Degenerative Nigrostriatal Dysfunction in Drug-induced Parkinsonism

NCT02361255 | Unknown

• 1 other identifier: 01481
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• normal or abnormal DAT SPECT

  baseline

Study Arms (2)

Drug-induced parkinsonism

subjects with drug-induced parkinsonism

Other: no intervention

antipsychotic treated non-parkinsonian control

subjects treated with antipsychotic but without parkinsonism

Other: no intervention

Interventions

no intervention OTHER

Drug-induced parkinsonism; antipsychotic treated non-parkinsonian control

Eligibility Criteria

• Age: 40 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

antipsychotic treated patients with or without parkinsonism

You may qualify if:

• antipsychotic treated patients with or without parkinsonism

You may not qualify if:

• parkinson's disease, dementia

Sponsors & Collaborators

• Corporal Michael J. Crescenz VA Medical Center: lead

Study Sites (1)

PVAMC

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease, Secondary; Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• James Morley

  PVAMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Morley

CONTACT

215-823-5800; james.morley@va.gov

Stephanie Wood

CONTACT

215-823-5800; Stephanie.wood3@va.gov

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2015
• First Posted: February 11, 2015
• Study Start: February 1, 2015
• Primary Completion: February 1, 2019
• Study Completion: April 1, 2019
• Last Updated: April 5, 2018

Record last verified: 2018-04

Locations

US (1)