Recruiting

Observational Study

Sponsor:

Corporal Michael J. Crescenz VA Medical Center

Code:

NCT02361255

Conditions

Secondary Parkinsonism

Parkinson's Disease

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

no intervention

Study Details

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.

Conditions

Secondary Parkinsonism

Parkinson's Disease

Study ID

NCT02361255

Start date

Feb, 2015

Status verified date

Apr, 2018

Completion date

Apr, 2019

Anticipated

Primary completion date

Feb, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

antipsychotic treated patients with or without parkinsonism

Exclusion Criteria:

parkinson's disease, dementia

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

Drug-induced parkinsonism

subjects with drug-induced parkinsonism

antipsychotic treated non-parkinsonian control

subjects treated with antipsychotic but without parkinsonism

Interventions

no intervention

Primary outcome measure

  • normal or abnormal DAT SPECT [ Time Frame: baseline ]

Central Contacts and Locations

Locations

PVAMC

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

More Information

Sponsor

Corporal Michael J. Crescenz VA Medical Center

Last update posted

Apr 5, 2018

Last verified

Apr, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Corporal Michael J. Crescenz VA Medical Center on 2018-04-05.