Psychosis Associated With Alzheimer's DiseasePhase 3NCT06126224

A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)

A Phase 3 study testing KarXT in people with Psychosis Associated With Alzheimer's Disease, run by Karuna Therapeutics, Inc., a Bristol Myers Squibb company at 157 sites in 14 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

This is a Phase 3, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of KarXT in male and female subjects who are aged 55 to 90 years and have mild to severe Alzheimer's Disease (AD) with moderate to severe psychosis related to AD. Read more about this study

Who is it for?: Ages 55 to 90 years
Conditions the study is for: Psychosis Associated With Alzheimer's Disease
What is being tested?: KarXT
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 500 participants
Where: 157 sitesin 14 countries
Study dates: 28 Aug 2023to 9 Dec 2026
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Is a male or female aged 55 to 90 years, inclusive, at Screening.
Can understand the nature of the trial and protocol requirements and provide informed consent or assent before any study assessments are performed.
Meets clinical criteria for Possible AD or Probable AD.
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.
Living at the same home or residential assisted-living facility for a minimum of 6 weeks before Screening.
Have an identified study partner who should have daily contact (approximately 10 hours a week or more).

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History of psychotic symptoms (meeting International Psychogeriatric Association criteria) (Cummings 2020) for at least 2 months prior to Screening.
CGI-S scale with a score ≥ 4 at Screening and Baseline.
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:
Moderate to severe delusions, defined as NPI-C: Delusions domain score of ≥ 2 on 2 of the 8 items OR
Moderate to severe hallucinations, defined as NPI-C: Hallucinations domain score of ≥ 2 on 2 of the 7 items
MMSE score of 8 to 22, inclusive, at Screening.

Who cannot join

Psychotic symptoms that are primarily attributable to a condition other than the AD causing the dementia.
History of major depressive episode with psychotic features during the 12 months prior to Screening.
History of bipolar disorder, schizophrenia, or schizoaffective disorder.
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.
History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator.
Prior exposure to KarXT.

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History of hypersensitivity to KarXT excipients or trospium chloride.
Experienced any significant adverse events (AEs) due to trospium.
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.
Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

157 sites in 14 countries. Contact the study team or a site near you to ask about taking part.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact

