Pragmatic trial design enhances diversity and retention among research participants with Lewy body diseases.
Nghi Tran, Chen-Pin Wang, Sudha Seshadri...
https://pubmed.ncbi.nlm.nih.gov/41640857/Actively Recruiting
Led by The University of Texas Health Science Center at San Antonio · Updated on 2025-09-09
94
Participants Needed
2
Research Sites
26 weeks
Total Duration
Psychosis, including hallucinations and delusions, is common in Parkinsons disease PD and dementia with Lewy bodies DLB, collectively called Lewy body disease LBD. These disorders cause movement, cognitive, and psychiatric symptoms, with psychosis affecting up to 60% of people with PD. This research aims to compare the effects of two antipsychotic medications, pimavanserin and quetiapine, in treating psychosis in LBD patients in a routine clinical setting. Participants will be randomly assigned to receive either pimavanserin or quetiapine. Both medications are atypical antipsychotics used to manage psychosis symptoms, with pimavanserin specifically indicated for hallucinations and delusions in Parkinsons disease and quetiapine commonly used for dementia-related psychosis. Dosage and medication management will follow routine clinical practice under the prescribing clinicians discretion. During the study, participants will be assessed for changes in psychosis symptoms over a six-month period using the Neuropsychiatry Inventory Questionnaire NPI-Q focusing on hallucinations and delusions. Additional evaluations include overall NPI-Q scores, anxiety, agitation, nighttime behaviors, mortality, medication discontinuation time, motor function assessments, and global impression scales. The study is designed to monitor participants closely over this timeframe to understand the comparative effects of these medications on psychosis in LBD.
CONDITIONS
Comparing Antipsychotic Medications in LBD Over Time
C
Carolyn Paiz, BS
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The University of Texas Health Science Center at San Antonio
Lead Sponsor
Alzheimer's Association
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Pimavanserin (investigational) | Quetiapine (investigational) |
|---|---|---|
| What it is | An investigational antipsychotic being evaluated for psychosis in Lewy body dementias | An active comparator antipsychotic being evaluated for psychosis in Lewy body dementias |
| Role in trial | One of two randomized treatment arms | One of two randomized treatment arms |
| Primary use | Being studied to reduce hallucinations and delusions in Lewy body disease psychosis over 6 months | Being studied to reduce hallucinations and delusions in Lewy body disease psychosis over 6 months |
| How it is given or performed | Given under clinician discretion per routine practice | Given under clinician discretion per routine practice |
| Evidence status | Evidence from external guidelines supports pimavanserin as a first‑line option for PDP with established safety and efficacy | Used off‑label with limited evidence and mixed results on efficacy |
| Important risks | May prolong QT interval and requires ECG monitoring | May cause somnolence, hypotension, motor or cognitive worsening |
| Important limitations | Relative lack of long‑term data in dementia with Lewy bodies-specific populations | Weak evidence base and unclear efficacy in randomized trials |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive either pimavanserin or quetiapine to treat psychosis associated with Parkinson's disease or dementia with Lewy bodies. Medication management is done as part of routine clinical care.
Visits as determined by treating clinicians per routine clinical practice
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Nghi Tran, Chen-Pin Wang, Sudha Seshadri...
https://pubmed.ncbi.nlm.nih.gov/41640857/The University of Texas Health Science Center at San Antonio
Lead Sponsor
Alzheimer's Association
Collaborating Sponsor