Comparing Antipsychotic Medications in LBD Over Time

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-22

Study Completion Date

2027-02-28

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Parkinson's Disease Psychosis Dementia With Lewy Bodies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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quetiapine

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.

Group Type ACTIVE_COMPARATOR

Quetiapine

Intervention Type DRUG

Dosage choice and further medication management will be at the discretion of the treating clinician, per routine clinical practice.

pimavanserin

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.

Group Type ACTIVE_COMPARATOR

Pimavanserin

Intervention Type DRUG

Dosage choice and further medication management will be at the discretion of the treating clinician, per routine clinical practice.

Interventions

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Pimavanserin

Dosage choice and further medication management will be at the discretion of the treating clinician, per routine clinical practice.

Intervention Type DRUG

Quetiapine

Dosage choice and further medication management will be at the discretion of the treating clinician, per routine clinical practice.

Intervention Type DRUG

Other Intervention Names

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Nuplazid Seroquel

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No