94 Participants Needed

Antipsychotics for Lewy Body Disease

(CAMELOT Trial)

Recruiting at 1 trial location
CP
Overseen ByCarolyn Paiz, BS
Age: Any Age
Sex: Any
Trial Phase: Phase 4
Sponsor: The University of Texas Health Science Center at San Antonio
Must be taking: Antipsychotics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

Trial Summary

Will I have to stop taking my current medications?

If you are currently taking an antipsychotic medication, you will need to stop before joining this trial.

What evidence supports the effectiveness of the drug Pimavanserin for treating psychosis in Lewy Body Disease?

Pimavanserin has been shown to help improve psychotic symptoms in patients with Lewy Body Dementia without worsening motor symptoms, as demonstrated in case reports and its approved use for similar symptoms in Parkinson's disease.12345

Is it safe to use antipsychotics like Pimavanserin and Quetiapine for Lewy Body Disease?

Pimavanserin and Quetiapine are considered safer options for treating psychosis in Lewy Body Disease compared to other antipsychotics, as they are less likely to worsen motor symptoms or cause serious side effects like neuroleptic sensitivity. Pimavanserin is FDA-approved for Parkinson's disease psychosis and has shown potential in Lewy Body Disease, while Quetiapine is noted for reducing psychiatric symptoms without increasing the risk of neuroleptic sensitivity.14567

How is the drug Pimavanserin unique in treating Lewy Body Disease?

Pimavanserin is unique because it treats psychosis in Lewy Body Disease without worsening motor symptoms, unlike many other antipsychotics that can cause severe side effects in these patients. It works by targeting serotonin receptors instead of dopamine, making it a safer option for those with neuroleptic sensitivity.14589

What is the purpose of this trial?

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).

Research Team

SH

Sarah Horn

Principal Investigator

University of Texas Health Science Center San Antonio

Eligibility Criteria

This trial is for individuals with hallucinations or delusions due to Parkinson's disease (PD) or dementia with Lewy bodies (DLB), who need to start antipsychotic treatment. Participants must be seen at the UT Health San Antonio neurology clinic and have a doctor willing to manage both Pimavanserin and Quetiapine treatments.

Inclusion Criteria

Clinical equipoise between quetiapine and pimavanserin must exist
My doctor is experienced in prescribing and managing quetiapine and pimavanserin.
Patients seen in the neurology clinic at UT Health San Antonio
See 2 more

Exclusion Criteria

Caregiver unavailable to complete NPI-Q
I cannot take certain medications due to health risks.
My doctor is not willing to manage my medication.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either quetiapine or pimavanserin to treat psychosis in Lewy body disease

6 months
Regular visits as per clinical practice

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Pimavanserin
  • Quetiapine
Trial Overview The study aims to compare the effectiveness of two antipsychotic medications, Pimavanserin and Quetiapine, in improving psychosis symptoms in patients with Lewy body disease over time when used in routine clinical practice.
Participant Groups
2Treatment groups
Active Control
Group I: pimavanserinActive Control1 Intervention
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.
Group II: quetiapineActive Control1 Intervention
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.

Pimavanserin is already approved in United States for the following indications:

🇺🇸
Approved in United States as Nuplazid for:
  • Hallucinations and delusions associated with Parkinson's disease psychosis

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials
486
Recruited
92,500+

Alzheimer's Association

Collaborator

Trials
103
Recruited
44,300+

Findings from Research

Pimavanserin, an antipsychotic approved for Parkinson's disease psychosis, effectively improved psychotic symptoms in a 75-year-old man with Lewy Body Dementia over a six-week period, without worsening his motor symptoms.
The medication works as a serotonin 2A inverse agonist, suggesting potential for use in other conditions presenting with psychosis, although current literature on off-label uses is limited.
Pimavanserin Use in Lewy Body Dementia: A Case Report Demonstrating the Medication's Efficacy.Baker, M., Song, W., Fusick, A.[2023]
In a study of nine patients with dementia with Lewy bodies, quetiapine treatment led to a positive response in five patients, showing over a 50% reduction in psychotic symptoms and aggressive behavior as measured by the Neuropsychiatric Inventory after 8 weeks.
However, three patients experienced side effects such as somnolence or orthostatic hypotension, leading to withdrawal from the treatment, indicating that while quetiapine may be beneficial for some, it also carries risks that need to be managed.
Quetiapine treatment of psychotic symptoms and aggressive behavior in patients with dementia with Lewy bodies: a case series.Takahashi, H., Yoshida, K., Sugita, T., et al.[2022]
Clozapine is the most effective neuroleptic for treating psychotic symptoms in Parkinson's Disease Dementia (PDD) and Dementia with Lewy Bodies (DLB), but its use is limited due to the risk of agranulocytosis and the need for regular blood monitoring.
Pimavanserin offers a promising alternative for treating Parkinson's Disease Psychosis (PDP) without worsening motor function, although more research is needed to confirm its efficacy and safety in DLB psychosis.
Treatment of psychosis in Parkinson's disease and dementia with Lewy Bodies: A review.Kyle, K., Bronstein, JM.[2021]

References

Pimavanserin Use in Lewy Body Dementia: A Case Report Demonstrating the Medication's Efficacy. [2023]
Quetiapine treatment of psychotic symptoms and aggressive behavior in patients with dementia with Lewy bodies: a case series. [2022]
Treatment of psychosis in Parkinson's disease and dementia with Lewy Bodies: A review. [2021]
Neuroleptic Sensitivity in Dementia with Lewy Body and Use of Pimavanserin in an Inpatient Setting: A Case Report. [2022]
Lewy body dementia: the litmus test for neuroleptic sensitivity and extrapyramidal symptoms. [2018]
[Medication review for dementia patients]. [2012]
Patients treated with pimavanserin or quetiapine for Parkinson's disease psychosis: analysis of health resource utilization patterns among Medicare beneficiaries. [2023]
Pimavanserin Treatment for Psychosis in Patients with Dementia with Lewy Bodies: A Case Series. [2023]
Clozapine use in diffuse Lewy body disease. [2013]
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