A Pragmatic Randomized Trial Comparing Antipsychotics in Lewy Body Disease
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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).
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• Patients seen in the neurology clinic at UT Health San Antonio
• Diagnosed with psychosis due to PD or DLB
• Requiring initiation of an antipsychotic medication
• Clinical equipoise between quetiapine and pimavanserin must exist
• The prescribing provider must be comfortable prescribing and managing both quetiapine and pimavanserin
Locations
United States
Texas
University Health System
RECRUITING
San Antonio
UT Health Science Center - San Antonio
RECRUITING
San Antonio
Contact Information
Primary
Carolyn Paiz, BS
paizc@uthscsa.edu
210-450-8830
Time Frame
Start Date: 2022-04-22
Estimated Completion Date: 2027-02
Participants
Target number of participants: 94
Treatments
Active_comparator: quetiapine
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.
Active_comparator: pimavanserin
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.
Related Therapeutic Areas
Sponsors
Collaborators: Alzheimer's Association
Leads: The University of Texas Health Science Center at San Antonio