quetiapine for Dementia
Phase-Based Progress Estimates
Effectiveness
Safety
Dementia+5 More
Pimavanserin - DrugEligibility
Any Age
All Sexes
What conditions do you have?
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Eligibility
Any Age
All Sexes
What conditions do you have?
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Study Summary
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).
Eligible Conditions
- Dementia
- Parkinson's Disease Psychosis
Treatment Effectiveness
Effectiveness Progress
This is further along than 93% of similar trials
Study Objectives
1 Primary · 8 Secondary · Reporting Duration: 6 months
6 months
Mortality
Baseline to 6 months
CGIC, PGIC, CGI-C:CVR
MDS-UPDRS part 3
Pharmaceutical Preparations
NPI-Q caregiver portion
Neuropsychiatry Inventory Questionnaire (NPI-Q) (agitation)
Anxiety
Neuropsychiatry Inventory Questionnaire (NPI-Q) (nighttime behaviors)
Neuropsychiatry Inventory Questionnaire (NPI-Q) total score
Delusions
Patient contact
Pharmaceutical Preparations
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
quetiapine
1 of 2
pimavanserin
1 of 2
Active Control
94 Total Participants · 2 Treatment Groups
Primary Treatment: quetiapine · No Placebo Group · Phase 4
quetiapine
Drug
ActiveComparator Group · 1 Intervention: Quetiapine · Intervention Types: Drugpimavanserin
Drug
ActiveComparator Group · 1 Intervention: Pimavanserin · Intervention Types: DrugTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
Who is running the clinical trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
393 Previous Clinical Trials
74,895 Total Patients Enrolled
5 Trials studying Dementia
715 Patients Enrolled for Dementia
Alzheimer's AssociationOTHER
83 Previous Clinical Trials
37,583 Total Patients Enrolled
27 Trials studying Dementia
29,399 Patients Enrolled for Dementia
Sarah Horn, MDPrincipal InvestigatorUniversity of Texas Health Science Center San Antonio
Eligibility Criteria
Age Any Age · All Participants · 5 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:The prescribing provider must be comfortable prescribing and managing both quetiapine and pimavanserin.
You have been diagnosed with psychosis due to Parkinson's disease or dementia with Lewy bodies.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
Who else is applying?
What state do they live in?
| Louisiana | 100.0% |
How old are they?
| 65+ | 100.0% |
What site did they apply to?
| UT Health Science Center - San Antonio | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
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