Pimavanserin for Parkinson's (NCT05590637)
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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 4 trial is estimated to last approximately 4 years and 3 months.
- 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.
- 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.
- Will I get a placebo in this trial?
- There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.