Comparing Antipsychotic Medications in LBD Over Time

NCT05590637 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 22-0198H
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 2

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).

Conditions

Parkinson's Disease Psychosis; Dementia With Lewy Bodies

Keywords

quetiapine; pimavanserin; psychosis; hallucinations; delusions

Outcome Measures

Primary Outcomes (1)

• Neuropsychiatry Inventory Questionnaire (NPI-Q), Hallucinations + Delusions (H+D)

  Change in the Hallucinations + Delusions sub-score of the neuropsychiatric inventory questionnaire. Each NPI-Q item is scored by severity (1-3), and distress to caregiver (0-5), then added together (range 0-8) with a higher score indicating greater severity.

  Baseline to 6 months

Secondary Outcomes (8)

• Neuropsychiatry Inventory Questionnaire (NPI-Q) total score

  Baseline to 6 months

• Neuropsychiatry Inventory Questionnaire (NPI-Q) (anxiety)

  Baseline to 6 months

• Neuropsychiatry Inventory Questionnaire (NPI-Q) (agitation)

  Baseline to 6 months

• Neuropsychiatry Inventory Questionnaire (NPI-Q) (nighttime behaviors)

  Baseline to 6 months

• Mortality

  6 months

Other Outcomes (3)

• Medication out-of-pocket cost

  Baseline to 6 months

• NPI-Q caregiver portion

  Baseline to 6 months

• Patient contact

  Baseline to 6 months

Study Arms (2)

quetiapine

ACTIVE COMPARATOR

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.

Drug: Quetiapine

pimavanserin

ACTIVE COMPARATOR

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.

Drug: Pimavanserin

Interventions

Pimavanserin DRUG

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

Also known as: Nuplazid

pimavanserin

Quetiapine DRUG

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

Also known as: Seroquel

quetiapine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Medical contraindication to either medication
• Caregiver unavailable to complete NPI-Q
• Currently taking an antipsychotic medication
• Prescribing provider unwilling to manage either medication

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• Alzheimer's Association: collaborator

Study Sites (2)

University Health System

San Antonio, Texas, 78229, United States

RECRUITING

UT Health Science Center - San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Related Publications (1)

• Tran N, Wang CP, Seshadri S, Coss P, Vaou OE, Saadatpour L, Paiz C, Solis D, Grimaldo J, Erskine S, Horn S. Pragmatic trial design enhances diversity and retention among research participants with Lewy body diseases. NPJ Dement. 2026;2(1):10. doi: 10.1038/s44400-026-00059-x. Epub 2026 Feb 2.

  PMID: 41640857 DERIVED

MeSH Terms

Conditions

Lewy Body Disease; Psychotic Disorders; Hallucinations; Delusions

Interventions

pimavanserin; Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sarah Horn, MD

  University of Texas Health Science Center San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolyn Paiz, BS

CONTACT

210-450-8830; paizc@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 21, 2022
• Study Start: April 22, 2022
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)