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Could this pill ease Alzheimer's hallucinations?

NCT ID NCT06126224

Symptom relief Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 04, 2026 · Updated 5 times

Summary

This Phase 3 trial tests whether the drug KarXT can safely reduce psychosis (hallucinations and delusions) in people with Alzheimer's disease. About 500 participants aged 55 to 90 with mild to severe Alzheimer's and moderate to severe psychosis will receive either KarXT or a placebo. The study is double-blind, meaning neither participants nor doctors know who gets the real drug.

What this could mean

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

Active substance
KarXT (a combination of xanomeline and trospium)
What this could lead to
If it works, this could provide a new treatment option to reduce hallucinations and delusions in people with Alzheimer's disease.
What could go wrong
This is an early Phase 3 trial, so results are not yet proven. The drug may not work better than a placebo, and side effects are possible.

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 500 people

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

Started

Aug 2023

Expected to finish

Dec 2026

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.

Key Inclusion Criteria: 1. Is a male or female aged 55 to 90 years, inclusive, at Screening. 2. Can understand the nature of the trial and protocol requirements and provide informed consent or assent before any study assessments are performed. 3. Meets clinical criteria for Possible AD or Probable AD. 4. 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, e.g., major stroke, neoplasm, subdural hematoma. If not available, a non-contrast brain MRI or non-contrast head CT must be done during Screening. 5. Living at the same home or residential assisted-living facility for a minimum of 6 weeks before Screening. 6. Have an identified study partner who should have daily contact (approximately 10 hours a week or more). 7. History of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months prior to Screening. 8. CGI-S scale with a score ≥ 4 at Screening and Baseline. 9. AD subjects are required to have NPI-C: Hallucinations and Delusions (H+D) score of ≥ 6 AND meet at least 1 of the following criteria at Screening and Baseline: 1. Moderate to severe delusions, defined as NPI-C: Delusions domain score of ≥ 2 on 2 of the 8 items OR 2. Moderate to severe hallucinations, defined as NPI-C: Hallucinations domain score of ≥ 2 on 2 of the 7 items 10. MMSE score of 8 to 22, inclusive, at Screening. Key Exclusion Criteria: 1. Psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia. 2. History of major depressive episode with psychotic features during the 12 months prior to Screening. 3. History of bipolar disorder, schizophrenia, or schizoaffective disorder. 4. Significant or severe medical conditions including pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, cardiovascular, or oncologic disease or any other condition that, in the opinion of the Investigator, could jeopardize the safety of the subject, ability to complete or comply with the study procedures or validity of the study results. 5. History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator. 6. Prior exposure to KarXT. 7. History of hypersensitivity to KarXT excipients or trospium chloride. 8. Experienced any significant adverse events (AEs) due to trospium. 9. Participation in another clinical study in which the subject received an experimental or investigational drug within 3 months before Screening or has participated in more than 2 clinical studies in the 12 months prior to Screening. 10. Other protocol-defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease

