investigator

Status: Enrolling By Invitation Ages: 30 Years - 100 Years Gender: All Genders Phase: N/A 1 Locations

Brief Description

The purpose of PPMI 2.0 Remote is to find out if information collected remotely (by internet, mail, home visits, or phone applications) can help identify individuals at an increased risk of developing Parkinson’s Disease.  Identifying at-risk individuals may also help researchers learn how to better develop and test new interventions intended to delay or prevent disease progression in the early stages of PD. 
 
To accomplish this, the specific aims of the study are: 
a) Establish a comprehensive recruitment strategy targeting individuals likely to be at increased risk of PD. 
b) Develop a risk paradigm to determine criteria for study participants to be selected for dopamine transporter single photon emission computed tomography (SPECT) imaging 
c) Refine the risk paradigm based on accruing data collected in PPMI initiatives combined with imaging, clinical, and biomarker information collected in the PPMI Clinical study.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - Subjects will be identified through a number of mechanisms. Initially subjects are recruited through targeted outreach for increased risk for PD by the Michael J. Fox Foundation (sponsor) as well as PPMI clinical sites. These individuals are pushed to WRD (IRB 1703921430), where subjects will be identified as those who have completed genetic screening through the existing WRD study or reported other risk factors for PD, such as a family history of PD. These individuals will be invited to enroll in the PPMI Remote Data Collection study by WRD study staff or through website communication and/or email.

Detailed Description

If the eligible subject agrees to participate in the Clinical study, IU will refer the participant to a PPMI Clinical site to be enrolled in the PPMI Clinical Protocol.  Subjects will access the participant portal (a customized secure website created for this study) using chosen login details. Through the portal, they will complete consent as well as screening questionnaires (demographics, smoking history, travel preferences, etc.). 
  • Questionnaires should take 5-10 minutes to complete. Applicable questionnaires will be visible based on cohort and study stage/status
  • .Participants will complete the University of Pennsylvania Smell Identification Test (UPSIT).   This is a set of scratch and sniff, multiple choice questions to assess the ability to correctly identify odors. 
  • Participants will also enter information online about daily activities and may be asked to provide a saliva sample.
  • Study personnel will communicate with subjects via the participant portal, through email, and phone conversation. There will be no in-person interactions between IU study personnel and study participants. 

Eligibility of study

Inclusion Criteria for full PPMI Remote Data Collection Protocol:
1.    Enrolled in the PPMI Online study, or otherwise identified in pre-existing cohorts
2.    Male or female age 60 years or older (except age 30 years or older for SNCA, or rare genetic mutations, such as Parkin or Pink1)
3.    No self-reported PD, other parkinsonism, or dementia
4.    Ability to provide informed consent electronically
5.    Ability to complete remote assessments electronically

AND

7.     Meets any of the following criteria:
a)    Known PD associated mutation carrier - LRRK2, GBA, SNCA, or rare genetic mutations (such as Parkin or Pink1)
b)    History of polysomnography (PSG) REM behavior disorder (RBD)
c)    University of Pennsylvania Smell Identification Test (UPSIT) test documenting study thresholds for hyposmia
d)    Known synuclein biopsy positive
e)    Known health care information based on PPMI Online PRO measures,  including affected first degree relative, motor changes, autonomic dysfunction, sleep disorder, depression, anxiety, and fatigue.

Exclusion Criteria for full PPMI Remote Data Collection Protocol
1.    Received a diagnosis of Parkinson’s disease or related neurodegenerative disorder.
2.    Received a clinical diagnosis of dementia.
3.    Has been diagnosed with a significant medical or psychiatric illness that may limit ability to participate.

Interested in participating?

Enrollment in IU School of Medicine clinical trials is managed through our All IN for Health program. Visit allinforhealth.info to see if you're eligible and join the study.