Comparing Antipsychotic Medications in LBD Over Time

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT05590637
Phase
PHASE4
Status
Recruiting
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Conditions

  • Dementia With Lewy Bodies
  • Parkinson's Disease Psychosis

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Apr 22, 2022
Status verified
Sep 2025
Primary completion
Aug 31, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
94 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Neuropsychiatry Inventory Questionnaire (NPI-Q), Hallucinations + Delusions (H+D) [ Time Frame: Baseline to 6 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University Health SystemSan AntonioTexas78229
Sarah Horn, MD
[email protected]
210-450-0500
Carolyn Paiz, BS
[email protected]
210-450-8830
UT Health Science Center - San AntonioSan AntonioTexas78229
Carolyn Paiz
[email protected]
210-450-8830
Sarah Horn, MD (PRINCIPAL_INVESTIGATOR)

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