855-907-3286

Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #. contact

Country

City, postcode or hospital

Sites recruiting now only

157 sites in 14 countries

United States70 sites, 3 recruiting

Local Institution - 1104
Anaheim, California, 92805-5854
Active, not recruiting
Local Institution - 1160
Apopka, Florida, 32703-5835
Withdrawn
Local Institution - 1152
Augusta, Georgia, 30912-0020
Withdrawn
Local Institution - 1119
Canoga Park, California, 91303-1844
Active, not recruiting
Local Institution - 1116
Chandler, Arizona, 85286
Active, not recruiting
Local Institution - 1156
Clermont, Florida, 34711-5190
Active, not recruiting
Local Institution - 1141
Columbus, Georgia, 31909-1693
Withdrawn
Local Institution - 1138
Cutler Bay, Florida, 33189-1230
Active, not recruiting
Local Institution - 1106
Cypress, Texas, 77429-6070
Site 1106
Recruiting
Local Institution - 1122
Dayton, Ohio, 45459-4248
Completed
Local Institution - 1161
Decatur, Georgia, 30030
Active, not recruiting
Local Institution - 1162
Delray Beach, Florida, 33445-2581
Active, not recruiting
Local Institution - 1164
Doral, Florida, 33122-1620
Active, not recruiting
Local Institution - 1148
Elgin, Illinois, 60123-9215
Active, not recruiting
Local Institution - 1151
Encino, California, 91316
Active, not recruiting
Local Institution - 1132
Flowood, Mississippi, 39232
Active, not recruiting
Local Institution - 1165
Fort Myers, Florida, 33912-4302
Active, not recruiting
Local Institution - 1155
Hialeah, Florida, 33012-3158
Active, not recruiting
Local Institution - 1107
Hialeah, Florida, 33012-3618
Active, not recruiting
Local Institution - 1120
Hialeah, Florida, 33012-4648
Active, not recruiting
Local Institution - 1140
Hialeah, Florida, 33016-1814
Active, not recruiting
Local Institution - 0150
Homestead, Florida, 33032-8187
Active, not recruiting
Local Institution - 1145
Homestead, Florida, 33032-8187
Active, not recruiting
Local Institution - 1163
Houston, Texas, 77074-2085
Active, not recruiting
Local Institution - 1154
Katy, Texas, 77450-1759
Active, not recruiting
Local Institution - 1142
Lancaster, California, 93534-2839
Active, not recruiting
Local Institution - 1127
Largo, Florida, 33777-1359
Active, not recruiting
Local Institution - 1144
Las Vegas, Nevada, 89106-4145
Withdrawn
Local Institution - 1117
Los Alamitos, California, 90720-6506
Active, not recruiting
Local Institution - 1039
Maitland, Florida, 32751-5669
Active, not recruiting
Local Institution - 1146
Maitland, Florida, 32751-6138
Active, not recruiting
Local Institution - 1149
Malvern, Pennsylvania, 19355-3267
Withdrawn
Local Institution - 1114
Marrero, Louisiana, 70072-3083
Active, not recruiting
Local Institution - 1159
Miami, Florida, 33032
Active, not recruiting
Local Institution - 1118
Miami, Florida, 33122-1721
Active, not recruiting
Local Institution - 1111
Miami, Florida, 33126-5683
Active, not recruiting
Local Institution - 1108
Miami, Florida, 33133-4231
Active, not recruiting
Local Institution - 1125
Miami, Florida, 33135-1601
Active, not recruiting
Local Institution - 1115
Miami, Florida, 33135
Active, not recruiting
Local Institution - 1143
Miami, Florida, 33145-2455
Active, not recruiting
Local Institution - 1113
Miami, Florida, 33155-6630
Active, not recruiting
Local Institution - 1009
Miami, Florida, 33155
Active, not recruiting
Local Institution - 1129
Miami, Florida, 33165-3947
Active, not recruiting
Local Institution - 1150
Miami, Florida, 33165
Active, not recruiting
Local Institution - 1109
Miami, Florida, 33174-2950
Active, not recruiting
Local Institution - 1158
Miami, Florida, 33175
Active, not recruiting
Local Institution - 1147
Miami, Florida, 33176-7947
Active, not recruiting
Local Institution - 1105
Miami, Florida, 33179-2537
Active, not recruiting
Local Institution - 1157
Miami, Florida, 33184-1412
Active, not recruiting
Local Institution - 1126
Miami Gardens, Florida, 33056-4000
Completed
Local Institution - 1102
Miami Lakes, Florida, 33014-6435
Completed
Local Institution - 1153
New Hyde Park, New York, 11042-2062
Withdrawn
Local Institution - 1136
Orlando, Florida, 32806-1041
Active, not recruiting
Local Institution - 1112
Orlando, Florida, 32807-3555
Active, not recruiting
Local Institution - 1044
Phoenix, Arizona, 85012-2836
Active, not recruiting
Local Institution - 1135
Port Jefferson Station, New York, 11776-3386
Withdrawn
Local Institution - 1137
Port Orange, Florida, 32127-2914
Active, not recruiting
Local Institution - 1121
Red Oak, Texas, 75154
Withdrawn
Local Institution - 1139
Rochester Hills, Michigan, 48307-2760
Active, not recruiting
Local Institution - 1103
Sherman Oaks, California, 91403-2131
Active, not recruiting
Local Institution - 1134
Stafford, Texas, 77477-3929
Active, not recruiting
Health Synergy Clinical Research,LLC - Stuart
Stuart, Florida, 34994
Mohammad Nisar, Site 1101, 786-831-7303
Recruiting
Local Institution - 1133
Sweetwater, Florida, 33182
Active, not recruiting
Local Institution - 1041
Tampa, Florida, 33607-4629
Active, not recruiting
Local Institution - 1124
Tampa, Florida, 33614-2700
Active, not recruiting
Local Institution - 1123
Tampa, Florida, 33614-2869
Completed
Local Institution - 1110
Tampa, Florida, 33629-5837
Active, not recruiting
Local Institution - 1040
The Villages, Florida, 32159-8986
Withdrawn
Local Institution - 1131
Viera, Florida, 32940
Site 1131
Recruiting
Local Institution - 1007
Walnut Creek, California, 94596
Active, not recruiting

