A Pragmatic Randomized Trial Comparing Antipsychotics in Lewy Body Disease

Trial ID: NCT05590637

Interventional - Phase 4 - Recruiting

The primary objective of this study is to determine whether treatment with pimavanserin or quetiapine is associated with a greater improvement in psychosis when used in a routine clinical setting to treat hallucinations and/or delusions due to Parkinson's disease (PD) or dementia with Lewy bodies (DLB) - collectively referred to as Lewy body disease (LBD).

Conditions

• Parkinson's Disease Psychosis
• Dementia With Lewy Bodies

Interventions

• Pimavanserin
• Quetiapine

Eligibility

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

Sponsor

The University of Texas Health Science Center at San Antonio, Alzheimer's Association

Source: ClinicalTrials.gov

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