Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Parkinson's Disease and Movement Disorders Clinical Database

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04997642
Recruitment Status : Recruiting
First Posted : August 9, 2021
Last Update Posted : September 27, 2021
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Daniel Weintraub, University of Pennsylvania

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
Parkinson Disease Parkinson Disease Dementia Lewy Body Parkinson Disease Lewy Body Dementia With Behavioral Disturbance 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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 5 Years
Official Title: Parkinson's Disease and Movement Disorders Clinical Database
Actual Study Start Date : September 30, 2019
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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


Primary Outcome Measures :
  1. Long term effects of Parkinson's disease [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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


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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Population will be derived from outpatient clinics, support groups, self-referral, and community members.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04997642


Contacts
Layout table for location contacts
Contact: Sarah Shaw 215-829-7778 sarah.shaw@pennmedicine.upenn.edu

Locations
Layout table for location information
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Sarah Shaw    215-829-7778    sarah.shaw@pennmedicine.upenn.edu   
Contact: Gina Mamikonyan    215-615-3085    eugeniam@pennmedicine.upenn.edu   
Sponsors and Collaborators
University of Pennsylvania
National Institute on Aging (NIA)
Additional Information:
Layout table for additonal information
Responsible Party: Daniel Weintraub, Professor of Psychiatry and Neurology, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04997642    
Other Study ID Numbers: 820710
NIA U19 ( Other Identifier: NIA )
First Posted: August 9, 2021    Key Record Dates
Last Update Posted: September 27, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.

Supporting Materials: Study Protocol
Informed Consent Form (ICF)

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Dementia
Movement Disorders
Lewy Body Disease
Problem Behavior
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Synucleinopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Behavioral Symptoms