NCT05590637 · The University of Texas Health Science Center at San Antonio
Comparing Antipsychotic Medications in LBD Over Time
(CAMELOT)
What this study is about
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).
View original scientific description
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).
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
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- San Antonio, Texas
Collaborators
Alzheimer's Association
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 9, 2025 · Source of record for eligibility and locations