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Atypical Antipsychotic

Antipsychotics for Lewy Body Disease (CAMELOT Trial)

Phase 4
Recruiting
Led By Sarah Horn, MD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Summary

This trial will compare two drugs to see which works better to reduce hallucinations & delusions caused by PD or DLB (Lewy body disease).

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Pimavanserin may cause swelling of the legs, nausea, and confusion. Quetiapine can lead to drowsiness, weight gain, dry mouth, constipation, or blurred vision. Side effects vary from person to person.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Delusions
Secondary study objectives
CGIC, PGIC, CGI-C:CVR
MDS-UPDRS part 3
Mortality
+5 more
Other study objectives
Pharmaceutical Preparations
NPI-Q caregiver portion
Patient contact

Trial Design

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.

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor
467 Previous Clinical Trials
91,670 Total Patients Enrolled
5 Trials studying Dementia
2,107 Patients Enrolled for Dementia
Alzheimer's AssociationOTHER
95 Previous Clinical Trials
42,206 Total Patients Enrolled
34 Trials studying Dementia
32,561 Patients Enrolled for Dementia
Sarah Horn, MDPrincipal InvestigatorUniversity of Texas Health Science Center San Antonio

Media Library

Pimavanserin (Atypical Antipsychotic) Clinical Trial Eligibility Overview. Trial Name: NCT05590637 — Phase 4
Dementia Research Study Groups: pimavanserin, quetiapine
Dementia Clinical Trial 2023: Pimavanserin Highlights & Side Effects. Trial Name: NCT05590637 — Phase 4
Pimavanserin (Atypical Antipsychotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05590637 — Phase 4
~0 spots leftby Oct 2024