As listed by the trial registrant

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

Psychosis associated with Alzheimer's disease

How to take part

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

  1. The places running it

    7 sites in 3 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

  • Biomedica Research Group

    RECRUITING

    Providencia, Santiago Metropolitan, 7500000, Chile

  • Health Synergy Clinical Research,LLC - Stuart

    RECRUITING

    Stuart, Florida, 34994, United States

  • Local Institution - 0150

    ACTIVE_NOT_RECRUITING

    Homestead, Florida, 33032-8187, United States

  • Local Institution - 1007

    ACTIVE_NOT_RECRUITING

    Walnut Creek, California, 94596, United States

  • Local Institution - 1009

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33155, United States

  • Local Institution - 1039

    ACTIVE_NOT_RECRUITING

    Maitland, Florida, 32751-5669, United States

  • Local Institution - 1040

    WITHDRAWN

    The Villages, Florida, 32159-8986, United States

  • Local Institution - 1041

    ACTIVE_NOT_RECRUITING

    Tampa, Florida, 33607-4629, United States

  • Local Institution - 1044

    ACTIVE_NOT_RECRUITING

    Phoenix, Arizona, 85012-2836, United States

  • Local Institution - 1102

    COMPLETED

    Miami Lakes, Florida, 33014-6435, United States

  • Local Institution - 1103

    ACTIVE_NOT_RECRUITING

    Sherman Oaks, California, 91403-2131, United States

  • Local Institution - 1104

    ACTIVE_NOT_RECRUITING

    Anaheim, California, 92805-5854, United States

  • Local Institution - 1105

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33179-2537, United States

  • Local Institution - 1106

    RECRUITING

    Cypress, Texas, 77429-6070, United States

  • Local Institution - 1107

    ACTIVE_NOT_RECRUITING

    Hialeah, Florida, 33012-3618, United States

  • Local Institution - 1108

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33133-4231, United States

  • Local Institution - 1109

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33174-2950, United States

  • Local Institution - 1110

    ACTIVE_NOT_RECRUITING

    Tampa, Florida, 33629-5837, United States

  • Local Institution - 1111

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33126-5683, United States

  • Local Institution - 1112

    ACTIVE_NOT_RECRUITING

    Orlando, Florida, 32807-3555, United States

  • Local Institution - 1113

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33155-6630, United States

  • Local Institution - 1114

    ACTIVE_NOT_RECRUITING

    Marrero, Louisiana, 70072-3083, United States

  • Local Institution - 1115

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33135, United States

  • Local Institution - 1116

    ACTIVE_NOT_RECRUITING

    Chandler, Arizona, 85286, United States

  • Local Institution - 1117

    ACTIVE_NOT_RECRUITING

    Los Alamitos, California, 90720-6506, United States

  • Local Institution - 1118

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33122-1721, United States

  • Local Institution - 1119

    ACTIVE_NOT_RECRUITING

    Canoga Park, California, 91303-1844, United States

  • Local Institution - 1120

    ACTIVE_NOT_RECRUITING

    Hialeah, Florida, 33012-4648, United States

  • Local Institution - 1121

    WITHDRAWN

    Red Oak, Texas, 75154, United States

  • Local Institution - 1122

    ACTIVE_NOT_RECRUITING

    Dayton, Ohio, 45459-4248, United States

  • Local Institution - 1123

    COMPLETED

    Tampa, Florida, 33614-2869, United States

  • Local Institution - 1124

    ACTIVE_NOT_RECRUITING

    Tampa, Florida, 33614-2700, United States

  • Local Institution - 1125

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33135-1601, United States

  • Local Institution - 1126

    COMPLETED

    Miami Gardens, Florida, 33056-4000, United States

  • Local Institution - 1127

    ACTIVE_NOT_RECRUITING

