Antipsychotics for Lewy Body Disease

(CAMELOT Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Sarah Horn

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: The University of Texas Health Science Center at San Antonio

Must be taking: Antipsychotics

Must not be taking: Antipsychotics

Disqualifiers: Caregiver unavailable, others

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

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).

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. ^{1 2 3 4 5}

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. ^{1 4 5 6 7}

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. ^{1 4 5 8 9}

Research Team

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

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.

Trial 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 (Atypical Antipsychotic)
• Quetiapine (Atypical Antipsychotic)

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

Group I: pimavanserin Active Control 1 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: quetiapine Active Control 1 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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University Health System San Antonio, TX

UT Health Science Center - San Antonio San Antonio, TX

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Patients Recruited

92,500+

Alzheimer's Association

Collaborator

Trials

103

Patients Recruited

44,300+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pimavanserin Use in Lewy Body Dementia: A Case Report Demonstrating the Medication's Efficacy. Baker, M., Song, W., Fusick, A.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of psychosis in Parkinson's disease and dementia with Lewy Bodies: A review. Kyle, K., Bronstein, JM.[2021]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroleptic Sensitivity in Dementia with Lewy Body and Use of Pimavanserin in an Inpatient Setting: A Case Report. Abadir, A., Dalton, R., Zheng, W., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lewy body dementia: the litmus test for neuroleptic sensitivity and extrapyramidal symptoms. Baskys, A.[2018]

In a case review of a patient with Alzheimer's and Lewy body dementia, stopping risperidone led to serious psychiatric symptoms, highlighting the importance of careful medication management in dementia patients.

The healthcare team opted for quetiapine due to its short half-life and low anticholinergic effects, demonstrating a collaborative approach to resolving potential drug-related issues in a patient with complex needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Medication review for dementia patients]. Jahns, KP., Kilimann, I., Ritter, CA., et al.[2012]

Pimavanserin (PIM) treatment for Parkinson's Disease Psychosis (PDP) is associated with significantly lower rates of all-cause hospitalizations and psychiatric-related inpatient hospitalizations compared to quetiapine (QUE), suggesting it may be a safer option for managing PDP.

In a study of over 8,000 patients, those on PIM had a 22% reduction in all-cause hospitalizations and a 37% reduction in psychiatric-related hospitalizations, indicating its potential efficacy in reducing healthcare resource utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients treated with pimavanserin or quetiapine for Parkinson's disease psychosis: analysis of health resource utilization patterns among Medicare beneficiaries. Rajagopalan, K., Rashid, N., Doshi, D.[2023]

In a case series of 4 male patients with dementia with Lewy bodies (DLB), pimavanserin was well-tolerated and led to significant improvements in psychosis symptoms, such as hallucinations and delusions, after other treatments failed.

All patients had previously tried cholinesterase inhibitors and traditional antipsychotics without success, highlighting pimavanserin's potential as an effective alternative for managing psychosis in DLB.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pimavanserin Treatment for Psychosis in Patients with Dementia with Lewy Bodies: A Case Series. Rothenberg, KG., McRae, SG., Dominguez-Colman, LM., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clozapine use in diffuse Lewy body disease. Chacko, RC., Hurley, RA., Jankovic, J.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

Pimavanserin Use in Lewy Body Dementia: A Case Report Demonstrating the Medication's Efficacy. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Quetiapine treatment of psychotic symptoms and aggressive behavior in patients with dementia with Lewy bodies: a case series. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Treatment of psychosis in Parkinson's disease and dementia with Lewy Bodies: A review. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Neuroleptic Sensitivity in Dementia with Lewy Body and Use of Pimavanserin in an Inpatient Setting: A Case Report. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Lewy body dementia: the litmus test for neuroleptic sensitivity and extrapyramidal symptoms. [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

[Medication review for dementia patients]. [2012]

7. England pubmed.ncbi.nlm.nih.gov

Patients treated with pimavanserin or quetiapine for Parkinson's disease psychosis: analysis of health resource utilization patterns among Medicare beneficiaries. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Pimavanserin Treatment for Psychosis in Patients with Dementia with Lewy Bodies: A Case Series. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Clozapine use in diffuse Lewy body disease. [2013]