Comparing Antipsychotic Medications in LBD Over Time (CAMELOT)

A Pragmatic Randomized Trial Comparing Antipsychotics in Lewy Body Disease

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).

Study Overview

• Status: Recruiting
• Conditions: Dementia With Lewy Bodies; Parkinson's Disease Psychosis
• Intervention / Treatment: Drug: Quetiapine; Drug: Pimavanserin

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.

• Study Type: Interventional
• Enrollment (Estimated): 94
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Carolyn Paiz, BS; Phone Number: 210-450-8830; Email: paizc@uthscsa.edu

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • UT Health Science Center - San Antonio
      • Contact: Carolyn Paiz; Phone Number: 210-450-8830; Email: paizc@uthscsa.edu
      • Principal Investigator: Sarah Horn, MD
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • University Health System
      • Contact: Carolyn Paiz, BS; Phone Number: 210-450-8830; Email: paizc@uthscsa.edu
      • Contact: Sarah Horn, MD; Phone Number: 210-450-0500; Email: horns@uthscsa.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Quetiapine; Dosage choice and further medication management will be at the discretion of the treating clinician, per routine clinical practice.; Other Names: Seroquel
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.	Drug: Pimavanserin; Dosage choice and further medication management will be at the discretion of the treating clinician, per routine clinical practice.; Other Names: Nuplazid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuropsychiatry Inventory Questionnaire (NPI-Q), Hallucinations + Delusions (H+D)	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.	Baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuropsychiatry Inventory Questionnaire (NPI-Q) total score	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.	Baseline to 6 months
Neuropsychiatry Inventory Questionnaire (NPI-Q) (anxiety)	Change in the neuropsychiatric inventory questionnaire item for anxiety, scored from 0-8 with a higher score indicating more severe anxiety.	Baseline to 6 months
Neuropsychiatry Inventory Questionnaire (NPI-Q) (agitation)	Change in the neuropsychiatric inventory questionnaire for agitation, scored from 0-8 with a higher score indicating more severe agitation.	Baseline to 6 months
Neuropsychiatry Inventory Questionnaire (NPI-Q) (nighttime behaviors)	Change in the neuropsychiatric inventory questionnaire for sleep disturbance, scored from 0-8 with a higher score indicating more severe sleep disturbances.	Baseline to 6 months
Mortality	Number of subjects who survived until the 6 month study assessment visit	6 months
Time to discontinuation of per-protocol medication	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.	Baseline to 6 months
MDS-UPDRS part 3	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.	Baseline to 6 months
CGIC, PGIC, CGI-C:CVR	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.	Baseline to 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication out-of-pocket cost	Amount of out of pocket costs spent on medications during the study	Baseline to 6 months
NPI-Q caregiver portion	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	Baseline to 6 months
Patient contact	Number of between visit patient encounters (phone, EMR messages)	Baseline to 6 months

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: Alzheimer's Association
• Investigators: Principal Investigator: Sarah Horn, MD, University of Texas Health Science Center San Antonio

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2022
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 21, 2022

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: quetiapine; psychosis; hallucinations; pimavanserin; delusions
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dementia; Psychotic Disorders; Parkinson Disease; Mental Disorders; Lewy Body Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Antiparkinson Agents; Anti-Dyskinesia Agents; Quetiapine Fumarate; Pimavanserin
• Other Study ID Numbers: 22-0198H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No