A Phase 4 interventional study of Pimavanserin and Quetiapine in Parkinson's Disease Psychosis and Dementia With Lewy Bodies, sponsored by The University of Texas Health Science Center at San Antonio. Recruiting at 2 sites in United States. Per ClinicalTrials.gov, last updated 2025-09-09.
Sponsored by The University of Texas Health Science Center at San Antonio · Phase 4, Interventional, and Treatment
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).
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.
239 studies on the registry are indexed under Lewy Body Disease; 89 are open to participants now.
This study's planned enrollment of 94 is close to the median of 89 across 152 interventional studies indexed under Lewy Body Disease.
Browse Lewy Body Disease studies →The University of Texas Health Science Center at San Antonio is the lead sponsor of 445 studies on the registry; 89 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 35 (54%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Also known as: Nuplazid
Dosage choice and further medication management will be at the discretion of the treating clinician, per routine clinical practice.
Also known as: Seroquel
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.
Time frame: Baseline to 6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 6 months
Mortality
Number of subjects who survived until the 6 month study assessment visit
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 6 months
Medication out-of-pocket cost
Amount of out of pocket costs spent on medications during the study
Time frame: 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
Time frame: Baseline to 6 months
Patient contact
Number of between visit patient encounters (phone, EMR messages)
Time frame: Baseline to 6 months
Plan to share: No
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Studies of the drugs tested here: Pimavanserin · Quetiapine
The University of Texas Health Science Center at San Antonio →