Comparing Antipsychotic Medications in LBD Over Time (CAMELOT)

The University of Texas System (UT)

Status and phase: Enrolling; Phase 4

Conditions: Parkinson's Disease Psychosis; Dementia With Lewy Bodies

Treatments: Drug: Quetiapine; Drug: Pimavanserin

Study type: Interventional

Funder types: Other

Identifiers

NCT05590637

22-0198H

Details and patient eligibility

About

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).

Full 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.

Enrollment: 94 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

quetiapine

Active Comparator group

Description:

Elderly patients with dementia-related psychosis will be treated with quetiapine, an atypical antipsychotic indicated for the treeatment of: schizophrenia, bipolar I manic episodes and bipolar depressive episodes.

Treatment:

Drug: Quetiapine

pimavanserin

Active Comparator group

Description:

Elderly patients with dementia-related psychosis will be treated with pimavanserin, an atypical antipsychotic indicated for treatment of hallucinations and delusions associated with Parkinson's disease.

Treatment:

Drug: Pimavanserin