    Largo, Florida, 33777-1359, United States

  • Local Institution - 1129

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33165-3947, United States

  • Local Institution - 1131

    RECRUITING

    Viera, Florida, 32940, United States

  • Local Institution - 1132

    ACTIVE_NOT_RECRUITING

    Flowood, Mississippi, 39232, United States

  • Local Institution - 1133

    ACTIVE_NOT_RECRUITING

    Sweetwater, Florida, 33182, United States

  • Local Institution - 1134

    ACTIVE_NOT_RECRUITING

    Stafford, Texas, 77477-3929, United States

  • Local Institution - 1135

    WITHDRAWN

    Port Jefferson Station, New York, 11776-3386, United States

  • Local Institution - 1136

    ACTIVE_NOT_RECRUITING

    Orlando, Florida, 32806-1041, United States

  • Local Institution - 1137

    ACTIVE_NOT_RECRUITING

    Port Orange, Florida, 32127-2914, United States

  • Local Institution - 1138

    ACTIVE_NOT_RECRUITING

    Cutler Bay, Florida, 33189-1230, United States

  • Local Institution - 1139

    ACTIVE_NOT_RECRUITING

    Rochester Hills, Michigan, 48307-2760, United States

  • Local Institution - 1140

    ACTIVE_NOT_RECRUITING

    Hialeah, Florida, 33016-1814, United States

  • Local Institution - 1141

    WITHDRAWN

    Columbus, Georgia, 31909-1693, United States

  • Local Institution - 1142

    ACTIVE_NOT_RECRUITING

    Lancaster, California, 93534-2839, United States

  • Local Institution - 1143

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33145-2455, United States

  • Local Institution - 1144

    WITHDRAWN

    Las Vegas, Nevada, 89106-4145, United States

  • Local Institution - 1145

    ACTIVE_NOT_RECRUITING

    Homestead, Florida, 33032-8187, United States

  • Local Institution - 1146

    ACTIVE_NOT_RECRUITING

    Maitland, Florida, 32751-6138, United States

  • Local Institution - 1147

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33176-7947, United States

  • Local Institution - 1148

    ACTIVE_NOT_RECRUITING

    Elgin, Illinois, 60123-9215, United States

  • Local Institution - 1149

    WITHDRAWN

    Malvern, Pennsylvania, 19355-3267, United States

  • Local Institution - 1150

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33165, United States

  • Local Institution - 1151

    ACTIVE_NOT_RECRUITING

    Encino, California, 91316, United States

  • Local Institution - 1152

    WITHDRAWN

    Augusta, Georgia, 30912-0020, United States

  • Local Institution - 1153

    WITHDRAWN

    New Hyde Park, New York, 11042-2062, United States

  • Local Institution - 1154

    ACTIVE_NOT_RECRUITING

    Katy, Texas, 77450-1759, United States

  • Local Institution - 1155

    ACTIVE_NOT_RECRUITING

    Hialeah, Florida, 33012-3158, United States

  • Local Institution - 1156

    ACTIVE_NOT_RECRUITING

    Clermont, Florida, 34711-5190, United States

  • Local Institution - 1157

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33184-1412, United States

  • Local Institution - 1158

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33175, United States

  • Local Institution - 1159

    ACTIVE_NOT_RECRUITING

    Miami, Florida, 33032, United States

  • Local Institution - 1160

    WITHDRAWN

    Apopka, Florida, 32703-5835, United States

  • Local Institution - 1161

    ACTIVE_NOT_RECRUITING

    Decatur, Georgia, 30030, United States

  • Local Institution - 1162

    ACTIVE_NOT_RECRUITING

    Delray Beach, Florida, 33445-2581, United States

  • Local Institution - 1163

    ACTIVE_NOT_RECRUITING

    Houston, Texas, 77074-2085, United States

  • Local Institution - 1164

    ACTIVE_NOT_RECRUITING

    Doral, Florida, 33122-1620, United States

  • Local Institution - 1165

    ACTIVE_NOT_RECRUITING

    Fort Myers, Florida, 33912-4302, United States

  • Local Institution - 1501

    ACTIVE_NOT_RECRUITING

    Culiacán, Sinaloa, 80020, Mexico

  • Local Institution - 1502

    ACTIVE_NOT_RECRUITING

