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Which antipsychotic works best for lewy body psychosis? new trial aims to find out

NCT ID NCT05590637

Symptom relief Sponsor: The University of Texas Health Science Center at San Antonio Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study compares two antipsychotic drugs, pimavanserin and quetiapine, to see which one better reduces hallucinations and delusions in people with Parkinson's disease or dementia with Lewy bodies. About 94 participants will be randomly assigned to one of the two medications, and their symptoms will be tracked using a standard questionnaire. The goal is to provide real-world guidance for doctors choosing between these treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pimavanserin (Nuplazid) and quetiapine (Seroquel)
What this could lead to
If it works, this could help doctors choose the best antipsychotic for managing hallucinations and delusions in people with Lewy body disease.
What could go wrong
This is a small, early-phase trial with only 94 participants, so results may not apply to everyone. Both drugs have known side effects, and the study compares existing treatments, not a new breakthrough.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 94 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2022

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * Medical contraindication to either medication * Caregiver unavailable to complete NPI-Q * Currently taking an antipsychotic medication * Prescribing provider unwilling to manage either medication

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Conditions

The condition(s) this trial relates to.

Delusions Hallucinations Lewy body dementia Lewy Body Disease Psychotic Disorders

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dementia with lewy bodies Parkinson's disease psychosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UT Health Science Center - San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • University Health System

    RECRUITING

    San Antonio, Texas, 78229, United States

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