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Recruiting NCT05590637

Comparing Antipsychotic Medications in LBD Over Time

Phase IV Interventional Parkinson's Disease Psychosis Dementia With Lewy Bodies

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pimavanserin, Quetiapine.
Who it may be relevant to
Registry conditions: Parkinson's Disease Psychosis, Dementia With Lewy Bodies. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Pragmatic Randomized Trial Comparing Antipsychotics in Lewy Body Disease

Overview

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.

Interventions

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

Primary outcome measures

  • Neuropsychiatry Inventory Questionnaire (NPI-Q), Hallucinations + Delusions (H+D) [Time frame: Baseline to 6 months]
Secondary outcome measures (8)
  • Neuropsychiatry Inventory Questionnaire (NPI-Q) total score [Time frame: Baseline to 6 months]
  • Neuropsychiatry Inventory Questionnaire (NPI-Q) (anxiety) [Time frame: Baseline to 6 months]
  • Neuropsychiatry Inventory Questionnaire (NPI-Q) (agitation) [Time frame: Baseline to 6 months]
  • Neuropsychiatry Inventory Questionnaire (NPI-Q) (nighttime behaviors) [Time frame: Baseline to 6 months]
  • Mortality [Time frame: 6 months]
  • Time to discontinuation of per-protocol medication [Time frame: Baseline to 6 months]
  • MDS-UPDRS part 3 [Time frame: Baseline to 6 months]
  • CGIC, PGIC, CGI-C:CVR [Time frame: Baseline to 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • University Health System — San Antonio
  • UT Health Science Center - San Antonio — San Antonio

Publications

  • 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

Identifiers

NCT: NCT05590637 · 22-0198H

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