Parkinson's Disease PsychosisPhase 4CAMELOTNCT05590637
Comparing Antipsychotic Medications in LBD Over Time
A Phase 4 study testing Pimavanserin and Quetiapine in people with Parkinson's Disease Psychosis and Dementia With Lewy Bodies, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson's Disease Psychosis, Dementia With Lewy Bodies
- What is being tested?
- Pimavanserin and Quetiapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Apr 2022to Feb 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Medical contraindication to either medication
- Caregiver unavailable to complete NPI-Q
- Currently taking an antipsychotic medication
- Prescribing provider unwilling to manage either medication
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University Health System
San Antonio, Texas, 78229
Sarah Horn, MD, 210-450-0500, horns@uthscsa.edu
Carolyn Paiz, BS, 210-450-8830, paizc@uthscsa.edu
- Recruiting
UT Health Science Center - San Antonio
San Antonio, Texas, 78229
Carolyn Paiz, 210-450-8830, paizc@uthscsa.edu
Sarah Horn, MD
About this study
Official title: 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).
Read the 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.
- Being tested
- Pimavanserin, Quetiapine
- Keywords
- quetiapine, pimavanserin, psychosis, hallucinations, delusions
- Medical subject headings
- Lewy Body Disease, Psychotic Disorders, Hallucinations, Delusions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PimavanserinDrug
Also called Nuplazid
Dosage choice and further medication management will be at the discretion of the treating clinician, per routine clinical practice.
QuetiapineDrug
Also called Seroquel
Dosage choice and further medication management will be at the discretion of the treating clinician, per routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| quetiapine | Active comparator | 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. Receives: Drug: Quetiapine |
| pimavanserin | Active comparator | 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. Receives: Drug: Pimavanserin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6 months
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 6 months
Mortality
Number of subjects who survived until the 6 month study assessment visit
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start22 Apr 2022
- Primary completionAug 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's Disease PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Association
- Responsible party
- Sponsor
- Investigators
- Sarah Horn, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590637
- Sponsor's protocol ID
- 22-0198H
- Acronym
- CAMELOT
- Status last verified
- Sep 2025
- First submitted
- 18 Oct 2022
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tran N, Wang CP, Seshadri S, Coss P, Vaou OE, Saadatpour L, Paiz C, Solis D, Grimaldo J, Erskine S, Horn S. Pragmatic trial design enhances diversity and retention among research participants with Lewy body diseases. NPJ Dement. 2026;2(1):10. doi: 10.1038/s44400-026-00059-x. Epub 2026 Feb 2.
PubMed 41640857
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Randomized Trial Comparing Antipsychotics in Lewy Body Disease
- ClinicalTrials.gov ID
- NCT05590637
- Acronym / sponsor ID
- CAMELOT / 22-0198H
- Keywords
- quetiapine, pimavanserin, psychosis, hallucinations, delusions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- Alzheimer's Association
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 21 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| quetiapine | Active comparator | Drug: QuetiapineElderly 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. |
| pimavanserin | Active comparator | Drug: PimavanserinElderly 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Medical contraindication to either medication
- Caregiver unavailable to complete NPI-Q
- Currently taking an antipsychotic medication
- Prescribing provider unwilling to manage either medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PimavanserinAlso: NuplazidDosage choice and further medication management will be at the discretion of the treating clinician, per routine clinical practice. | Drug | pimavanserin |
| QuetiapineAlso: SeroquelDosage choice and further medication management will be at the discretion of the treating clinician, per routine clinical practice. | Drug | quetiapine |
Primary outcome
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.
8 secondary outcomes
Neuropsychiatry Inventory Questionnaire (NPI-Q) total score
Time frame: Baseline to 6 months
Neuropsychiatry Inventory Questionnaire (NPI-Q) (anxiety)
Time frame: Baseline to 6 months
Neuropsychiatry Inventory Questionnaire (NPI-Q) (agitation)
Time frame: Baseline to 6 months
Neuropsychiatry Inventory Questionnaire (NPI-Q) (nighttime behaviors)
Time frame: Baseline to 6 months
Mortality
Time frame: 6 months
Time to discontinuation of per-protocol medication
Time frame: Baseline to 6 months
MDS-UPDRS part 3
Time frame: Baseline to 6 months
CGIC, PGIC, CGI-C:CVR
Time frame: Baseline to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Derived from this study: PubMed 41640857Tran N, Wang CP, Seshadri S, Coss P, Vaou OE, Saadatpour L, Paiz C, Solis D, Grimaldo J, Erskine S, Horn S. Pragmatic trial design enhances diversity and retention among research participants with Lewy body diseases. NPJ Dement. 2026;2(1):10. doi: 10.1038/s44400-026-00059-x. Epub 2026 Feb 2.
- Individual participant dataSharing planned: No
Related trials for Parkinson's Disease Psychosis
Active, not recruitingPhase 2
Clinical Trial Evaluating the Efficacy and Safety of AGB101 for Treatment of Parkinson's Disease Related Psychosis
Parkinson Disease Psychosis
RecruitingPhase 4
Pimavanserin vs. Quetiapine for Treatment of Parkinson's Psychosis
Parkinson's Disease Psychosis
Recruiting
Ultra-High Resolution PET in Aging, Neurodegeneration and Psychotic Disorders
Alzheimer Dementia (AD), ALS - Amyotrophic Lateral Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Horn, MD principal investigator
The University of Texas Health Science Center at San Antonio
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pimavanserin and Quetiapine in people with Parkinson's Disease Psychosis and Dementia With Lewy Bodies, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carolyn Paiz, BS (210-450-8830, paizc@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychiatry Inventory Questionnaire (NPI-Q), Hallucinations + Delusions (H+D) (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05590637, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.