Clinical trial NCT05590637: Comparing Antipsychotic Medications in LBD Over Time
Official title: A Pragmatic Randomized Trial Comparing Antipsychotics in Lewy Body Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Parkinson's Disease Psychosis
Dementia With Lewy Bodies
Keywords: quetiapine
pimavanserin
psychosis
hallucinations
delusions
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: Alzheimer's Association
First posted: 2022-10-21
Enrollment: 94
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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

Primary outcomes:
measure: Neuropsychiatry Inventory Questionnaire (NPI-Q), Hallucinations + Delusions (H+D)
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Neuropsychiatry Inventory Questionnaire (NPI-Q) total score
timeFrame: Baseline to 6 months
measure: Neuropsychiatry Inventory Questionnaire (NPI-Q) (anxiety)
timeFrame: Baseline to 6 months
measure: Neuropsychiatry Inventory Questionnaire (NPI-Q) (agitation)
timeFrame: Baseline to 6 months
measure: Neuropsychiatry Inventory Questionnaire (NPI-Q) (nighttime behaviors)
timeFrame: Baseline to 6 months
measure: Mortality
timeFrame: 6 months
measure: Time to discontinuation of per-protocol medication
timeFrame: Baseline to 6 months
measure: MDS-UPDRS part 3
timeFrame: Baseline to 6 months
measure: CGIC, PGIC, CGI-C:CVR
timeFrame: Baseline to 6 months
Other outcomes:
measure: Medication out-of-pocket cost
timeFrame: Baseline to 6 months
measure: NPI-Q caregiver portion
timeFrame: Baseline to 6 months
measure: Patient contact
timeFrame: Baseline to 6 months
Locations:
city: San Antonio
country: United States
facility: University Health System
state: Texas
city: San Antonio
country: United States
facility: UT Health Science Center - San Antonio
state: Texas
Study officials:
affiliation: University of Texas Health Science Center San Antonio
name: Sarah Horn, MD
role: PRINCIPAL_INVESTIGATOR
References: