Comparing Antipsychotic Medications in LBD Over Time
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorThe University of Texas Health Science Center at San Antonio
About 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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Medical contraindication to either medication
Caregiver unavailable to complete NPI-Q
Currently taking an antipsychotic medication
Prescribing provider unwilling to manage either medication
Trial design
Design model
Parallel
Treatments tested in this trial
Pimavanserin
DrugDosage choice and further medication management will be at the discretion of the treating clinician, per routine clinical practice.
Quetiapine
DrugDosage choice and further medication management will be at the discretion of the treating clinician, per routine clinical practice.
Treatment groups
94 Participants
are divided into 2 treatment groupsGroup A: quetiapineActive comparator 1 intervention
Group B: pimavanserinActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Neuropsychiatry Inventory Questionnaire (NPI-Q), Hallucinations + Delusions (H+D)
Change in the Hallucinations + Delusions sub-score of the neuropsychiatric inventory questionnaire. Each NPI-Q item is scored by severity (1-3), and distress to caregiver (0-5), then added together (range 0-8) with a higher score indicating greater severity.
Time frame
Baseline to 6 monthsSecondary outcomes
1
Neuropsychiatry Inventory Questionnaire (NPI-Q) total score
Change in the total neuropsychiatric inventory questionnaire score, which includes 12 items, each scored from 0-8 with a higher score indicating more severe symptoms.
Time frame
Baseline to 6 months2
Neuropsychiatry Inventory Questionnaire (NPI-Q) (anxiety)
Change in the neuropsychiatric inventory questionnaire item for anxiety, scored from 0-8 with a higher score indicating more severe anxiety.
Time frame
Baseline to 6 months3
Neuropsychiatry Inventory Questionnaire (NPI-Q) (agitation)
Change in the neuropsychiatric inventory questionnaire for agitation, scored from 0-8 with a higher score indicating more severe agitation.
Time frame
Baseline to 6 months4
Neuropsychiatry Inventory Questionnaire (NPI-Q) (nighttime behaviors)
Change in the neuropsychiatric inventory questionnaire for sleep disturbance, scored from 0-8 with a higher score indicating more severe sleep disturbances.
Time frame
Baseline to 6 monthsOther outcomes
1
Medication out-of-pocket cost
Amount of out of pocket costs spent on medications during the study
Time frame
Baseline to 6 months2
NPI-Q caregiver portion
Change in the total of the caregiver distress items of the neuropsychiatric inventory. The scale contains 12 items, each scored from 0-5 (least to most distress). Possible scores Range from 0-60 with a lower score indicating less caregiver distress
Time frame
Baseline to 6 months3
Patient contact
Number of between visit patient encounters (phone, EMR messages)
Time frame
Baseline to 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Texas Health Science Center at San Antonio
Lead sponsor
Alzheimer's Association
Collaborator
Source ClinicalTrials.gov