Parkinson's Disease and Movement Disorders Clinical Database

Parkinson Disease Clinical Trial

Official title:

Parkinson's Disease and Movement Disorders Clinical Database

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04997642
• Other study ID #: 820710
• Secondary ID: NIA U19
• Status: Recruiting
• Start date: September 30, 2019
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2023
• Source: University of Pennsylvania
• Contact: Sarah Shaw
• Phone: 215-829-7778
• Email: sarah.shaw[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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 (PDMDC) and the Hospital of the University of Pennsylvania.

The purpose of the research database is to have a comprehensive source of data that can be used for educational, research and patient care projects at the PDMDC. These data may be used for any study examining the relationship between treatment and clinical symptoms of patients with PD and related disorders. The main uses of the data are to:

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

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

• Improve our understanding of how best to identify, diagnose, and manage motor and non-motor symptoms of Parkinson's disease and related conditions Evaluate biological markers of disease or response to therapy

• Identify patients who may be candidates for participation in trials of new medications.

• Identify patients who may be interested in participating in educational or developmental activities

Participants are seen annually for the first 4 years, biennially thereafter. The participants continue in the study until study end, withdrawal, or death on study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Related Conditions & MeSH terms

• Dementia
• Lewy Body Dementia With Behavioral Disturbance
• Lewy Body Disease
• Movement Disorders
• Parkinson Disease
• Parkinson Disease Dementia
• Problem Behavior

Intervention

Behavioral:
• neuropsychiatric and cognitive testing questionnaires
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

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Identification and Diagnosis of Parkinson's disease	Improve our understanding of how best to identify, diagnose, and manage motor and non-motor symptoms of Parkinson's disease and related conditions	5 years

External Links

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