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NCT05590637 · ClinicalTrials.gov registry record · Phase 4
Comparing Antipsychotic Medications in LBD Over Time
A Phase 4 study of Dementia With Lewy Bodies and Parkinson's Disease Psychosis, sponsored by The University of Texas Health Science Center at San Antonio.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 94
- Enrollment target
- 2
- Study locations
NCT05590637: Recruiting Phase 4 study of Dementia With Lewy Bodies and Parkinson's Disease Psychosis, sponsored by The University of Texas Health Science Center at San Antonio.
NCT05590637 is a Phase 4 study of Dementia With Lewy Bodies and Parkinson's Disease Psychosis that is actively recruiting participants, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 94 participants, below the 467-participant average among 22 other Dementia With Lewy Bodies trials with a reported enrollment target (80% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05590637, a Phase 4 study of Dementia With Lewy Bodies and Parkinson's Disease Psychosis, is actively recruiting participants, sponsored by The University of Texas Health Science Center at San Antonio.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 94 participants
- Enrollment target
- 2
- Study locations
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).
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Quetiapine
- DRUG Pimavanserin
Study Locations (2)
Texas
- University Health System - San Antonio
- UT Health Science Center - San Antonio - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2022-04-22 |
| Est. Completion | 2027-02 |
| Phase | Phase 4 |
What NCT05590637 shows while recruiting
NCT05590637 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 467-participant average among 22 other Dementia With Lewy Bodies trials with a reported enrollment target (80% lower).
The record links to 2 conditions, with Dementia With Lewy Bodies appearing as the primary indexed condition, and to 2 interventions - of which Quetiapine is the first listed.
NCT05590637 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05590637 about?
NCT05590637 is a clinical study titled "Comparing Antipsychotic Medications in LBD Over Time". 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 (D...
What is the current status of trial NCT05590637?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 94 participants. The study started on 2022-04-22. Estimated completion is 2027-02.
What conditions does trial NCT05590637 study?
This clinical trial studies the following conditions: Dementia With Lewy Bodies, Parkinson's Disease Psychosis.
What interventions are being tested in trial NCT05590637?
The interventions under investigation include: Quetiapine (DRUG), Pimavanserin (DRUG).
Who is sponsoring clinical trial NCT05590637?
This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05590637 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dementia With Lewy Bodies
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05590637's enrollment target sits among peer trials
94 15th of 22 higher than 8 of 22 other Dementia With Lewy Bodies trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dementia With Lewy Bodies trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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