Degenerative Nigrostriatal Dysfunction in Drug-induced Parkinsonism

• Conditions: Secondary Parkinsonism; Parkinson's Disease
• Interventions: Other: no intervention

• Registration Number: NCT02361255
• Lead Sponsor: Corporal Michael J. Crescenz VA Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-06
• Study First Submitted QC: 2015-02-10
• Study First Posted: 2015-02-11
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-03
• Last Update Posted: 2018-04-05
• Primary Completion: 2019-02
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

antipsychotic treated patients with or without parkinsonism

Exclusion Criteria

parkinson's disease, dementia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
antipsychotic treated non-parkinsonian control	no intervention	subjects treated with antipsychotic but without parkinsonism
Drug-induced parkinsonism	no intervention	subjects with drug-induced parkinsonism

Primary Outcome Measures

Name	Time	Method
normal or abnormal DAT SPECT	baseline

Trial Locations

Locations (1)

PVAMC; 🇺🇸 Philadelphia, Pennsylvania, United States