Degenerative Nigrostriatal Dysfunction in Drug-induced Parkinsonism
NCT ID: NCT02361255
Last Updated: 2018-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
40 participants
OBSERVATIONAL
2015-02-28
2019-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Drug-induced parkinsonism
subjects with drug-induced parkinsonism
no intervention
antipsychotic treated non-parkinsonian control
subjects treated with antipsychotic but without parkinsonism
no intervention
Interventions
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no intervention
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
40 Years
89 Years
ALL
No
Sponsors
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Corporal Michael J. Crescenz VA Medical Center
FED
Responsible Party
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Principal Investigators
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James Morley
Role: PRINCIPAL_INVESTIGATOR
PVAMC
Locations
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PVAMC
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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01481
Identifier Type: -
Identifier Source: org_study_id
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