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Comparing Antipsychotic Medications in LBD Over Time

NCT05590637 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2025-09-09

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Alzheimer's Association

    collaborator OTHER

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Sarah Horn, MD · University of Texas Health Science Center San Antonio

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-22
Primary Completion
2026-08-31
Completion
2027-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05590637 on ClinicalTrials.gov