CAMELOT: Comparing Antipsychotic Medications in LBD Over Time

Sponsor

The University of Texas Health Science Center at San Antonio (Other)

Overall Status

Recruiting

CT.gov ID

NCT05590637

Collaborator

Alzheimer's Association (Other)

Enrollment

Location

Arms

35.3

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease Psychosis Dementia With Lewy Bodies	Drug: Pimavanserin Drug: Quetiapine	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

94 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Pragmatic Randomized Trial Comparing Antipsychotics in Lewy Body Disease

Actual Study Start Date :

Apr 22, 2022

Anticipated Primary Completion Date :

Oct 1, 2024

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: quetiapine	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	Drug: Pimavanserin Dosage choice and further medication management will be at the discretion of the treating clinician, per routine clinical practice. Other Names: Nuplazid

Arm

Intervention/Treatment

Active Comparator: quetiapine

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

Drug: Pimavanserin

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

Other Names:

Nuplazid

Outcome Measures

Primary Outcome Measures

Neuropsychiatry Inventory Questionnaire (NPI-Q), Hallucinations + Delusions (H+D) [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 Outcome Measures

Neuropsychiatry Inventory Questionnaire (NPI-Q) total score [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.
Neuropsychiatry Inventory Questionnaire (NPI-Q) (anxiety) [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.
Neuropsychiatry Inventory Questionnaire (NPI-Q) (agitation) [Baseline to 6 months]
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) [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.
Mortality [6 months]
Number of subjects who survived until the 6 month study assessment visit
Time to discontinuation of per-protocol medication [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.
MDS-UPDRS part 3 [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.
CGIC, PGIC, CGI-C:CVR [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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