Parkinson's Disease and Movement Disorders Clinical Database

Sponsor
University of Pennsylvania (Other)
Overall Status
Recruiting
CT.gov ID
NCT04997642
Collaborator
National Institute on Aging (NIA) (NIH)
250
1
57
4.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: neuropsychiatric and cognitive testing questionnaires

Detailed 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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
250 participants
Observational Model:
Cohort
Time Perspective:
Other
Official Title:
Parkinson's Disease and Movement Disorders Clinical Database
Actual Study Start Date :
Sep 30, 2019
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Outcome Measures

Primary Outcome Measures

  1. Long term effects of Parkinson's disease [5 years]

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

  2. Genetic and Neurobiological factors [5 years]

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

Secondary Outcome Measures

  1. Identification and Diagnosis of Parkinson's disease [5 years]

    Improve our understanding of how best to identify, diagnose, and manage motor and non-motor symptoms of Parkinson's disease and related conditions

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Pennsylvania Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • University of Pennsylvania
  • National Institute on Aging (NIA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Daniel Weintraub, Professor of Psychiatry and Neurology, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT04997642
Other Study ID Numbers:
  • 820710
  • NIA U19
First Posted:
Aug 9, 2021
Last Update Posted:
Sep 27, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 27, 2021