Compare pimavanserin and quetiapine effectiveness
- Trial ID
- NCT05590637
- Official Title
- A Pragmatic Randomized Trial Comparing Antipsychotics in Lewy Body Disease
- Goal
- Compare pimavanserin and quetiapine effectiveness
- Phase
- PHASE4
- Status
- RECRUITING
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Study Type
- INTERVENTIONAL
- Enrollment
- 94 participants
- Conditions
- Parkinson's Disease Psychosis, Dementia With Lewy Bodies
- Interventions
- Pimavanserin, Quetiapine
Summary For Families
They're comparing two antipsychotics to see which better controls hallucinations and delusions in people with Parkinson's disease psychosis or dementia with Lewy bodies, while keeping an eye on safety and effects on movement. One drug, pimavanserin, blocks serotonin 5‑HT2A receptors and treats psychosis without blocking dopamine receptors, so it is less likely to worsen Parkinsonian movement or interfere with levodopa; the other, quetiapine, is an atypical antipsychotic that blocks dopamine and serotonin receptors, which can calm psychosis but may cause sedation or motor side effects. The trial enrolls neurology clinic patients at UT Health San Antonio who have PD psychosis or DLB and need to start an antipsychotic, are not already on one, have a caregiver able to complete symptom questionnaires, and have a prescriber comfortable prescribing and managing either medication.
Locations
- University Health System, San Antonio, Texas, United States
- UT Health Science Center - San Antonio, San Antonio, Texas, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Pimavanserin. They're comparing two antipsychotics to see which better controls hallucinations and delusions in people with Parkinson's disease psychosis or dementia with Lewy bodies, while keeping an eye on safety and effects on movement. One drug, pimavanserin, blocks serotonin 5‑HT2A receptors and treats psychosis without blocking dopamine receptors, so it is less likely to worsen Parkinsonian movement or interfere with levodopa; the other, quetiapine, is an atypical antipsychotic that blocks dopamine and serotonin receptors, which can calm psychosis but may cause sedation or motor side effects. The trial enrolls neurology clinic patients at UT Health San Antonio who have PD psychosis or DLB and need to start an antipsychotic, are not already on one, have a caregiver able to complete symptom questionnaires, and have a prescriber comfortable prescribing and managing either medication.
- Who can participate?
- Eligibility criteria vary. Check the full listing on ClinicalTrials.gov for detailed inclusion and exclusion criteria.
- Where is this trial located?
- This trial is recruiting at 2 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 4 trial is estimated to last approximately 4 years and 3 months.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.