    Saltillo Centro, Coahuila, 25000, Mexico

  • Local Institution - 1503

    ACTIVE_NOT_RECRUITING

    Monterrey, Nuevo León, 64460, Mexico

  • Local Institution - 1504

    WITHDRAWN

    Zona Urbana Río Tijuana, Estado de Baja California, 22010, Mexico

  • Local Institution - 1505

    ACTIVE_NOT_RECRUITING

    Monterrey, Nuevo León, 64620, Mexico

  • Local Institution - 1506

    ACTIVE_NOT_RECRUITING

    México, 03100, Mexico

  • Local Institution - 1507

    WITHDRAWN

    Zapopan, Jalisco, 45170, Mexico

  • Local Institution - 1601

    WITHDRAWN

    Verdun, Quebec, H4H 1R3, Canada

  • Local Institution - 1602

    WITHDRAWN

    Toronto, Ontario, M5B 1W8, Canada

  • Local Institution - 1603

    WITHDRAWN

    Hamilton, Ontario, ON L8M 1W9, Canada

  • Local Institution - 1604

    WITHDRAWN

    Whitby, Ontario, L1N 5S9, Canada

  • Local Institution - 1605

    WITHDRAWN

    Calgary, Alberta, T2N 1N4, Canada

  • Local Institution - 1606

    WITHDRAWN

    Montreal, Quebec, H4H 1R3, Canada

  • Local Institution - 2101

    WITHDRAWN

    London, Surrey, SE5 8AZ, United Kingdom

  • Local Institution - 2104

    WITHDRAWN

    Motherwell, ML1 4UF, United Kingdom

  • Local Institution - 2105

    WITHDRAWN

    Aberdeen, AB25 2ZL, United Kingdom

  • Local Institution - 2106

    WITHDRAWN

    Leeds, LS7 3JX, United Kingdom

  • Local Institution - 2107

    WITHDRAWN

    Sheffield, SouthYorkshire, s5 7JT, United Kingdom

  • Local Institution - 2108

    WITHDRAWN

    Swinton, Greater Manchester, M27 8FF, United Kingdom

  • Local Institution - 2109

    WITHDRAWN

    Chertsey, KT16 9AU, United Kingdom

  • Local Institution - 2110

    WITHDRAWN

    Ilford, Greater London, IG1 4HP, United Kingdom

  • Local Institution - 2111

    WITHDRAWN

    Preston, PR2 9HT, United Kingdom

  • Local Institution - 2112

    WITHDRAWN

    Edinburgh, EH4 2XU, United Kingdom

  • Local Institution - 2801

    ACTIVE_NOT_RECRUITING

    Hasselt, Limburg, 3500, Belgium

  • Local Institution - 2802

    ACTIVE_NOT_RECRUITING

    Leuven, Vlaams Brabant, 3000, Belgium

  • Local Institution - 2803

    ACTIVE_NOT_RECRUITING

    Roeselare, West-Vlaanderen, 8800, Belgium

  • Local Institution - 2901

    WITHDRAWN

    Geneva, Genève (fr), CH-1205, Switzerland

  • Local Institution - 2902

    WITHDRAWN

    Lausanne, Vaud (fr), 1011, Switzerland

  • Local Institution - 4201

    ACTIVE_NOT_RECRUITING

    Ścinawa, 59-330, Poland

  • Local Institution - 4202

    ACTIVE_NOT_RECRUITING

    Lodz, 90-227, Poland

  • Local Institution - 4203

    WITHDRAWN

    Sopot, Pomeranian Voivodeship, 81-855, Poland

  • Local Institution - 4204

    ACTIVE_NOT_RECRUITING

    Bydgoszcz, 85-080, Poland

  • Local Institution - 4205

    ACTIVE_NOT_RECRUITING

    Katowice, 40-282, Poland

  • Local Institution - 4206

    ACTIVE_NOT_RECRUITING

    Lublin, Lublin Voivodeship, 20-064, Poland

  • Local Institution - 4207

    ACTIVE_NOT_RECRUITING

    Lodz, Lódzkie, 90-349, Poland

  • Local Institution - 4208

    COMPLETED

    Katowice, Silesian Voivodeship, 40-156, Poland

  • Local Institution - 4209

    WITHDRAWN

    Siemianowice Śląskie, 41-100, Poland

  • Local Institution - 4601

    ACTIVE_NOT_RECRUITING

    Pécs, Baranya, 7633, Hungary

  • Local Institution - 4602

    ACTIVE_NOT_RECRUITING

    Budapest, 1083, Hungary

  • Local Institution - 4603

    ACTIVE_NOT_RECRUITING

    Miskolc, 3526, Hungary

  • Local Institution - 4701

    ACTIVE_NOT_RECRUITING

    Eskişehir, 26040, Turkey (Türkiye)

  • Local Institution - 4702

    ACTIVE_NOT_RECRUITING

    Atakum, Samsun, 55270, Turkey (Türkiye)

  • Local Institution - 4703

    ACTIVE_NOT_RECRUITING

    Izmir, 35575, Turkey (Türkiye)

  • Local Institution - 4704

    ACTIVE_NOT_RECRUITING

    Istanbul, 34093, Turkey (Türkiye)

  • Local Institution - 4705

    ACTIVE_NOT_RECRUITING

    Izmir, 35210, Turkey (Türkiye)

