NCT04997642

Brief Summary

The research database contains demographic and family history information, longitudinal information on the clinical symptoms, neuropsychological profile and treatments, stored biological samples, and brain images of patients with Parkinson's disease and related disorders receiving care at the Parkinson's disease and Movement Disorders Center and the Hospital of the University of Pennsylvania.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
41mo left

Started Sep 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Sep 2019Sep 2029

Study Start

First participant enrolled

September 30, 2019

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 9, 2021

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2029

Last Updated

October 7, 2025

Status Verified

October 1, 2025

Enrollment Period

10 years

First QC Date

August 1, 2021

Last Update Submit

October 1, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Long term effects of Parkinson's disease

    Determine the long term effects of Parkinson's disease and related conditions, including predictors of its motor and non-motor symptoms

    5 years

  • Genetic and Neurobiological factors

    Identify genetic and other neurobiological factors related to the risk of developing Parkinson's disease and related disorders and their course

    5 years

Secondary Outcomes (1)

  • Identification and Diagnosis of Parkinson's disease

    5 years

Interventions

Demographic data such as race, sex, age Family History Risk Factor Questionnaire Hoehn and Yahr Stage UPDRS Parkinson's symptom checklist Medication list Neuropsychological Test Battery Behavioral Exams * Geriatric Depression Scale Quality of Life Questionnaire * PDQ-39, SF-12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Population will be derived from outpatient clinics, support groups, self-referral, and community members.

You may qualify if:

  • Any person who receives medical care for the diagnosis of Parkinson's disease with mild cognitive impairment (MCI) or dementia may be eligible to participate in the research database. There are no limitations for database participation based on age, disease severity or presence of cognitive impairments, as long as the person is able to complete the research assessments.

You may not qualify if:

  • Absence of Parkinson's disease diagnosis. There are no limitations for database participation based on age, disease severity or presence of cognitive impairments, as long as the person is able to complete the research assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma and cerebrospinal fluid obtained with patient\'s consent. Biological samples including blood and spinal fluid may be collected from each database participant. Each participant will be given the option of allowing the collection of none, some, or both of the biological samples. Samples will be stored in a secure facility at the University of Pennsylvania Department of Pathology and Laboratory Medicine. If the subject consents, approximately 20 ml (4 teaspoons) of blood will be collected, and 25 ml (2 tablespoons) of spinal fluid will be collected.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
15 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry and Neurology

Study Record Dates

First Submitted

August 1, 2021

First Posted

August 9, 2021

Study Start

September 30, 2019

Primary Completion (Estimated)

September 15, 2029

Study Completion (Estimated)

September 15, 2029

Last Updated

October 7, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

The data in the research database are available to researchers both within the PDMDC and other researchers at the University and at other Institutions. Any release of data outside the PDMDC will be reviewed by the Principal Investigator and the Director of the PDMDC to ensure that the study is scientifically sound, that the research projects are covered by the subject's informed consent, and are compliant with HIPAA regulations. Once the study has been approved, a de-identified data extract is prepared and the data necessary to conduct the study are extracted from the database.

Shared Documents
STUDY PROTOCOL, ICF

Locations