- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02361255
Degenerative Nigrostriatal Dysfunction in Drug-induced Parkinsonism
Parkinson's disease (PD) and Drug-induced Parkinsonism (DIP) can be clinically indistinguishable and DIP sometimes represents "unmasking of underlying PD. The objective of this study is to determine the relationship of underlying Parkinson's disease (PD) to the incidence and clinical outcome in DIP using non-motor assessments as a marker for nigrostriatal degeneration.
Research Design: This is a nested case-control design to investigate risk factors associated with the development of DIP and persistent Parkinsonism after antipsychotic (AP) withdrawal (a potential clinical marker of underlying PD). Target enrollment is 45 subjects.
Methodology: We will examine objective olfactory function (via objective olfactory testing), other non-motor symptoms of PD (via standardized validated questionnaires), and motor findings (via clinical exam and quantitative gait analysis) in: 1) DIP patients (30 subjects) compared to AP-treated patients without Parkinsonism (15 subjects) and 2) patients with persistent Parkinsonism compared to those whose symptoms resolve in the DIP cohort followed prospectively after a change in AP treatment. Additionally, in patients where it was performed clinically, we will evaluate dopamine transporter SPECT imaging (DaTI) as a marker of nigrostriatal integrity examining the ability of qualitative and semi-quantitative analysis to distinguish between pharmacologic and degenerative Parkinsonism. We will also measure serum uric acid and Apolipoprotein A1, two putative biomarkers in early PD, and examine their relationship with clinical and radiologic status.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: James Morley
- Phone Number: 5934 215-823-5800
- Email: james.morley@va.gov
Study Contact Backup
- Name: Stephanie Wood
- Phone Number: 5934 215-823-5800
- Email: Stephanie.wood3@va.gov
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- PVAMC
-
Contact:
- James Morley
- Phone Number: 5934 215-823-5800
- Email: james.morley@va.gov
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
antipsychotic treated patients with or without parkinsonism
Exclusion Criteria:
parkinson's disease, dementia
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Drug-induced parkinsonism
subjects with drug-induced parkinsonism
|
|
antipsychotic treated non-parkinsonian control
subjects treated with antipsychotic but without parkinsonism
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
normal or abnormal DAT SPECT
Time Frame: baseline
|
baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: James Morley, PVAMC
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01481
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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