Clinical Trial: Degenerative Nigrostriatal Dysfunction in Drug-induced Parkinsonism

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Degenerative Nigrostriatal Dysfunction in Drug-induced 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.

Detailed Summary:
Sponsor: Corporal Michael J. Crescenz VA Medical Center

Current Primary Outcome: normal or abnormal DAT SPECT [ Time Frame: baseline ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Corporal Michael J. Crescenz VA Medical Center

Dates:
Date Received: February 6, 2015
Date Started: February 2015
Date Completion: April 2017
Last Updated: August 25, 2015
Last Verified: August 2015