Other trials in United States

China22 sites, 3 recruiting

Local Institution - 7004
Beijing, Beijing Municipality, 100025
Completed
Local Institution - 7045
Beijing, Beijing Municipality, 100070
Site 7045
Not yet recruiting
Local Institution - 7005
Beijing, Beijing Municipality, 100088
Active, not recruiting
Local Institution - 7002
Chengdu, Sichuan, 610000
Active, not recruiting
Local Institution - 7015
Chongqing, Chongqing Municipality, 400016
Active, not recruiting
Local Institution - 7008
Guangzhou, Guangdong, 0
Completed
Local Institution - 7016
Guangzhou, Guangdong, 510120
Active, not recruiting
Local Institution - 7009
Guangzhou, Guangdong, 510260
Active, not recruiting
Local Institution - 7017
Hangzhou, Zhejiang, 310003
Active, not recruiting
Local Institution - 7020
Hangzhou, Zhejiang, 310009
Completed
Local Institution - 7010
Hangzhou, Zhejiang, 310013
Active, not recruiting
Local Institution - 7006
Hangzhou, Zhejiang, 310014
Completed
Local Institution - 7007
Hefei, Anhui, 230022
Active, not recruiting
Local Institution - 7012
Nanchang, Jiangxi, 330008
Active, not recruiting
Local Institution - 7014
Nanjing, Jiangsu, 210009
Withdrawn
Local Institution - 7013
Nanjing, Jiangsu, 210011
Completed
Local Institution - 7001
Shanghai, Shanghai Municipality, 200030
Completed
Shanghai General Hospital - North Campus
Shanghai, Shanghai Municipality, 200080
Yuncheng Wu, Site 7011, +861360172334
Recruiting
Local Institution - 7003
Shenzhen, Guangdong, 518118
Active, not recruiting
Local Institution - 7019
Tianjin, Tianjin Municipality, 300222
Completed
Local Institution - 7018
Wenzhou, Zhejiang, 325000
Active, not recruiting
Local Institution - 7043
Zigong, Sichuan, 643000
Site 7043
Not yet recruiting

Other trials in China

United Kingdom10 sites

Local Institution - 2105
Aberdeen, AB25 2ZL
Withdrawn
Local Institution - 2109
Chertsey, KT16 9AU
Withdrawn
Local Institution - 2112
Edinburgh, EH4 2XU
Withdrawn
Local Institution - 2110
Ilford, Greater London, IG1 4HP
Withdrawn
Local Institution - 2106
Leeds, LS7 3JX
Withdrawn
Local Institution - 2101
London, Surrey, SE5 8AZ
Withdrawn
Local Institution - 2104
Motherwell, ML1 4UF
Withdrawn
Local Institution - 2111
Preston, PR2 9HT
Withdrawn
Local Institution - 2107
Sheffield, SouthYorkshire, s5 7JT
Withdrawn
Local Institution - 2108
Swinton, Greater Manchester, M27 8FF
Withdrawn

Other trials in United Kingdom

Poland9 sites

Local Institution - 4204
Bydgoszcz, 85-080
Active, not recruiting
Local Institution - 4208
Katowice, Silesian Voivodeship, 40-156
Completed
Local Institution - 4205
Katowice, 40-282
Active, not recruiting
Local Institution - 4207
Lodz, Lódzkie, 90-349
Active, not recruiting
Local Institution - 4202
Lodz, 90-227
Active, not recruiting
Local Institution - 4206
Lublin, Lublin Voivodeship, 20-064
Active, not recruiting
Local Institution - 4201
Ścinawa, 59-330
Active, not recruiting
Local Institution - 4209
Siemianowice Śląskie, 41-100
Withdrawn
Local Institution - 4203
Sopot, Pomeranian Voivodeship, 81-855
Withdrawn

Other trials in Poland

South Korea8 sites

Local Institution - 7208
Buk-gu, Daegu Gwang'yeogsi, 41404
Active, not recruiting
Local Institution - 7204
Busan, 49201
Withdrawn
Local Institution - 7205
Incheon, Incheon Gwang'yeogsi, 21565
Active, not recruiting
Local Institution - 7207
Seongnam-si, Gyeonggido, 13496
Active, not recruiting
Local Institution - 7202
Seongnam-si, 0
Active, not recruiting
Local Institution - 7206
Seoul, Seoul Teugbyeolsi, 03080
Completed
Local Institution - 7203
Seoul, 07071
Active, not recruiting
Local Institution - 7201
Seoul, 143-729
Active, not recruiting

