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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
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
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 moreOther study objectives
Pharmaceutical Preparations
NPI-Q caregiver portion
Patient contact
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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
477 Previous Clinical Trials
92,876 Total Patients Enrolled
5 Trials studying Dementia
2,107 Patients Enrolled for Dementia
Alzheimer's AssociationOTHER
99 Previous Clinical Trials
43,350 Total Patients Enrolled
38 Trials studying Dementia
33,555 Patients Enrolled for Dementia
Sarah Horn, MDPrincipal InvestigatorUniversity of Texas Health Science Center San Antonio
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot take certain medications due to health risks.My doctor is experienced in prescribing and managing quetiapine and pimavanserin.My doctor is not willing to manage my medication.I have been diagnosed with psychosis related to Parkinson's disease or Lewy body dementia.I need to start taking medication for psychosis.I am currently on antipsychotic medication.
Research Study Groups:
This trial has the following groups:- Group 1: pimavanserin
- Group 2: quetiapine
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.