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Comparing Antipsychotic Medications in LBD Over Time

NCT05590637 · The University of Texas Health Science Center at San Antonio
In plain English

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Official title
A Pragmatic Randomized Trial Comparing Antipsychotics in Lewy Body Disease
About this study
Psychosis (hallucinations and delusions) is a common problem in Parkinson's disease (PD) and dementia with Lewy bodies (DLB). PD is a common neurodegenerative disorder that causes movement, cognitive, and psychiatric symptoms. DLB is a similar disorder, though causes more severe cognitive and psychiatric problems. Psychosis is highly prevalent among people with PD and DLB, often manifesting as visual hallucinations or paranoid delusions. Up to 60% of people with PD will experience psychosis over the course of their disease. Psychosis is associated with increased mortality, caregiver burden, and poorer quality of life. More study is needed to determine the best way to treat psychosis in PD and DLB. Currently, both quetiapine and pimavanserin are used in clinical practice for psychosis in PD and DLB. However, few comparison studies have been done and it is unclear if one medication is superior to the other. This will be a clinical trial comparing quetiapine and pimavanserin among patients with psychosis due to PD or DLB requiring initiation of a medication. Patients will be randomized to quetiapine or pimavanserin and improvement in psychosis at 6 months will be compared between the groups.
Eligibility criteria
Inclusion Criteria: * Patients seen in the neurology clinic at UT Health San Antonio * Diagnosed with psychosis due to PD or DLB * Requiring initiation of an antipsychotic medication * Clinical equipoise between quetiapine and pimavanserin must exist * The prescribing provider must be comfortable prescribing and managing both quetiapine and pimavanserin Exclusion Criteria: * Medical contraindication to either medication * Caregiver unavailable to complete NPI-Q * Currently taking an antipsychotic medication * Prescribing provider unwilling to manage either medication
Study design
Enrollment target: 94 participants
Allocation: randomized
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2022-04-22
Estimated completion: 2027-02
Last updated: 2025-09-09
Interventions
Drug: PimavanserinDrug: Quetiapine
Primary outcomes
  • Neuropsychiatry Inventory Questionnaire (NPI-Q), Hallucinations + Delusions (H+D) (Baseline to 6 months)
Sponsor
The University of Texas Health Science Center at San Antonio · other
With: Alzheimer's Association
Contacts & investigators
ContactCarolyn Paiz, BS · contact · paizc@uthscsa.edu · 210-450-8830
InvestigatorSarah Horn, MD · principal_investigator, The University of Texas Health Science Center at San Antonio
All locations (2)
University Health SystemRecruiting
San Antonio, Texas, United States
UT Health Science Center - San AntonioRecruiting
San Antonio, Texas, United States