Degenerative Nigrostriatal Dysfunction in Drug-induced Parkinsonism

Parkinson's Disease Clinical Trial

Official title:

Degenerative Nigrostriatal Dysfunction in Drug-induced Parkinsonism

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02361255
• Other study ID #: 01481
• Status: Recruiting
• First received: February 6, 2015
• Last updated: April 3, 2018
• Start date: February 2015
• Est. completion date: April 2019

Study information

• Verified date: April 2018
• Source: Corporal Michael J. Crescenz VA Medical Center
• Contact: James Morley
• Phone: 215-823-5800
• Email: james.morley[@]va.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 89 Years

Eligibility

Inclusion Criteria:

antipsychotic treated patients with or without parkinsonism

Exclusion Criteria:

parkinson's disease, dementia

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson Disease, Secondary
• Parkinson's Disease
• Parkinsonian Disorders
• Secondary Parkinsonism

Intervention

Other:
• no intervention

Locations

Country	Name	City	State
United States	PVAMC	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Corporal Michael J. Crescenz VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	normal or abnormal DAT SPECT		baseline