  • Local Institution - 4801

    ACTIVE_NOT_RECRUITING

    Heraklion, 71110, Greece

  • Local Institution - 4802

    ACTIVE_NOT_RECRUITING

    Chaidari, Athens, Attica, 124 62, Greece

  • Local Institution - 4803

    ACTIVE_NOT_RECRUITING

    Athens, Attica, 115 26, Greece

  • Local Institution - 4805

    ACTIVE_NOT_RECRUITING

    Athens, Attica, 115 21, Greece

  • Local Institution - 4806

    ACTIVE_NOT_RECRUITING

    Marousi, Attica, 151 23, Greece

  • Local Institution - 6001

    RECRUITING

    Las Condes, 7550000, Chile

  • Local Institution - 6101

    WITHDRAWN

    Callao, Callao 2, Peru

  • Local Institution - 6102

    WITHDRAWN

    Miraflores, Lima region, 15046, Peru

  • Local Institution - 6103

    ACTIVE_NOT_RECRUITING

    Pueblo Libre, Lima region, 15084, Peru

  • Local Institution - 7001

    COMPLETED

    Shanghai, Shanghai Municipality, 200030, China

  • Local Institution - 7002

    ACTIVE_NOT_RECRUITING

    Chengdu, Sichuan, 610000, China

  • Local Institution - 7003

    ACTIVE_NOT_RECRUITING

    Shenzhen, Guangdong, 518118, China

  • Local Institution - 7004

    COMPLETED

    Beijing, Beijing Municipality, 100025, China

  • Local Institution - 7005

    ACTIVE_NOT_RECRUITING

    Beijing, Beijing Municipality, 100088, China

  • Local Institution - 7006

    COMPLETED

    Hangzhou, Zhejiang, 310014, China

  • Local Institution - 7007

    ACTIVE_NOT_RECRUITING

    Hefei, Anhui, 230022, China

  • Local Institution - 7008

    COMPLETED

    Guangzhou, Guangdong, 0, China

  • Local Institution - 7009

    ACTIVE_NOT_RECRUITING

    Guangzhou, Guangdong, 510260, China

  • Local Institution - 7010

    ACTIVE_NOT_RECRUITING

    Hangzhou, Zhejiang, 310013, China

  • Local Institution - 7012

    ACTIVE_NOT_RECRUITING

    Nanchang, Jiangxi, 330008, China

  • Local Institution - 7013

    COMPLETED

    Nanjing, Jiangsu, 210011, China

  • Local Institution - 7014

    WITHDRAWN

    Nanjing, Jiangsu, 210009, China

  • Local Institution - 7015

    ACTIVE_NOT_RECRUITING

    Chongqing, Chongqing Municipality, 400016, China

  • Local Institution - 7016

    ACTIVE_NOT_RECRUITING

    Guangzhou, Guangdong, 510120, China

  • Local Institution - 7017

    ACTIVE_NOT_RECRUITING

    Hangzhou, Zhejiang, 310003, China

  • Local Institution - 7018

    ACTIVE_NOT_RECRUITING

    Wenzhou, Zhejiang, 325000, China

  • Local Institution - 7019

    COMPLETED

    Tianjin, Tianjin Municipality, 300222, China

  • Local Institution - 7020

    COMPLETED

    Hangzhou, Zhejiang, 310009, China

  • Local Institution - 7201

    ACTIVE_NOT_RECRUITING

    Seoul, 143-729, South Korea

  • Local Institution - 7202

    ACTIVE_NOT_RECRUITING

    Seongnam-si, 0, South Korea

  • Local Institution - 7203

    ACTIVE_NOT_RECRUITING

    Seoul, 07071, South Korea

  • Local Institution - 7204

    WITHDRAWN

    Busan, 49201, South Korea

  • Local Institution - 7205

    ACTIVE_NOT_RECRUITING

    Incheon, Incheon Gwang'yeogsi, 21565, South Korea

  • Local Institution - 7206

    COMPLETED

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Local Institution - 7207

    ACTIVE_NOT_RECRUITING

    Seongnam-si, Gyeonggido, 13496, South Korea

  • Local Institution - 7208

    ACTIVE_NOT_RECRUITING

    Buk-gu, Daegu Gwang'yeogsi, 41404, South Korea

  • Psicomed Estudios Medicos

    RECRUITING

    Antofagasta, 1270244, Chile

  • Shanghai General Hospital - North Campus

    RECRUITING

    Shanghai, Shanghai Municipality, 200080, China

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