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Comparing Antipsychotic Medications in LBD Over Time (CAMELOT)

Primary Purpose

Parkinson's Disease Psychosis, Dementia With Lewy Bodies

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pimavanserin
Quetiapine
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease Psychosis focused on measuring quetiapine, pimavanserin, psychosis, hallucinations, delusions

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UT Health Science Center - San AntonioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

quetiapine

pimavanserin

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 18, 2022
Last Updated
October 18, 2022
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
Alzheimer's Association
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1. Study Identification

Unique Protocol Identification Number
NCT05590637
Brief Title
Comparing Antipsychotic Medications in LBD Over Time
Acronym
CAMELOT
Official Title
A Pragmatic Randomized Trial Comparing Antipsychotics in Lewy Body Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2022 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
Alzheimer's Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease Psychosis, Dementia With Lewy Bodies
Keywords
quetiapine, pimavanserin, psychosis, hallucinations, delusions

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
quetiapine
Arm Type
Active Comparator
Arm Title
pimavanserin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Pimavanserin
Other Intervention Name(s)
Nuplazid
Intervention Description
Dosage choice and further medication management will be at the discretion of the treating clinician, per routine clinical practice.
Intervention Type
Drug
Intervention Name(s)
Quetiapine
Other Intervention Name(s)
Seroquel
Intervention Description
Dosage choice and further medication management will be at the discretion of the treating clinician, per routine clinical practice.
Primary Outcome Measure Information:
Title
Neuropsychiatry Inventory Questionnaire (NPI-Q), Hallucinations + Delusions (H+D)
Description
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.
Time Frame
Baseline to 6 months
Secondary Outcome Measure Information:
Title
Neuropsychiatry Inventory Questionnaire (NPI-Q) total score
Description
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.
Time Frame
Baseline to 6 months
Title
Neuropsychiatry Inventory Questionnaire (NPI-Q) (anxiety)
Description
Change in the neuropsychiatric inventory questionnaire item for anxiety, scored from 0-8 with a higher score indicating more severe anxiety.
Time Frame
Baseline to 6 months
Title
Neuropsychiatry Inventory Questionnaire (NPI-Q) (agitation)
Description
Change in the neuropsychiatric inventory questionnaire for agitation, scored from 0-8 with a higher score indicating more severe agitation.
Time Frame
Baseline to 6 months
Title
Neuropsychiatry Inventory Questionnaire (NPI-Q) (nighttime behaviors)
Description
Change in the neuropsychiatric inventory questionnaire for sleep disturbance, scored from 0-8 with a higher score indicating more severe sleep disturbances.
Time Frame
Baseline to 6 months
Title
Mortality
Description
Number of subjects who survived until the 6 month study assessment visit
Time Frame
6 months
Title
Time to discontinuation of per-protocol medication
Description
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.
Time Frame
Baseline to 6 months
Title
MDS-UPDRS part 3
Description
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.
Time Frame
Baseline to 6 months
Title
CGIC, PGIC, CGI-C:CVR
Description
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.
Time Frame
Baseline to 6 months
Other Pre-specified Outcome Measures:
Title
Medication out-of-pocket cost
Description
Amount of out of pocket costs spent on medications during the study
Time Frame
Baseline to 6 months
Title
NPI-Q caregiver portion
Description
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
Time Frame
Baseline to 6 months
Title
Patient contact
Description
Number of between visit patient encounters (phone, EMR messages)
Time Frame
Baseline to 6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carolyn Paiz, BS
Phone
210-450-8830
Email
paizc@uthscsa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Horn, MD
Organizational Affiliation
University of Texas Health Science Center San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Health Science Center - San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carolyn Paiz
Phone
210-450-8830
Email
paizc@uthscsa.edu
First Name & Middle Initial & Last Name & Degree
Sarah Horn, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparing Antipsychotic Medications in LBD Over Time

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