Parkinson DiseaseNCT04997642
Parkinson's Disease and Movement Disorders Clinical Database
An observational study of Parkinson Disease and Parkinson Disease Dementia, run by University of Pennsylvania at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Parkinson Disease Dementia, Lewy Body Parkinson Disease
- What is being tested?
- neuropsychiatric and cognitive testing questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2019to 15 Sep 2029
- How long will I take part?
- 15 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population will be derived from outpatient clinics, support groups, self-referral, and community members.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Sarah Shaw, 215-615-0838, sarah.shaw@pennmedicine.upenn.edu
Gina Mamikonyan, 215-615-3085, eugeniam@pennmedicine.upenn.edu
About this study
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.
Read the 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.
- Conditions
- Parkinson Disease, Parkinson Disease Dementia, Lewy Body Parkinson Disease, Lewy Body Dementia With Behavioral Disturbance
- Being tested
- neuropsychiatric and cognitive testing questionnaires
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neuropsychiatric and cognitive testing questionnairesBehavioural
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 5 years
Secondary outcomes (1)
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start30 Sep 2019
- Primary completion15 Sep 2029 (estimated)
- Study completion15 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 250 participants (estimated)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Daniel Weintraub, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997642
- Sponsor's protocol ID
- 820710
- Other IDs
- NIH P01
- Status last verified
- Oct 2026
- First submitted
- 1 Aug 2021
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parkinson's Disease and Movement Disorders Clinical Database
- ClinicalTrials.gov ID
- NCT04997642
- Acronym / sponsor ID
- 820710
- Conditions
- Parkinson Disease, Parkinson Disease Dementia, Lewy Body Parkinson Disease, Lewy Body Dementia With Behavioral Disturbance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 30 Sep 2019 (actual)
- Primary completion
- 15 Sep 2029 (estimated)
- Study completion
- 15 Sep 2029 (estimated)
- First posted
- 9 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 15 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population will be derived from outpatient clinics, support groups, self-referral, and community members.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| neuropsychiatric and cognitive testing questionnairesDemographic 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 | Behavioural | – |
Primary outcome
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
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
1 secondary outcome
Identification and Diagnosis of Parkinson's disease
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Parkinson Disease Dementia, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eugenia Mamikonyan (215-615-3085, eugenia.mamikonyan@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long term effects of Parkinson's disease (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.