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Could this pill ease Alzheimer's psychosis? large trial underway

NCT ID NCT06947941

Symptom relief Sponsor: Bristol-Myers Squibb 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 01, 2026 · Updated 4 times

Summary

This Phase 3 trial tests whether the drug combination KarXT + KarX-EC can safely reduce psychosis symptoms (like hallucinations and delusions) in people with Alzheimer's disease. About 325 participants aged 55-90 will receive either the drug or a placebo. The study is currently recruiting.

What this could mean

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

Active substance
KarXT (xanomeline/trospium chloride) plus KarX-EC (xanomeline enteric-coated)
What this could lead to
If successful, this could provide a new treatment option to ease psychosis symptoms like hallucinations and delusions in people with Alzheimer's disease.
What could go wrong
This is an early Phase 3 trial, so results are not guaranteed. The drug may not work better than placebo, and side effects are possible. It is not a cure for Alzheimer's.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 325 people

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

Started

Mar 2026

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

55 to 90 years

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: * Participants must be 55 to 90 years of age, inclusive, at the time of Screening (Visit 1). * Participants must be diagnosed with Alzheimer's disease in accordance with the 2024 revised criteria for diagnosis and staging of Alzheimer's Disease: Alzheimer's Association Workgroup. * Participants must have a magnetic resonance imaging (MRI) or computed tomography (CT) scan of the brain (completed within the past 5 years) taken during or subsequent to the onset of dementia to rule out other central nervous system (CNS) disease that could account for the dementia syndrome, eg, major stroke, neoplasm, subdural hematoma. * Participants must have a history of psychotic symptoms (meeting International Psychogeriatric Association criteria) for at least 2 months prior to Screening (Visit 1) (participants may or may not have symptoms of agitation). Exclusion Criteria: * Participants must not have psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia, eg, schizophrenia, schizoaffective disorder, delusional disorder, or mood disorder with psychotic features. * Participants must not have history of major depressive episode with psychotic features during the 12 months prior to Screening, or history of bipolar disorder, schizophrenia, or schizoaffective disorder. * Participants must not have certain safety concerns, including certain laboratory test irregularities. * Other protocol-defined Inclusion/Exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease dementia psychotic disorder Psychotic Disorders

As listed by the trial registrant

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

Alzheimer 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

    19 sites in 5 countries. 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

  • Gilbert Neurology Partners/CCT Research

    RECRUITING

    Gilbert, Arizona, 85297, United States

  • Inland Psychiatric Medical Group.

    RECRUITING

    Chino, California, 91710, United States

  • Insight Clinical Trials LLC - Independence

    RECRUITING

    Independence, Ohio, 44131, United States

  • Local Institution - 0001

    WITHDRAWN

    Naples, Florida, 34105, United States

  • Local Institution - 0004

    NOT_YET_RECRUITING

    Motherwell, ML1 4UF, United Kingdom

  • Local Institution - 0005

    NOT_YET_RECRUITING

    Exeter, Devon, EX12LU, United Kingdom

  • Local Institution - 0009

    NOT_YET_RECRUITING

    Chertsey, Surrey, KT160PZ, United Kingdom

  • Local Institution - 0015

    WITHDRAWN

    Oxford, Oxfordshire, OX3 7JX, United Kingdom

  • Local Institution - 0017

    NOT_YET_RECRUITING

    Sheffield, Yorkshire and the Humber, S47QQ, United Kingdom

  • Local Institution - 0018

    WITHDRAWN

    Crowborough, TN6 1NY, United Kingdom

  • Local Institution - 0020

    NOT_YET_RECRUITING

    Macquarie Park, New South Wales, 2113, Australia

  • Local Institution - 0023

    NOT_YET_RECRUITING

    London, England, W1G 8TA, United Kingdom

  • Local Institution - 0024

    NOT_YET_RECRUITING

    London, WC1N3BG, United Kingdom

  • Local Institution - 0025

    NOT_YET_RECRUITING

    Montreal, Quebec, H4H 1R3, Canada

  • Local Institution - 0027

    NOT_YET_RECRUITING

    Whitby, Ontario, L1N 5S9, Canada

  • Local Institution - 0029

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44195, United States

  • Local Institution - 0034

    NOT_YET_RECRUITING

    Osaka, 550-0006, Japan

  • Local Institution - 0035

    NOT_YET_RECRUITING

    Nankoku-shi, 783-8505, Japan

  • Local Institution - 0040

    NOT_YET_RECRUITING

    Suita, Osaka, 565-0871, Japan

  • Local Institution - 0052

    NOT_YET_RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Local Institution - 0054

    NOT_YET_RECRUITING

    Toronto, Ontario, M6J1H4, Canada

  • Local Institution - 1401

    NOT_YET_RECRUITING

    Naples, Florida, 34105, United States

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