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NCT Number: NCT05590637

Comparing Antipsychotic Medications in LBD Over Time

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).

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Key information

Conditions

Parkinson's Disease Psychosis Basal Ganglia Diseases Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Delusions Dementia Dementia With Lewy Bodies Hallucinations Lewy Body Disease Mental Disorders Movement Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Perceptual Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms Synucleinopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UT Health Science Center - San Antonio, San Antonio, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pimavanserin

Drug

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

Other names: Nuplazid

Quetiapine

Drug

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

Other names: Seroquel

Primary outcomes

  1. 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.

Secondary outcomes

  1. Neuropsychiatry Inventory Questionnaire (NPI-Q) total score

    Time frame: Baseline to 6 months

    Change in the total neuropsychiatric inventory questionnaire score, which includes 12 items, each scored from 0-8 with a higher score indicating more severe symptoms.

  2. Neuropsychiatry Inventory Questionnaire (NPI-Q) (anxiety)

    Time frame: Baseline to 6 months

    Change in the neuropsychiatric inventory questionnaire item for anxiety, scored from 0-8 with a higher score indicating more severe anxiety.

  3. Neuropsychiatry Inventory Questionnaire (NPI-Q) (agitation)

    Time frame: Baseline to 6 months

    Change in the neuropsychiatric inventory questionnaire for agitation, scored from 0-8 with a higher score indicating more severe agitation.

  4. Neuropsychiatry Inventory Questionnaire (NPI-Q) (nighttime behaviors)

    Time frame: Baseline to 6 months

    Change in the neuropsychiatric inventory questionnaire for sleep disturbance, scored from 0-8 with a higher score indicating more severe sleep disturbances.

  5. Mortality

    Time frame: 6 months

    Number of subjects who survived until the 6 month study assessment visit

  6. Time to discontinuation of per-protocol medication

    Time frame: Baseline to 6 months

    Will examine whether participants continued the chosen medication until study completion or if they either discontinued the study medication or added the other study medication.

  7. MDS-UPDRS part 3

    Time frame: Baseline to 6 months

    Unified Parkinson's Disease Rating Scale, motor score. The motor examination scale consists of 33 items graded 0-4 points with an overall possible score of 0-132 points. A higher score indicates a higher burden of motor symptoms.

  8. CGIC, PGIC, CGI-C:CVR

    Time frame: Baseline to 6 months

    Clinician, patient, and caregiver global impressions of change. Each is a single item assessment rated from 1 (very much improved) to 7 (very much worse). A higher score indicates worsening symptoms.

Other outcomes

  1. Medication out-of-pocket cost

    Time frame: Baseline to 6 months

    Amount of out of pocket costs spent on medications during the study

  2. NPI-Q caregiver portion

    Time frame: Baseline to 6 months

    Change in the total of the caregiver distress items of the neuropsychiatric inventory. The scale contains 12 items, each scored from 0-5 (least to most distress). Possible scores Range from 0-60 with a lower score indicating less caregiver distress

  3. Patient contact

    Time frame: Baseline to 6 months

    Number of between visit patient encounters (phone, EMR messages)

Study contacts

Contact information is provided by the study sponsor or research team.

Carolyn Paiz, BS

CONTACT

[email protected]

210-450-8830

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • Alzheimer's Association

Registry information

Official study title

A Pragmatic Randomized Trial Comparing Antipsychotics in Lewy Body Disease

Acronym: CAMELOT

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Oct 21, 2022
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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