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CAMELOT

RecruitingPhase 4

Comparing Antipsychotic Medications in LBD Over Time

A Pragmatic Randomized Trial Comparing Antipsychotics in Lewy Body Disease

Assets

Pimavanserin / Quetiapine

Listed sites

2

Recruiting sites

2

Enrollment

94

estimated

Study population

Lewy body dementia

Key I/E criterion

•Dementia with Lewy bodies

Primary endpoint

•Neuropsychiatric Inventory (NPI)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID22-0198H
NCT IDNCT05590637

Timeline

Milestones

Study start2022-04-22actual
Study first posted2022-10-21actual
Last update posted2025-09-09actual
Primary completion2026-08estimated (month precision)
Study completion2027-02estimated (month precision)

Assets

Drug assets

PimavanserinQuetiapine

Study populations

Who this study enrolls

Lewy body dementia

Eligibility

Who can enroll

SexAll
Healthy volunteersNot accepted

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

Endpoints (12)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Behavior / neuropsychiatric
6
Other (unclassified)
4
Caregiver / quality of life
1
Other clinical outcomes
1

Behavior / neuropsychiatric

6 endpoints
Primary/protocol endpoint

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

Time frame:Baseline to 6 months

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Neuropsychiatry Inventory Questionnaire (NPI-Q) total score

Time frame:Baseline to 6 months

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Neuropsychiatry Inventory Questionnaire (NPI-Q) (anxiety)

Time frame:Baseline to 6 months

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Neuropsychiatry Inventory Questionnaire (NPI-Q) (agitation)

Time frame:Baseline to 6 months

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline to 6 months

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Other/protocol endpoint

NPI-Q caregiver portion

Time frame:Baseline to 6 months

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Caregiver / quality of life

1 endpoint
Secondary/protocol endpoint

CGIC, PGIC, CGI-C:CVR

Time frame:Baseline to 6 months

descriptive

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Mortality

Time frame:6 months

event count, event

Other (unclassified)

4 endpoints
Secondary/protocol endpoint/low confidence

Time to discontinuation of per-protocol medication

Time frame:Baseline to 6 months

time to event, event

Secondary/protocol endpoint/low confidence

MDS-UPDRS part 3

Time frame:Baseline to 6 months

descriptive

Other/protocol endpoint/low confidence

Medication out-of-pocket cost

Time frame:Baseline to 6 months

descriptive

Other/protocol endpoint/low confidence

Patient contact

Time frame:Baseline to 6 months

event count, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.