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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04997642
Other study ID # 820710
Secondary ID NIA U19
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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