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Degenerative Nigrostriatal Dysfunction in Drug-induced Parkinsonism

Degenerative Nigrostriatal Dysfunction in Drug-induced Parkinsonism

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02361255
Enrollment
40
Registered
2015-02-11
Start date
2015-02-28
Completion date
2019-04-30
Last updated
2018-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's Disease, Secondary Parkinsonism

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.

Interventions

OTHERno intervention

Sponsors

Corporal Michael J. Crescenz VA Medical Center
Lead SponsorFED

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 89 Years
Healthy volunteers
No

Inclusion criteria

antipsychotic treated patients with or without parkinsonism

Exclusion criteria

parkinson's disease, dementia

Design outcomes

Primary

MeasureTime frame
normal or abnormal DAT SPECTbaseline

Countries

United States

Contacts

Primary ContactJames Morley
james.morley@va.gov215-823-5800
Backup ContactStephanie Wood
Stephanie.wood3@va.gov215-823-5800

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026