Other trials in South Korea

Mexico7 sites

Local Institution - 1501
Culiacán, Sinaloa, 80020
Active, not recruiting
Local Institution - 1506
México, 03100
Active, not recruiting
Local Institution - 1503
Monterrey, Nuevo León, 64460
Active, not recruiting
Local Institution - 1505
Monterrey, Nuevo León, 64620
Active, not recruiting
Local Institution - 1502
Saltillo Centro, Coahuila, 25000
Active, not recruiting
Local Institution - 1507
Zapopan, Jalisco, 45170
Withdrawn
Local Institution - 1504
Zona Urbana Río Tijuana, Estado de Baja California, 22010
Withdrawn

Other trials in Mexico

Canada6 sites

Local Institution - 1605
Calgary, Alberta, T2N 1N4
Withdrawn
Local Institution - 1603
Hamilton, Ontario, ON L8M 1W9
Withdrawn
Local Institution - 1606
Montreal, Quebec, H4H 1R3
Withdrawn
Local Institution - 1602
Toronto, Ontario, M5B 1W8
Withdrawn
Local Institution - 1601
Verdun, Quebec, H4H 1R3
Withdrawn
Local Institution - 1604
Whitby, Ontario, L1N 5S9
Withdrawn

Other trials in Canada

Greece5 sites

Local Institution - 4805
Athens, Attica, 115 21
Active, not recruiting
Local Institution - 4803
Athens, Attica, 115 26
Active, not recruiting
Local Institution - 4802
Chaidari, Athens, Attica, 124 62
Active, not recruiting
Local Institution - 4801
Heraklion, 71110
Active, not recruiting
Local Institution - 4806
Marousi, Attica, 151 23
Active, not recruiting

Other trials in Greece

Turkey (Türkiye)5 sites

Local Institution - 4702
Atakum, Samsun, 55270
Active, not recruiting
Local Institution - 4701
Eskişehir, 26040
Active, not recruiting
Local Institution - 4704
Istanbul, 34093
Active, not recruiting
Local Institution - 4705
Izmir, 35210
Active, not recruiting
Local Institution - 4703
Izmir, 35575
Active, not recruiting

Other trials in Turkey (Türkiye)

Chile4 sites, 4 recruiting

Psicomed Estudios Medicos
Antofagasta, 1270244
Luis Barra, Site 6003, +56552240334
Recruiting
Local Institution - 6005
Las Condes, Santiago Metropolitan, 7550000
Site 6005
Not yet recruiting
Local Institution - 6001
Las Condes, 7550000
Site 6001
Recruiting
Biomedica Research Group
Providencia, Santiago Metropolitan, 7500000
Sergio Gloger Kojchen, Site 6002, +56226758700
Recruiting

Other trials in Chile

Belgium3 sites

Local Institution - 2801
Hasselt, Limburg, 3500
Active, not recruiting
Local Institution - 2802
Leuven, Vlaams Brabant, 3000
Active, not recruiting
Local Institution - 2803
Roeselare, West-Vlaanderen, 8800
Active, not recruiting

Other trials in Belgium

Hungary3 sites

Local Institution - 4602
Budapest, 1083
Active, not recruiting
Local Institution - 4603
Miskolc, 3526
Active, not recruiting
Local Institution - 4601
Pécs, Baranya, 7633
Active, not recruiting

Other trials in Hungary

Peru3 sites

Local Institution - 6101
Callao, Callao 2
Withdrawn
Local Institution - 6102
Miraflores, Lima region, 15046
Withdrawn
Local Institution - 6103
Pueblo Libre, Lima region, 15084
Active, not recruiting

Other trials in Peru

Switzerland2 sites

Local Institution - 2901
Geneva, Genève (fr), CH-1205
Withdrawn
Local Institution - 2902
Lausanne, Vaud (fr), 1011
Withdrawn

Other trials in Switzerland

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease

The primary objective of the study is to evaluate the efficacy of KarXT compared with placebo in the treatment of subjects with psychosis associated with AD as measured by the Neuropsychiatric Inventory-Clinician (NPI-C): Hallucinations and Delusions (H+D) score.

Conditions: Psychosis Associated With Alzheimer's Disease
Being tested: KarXT, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KarXTDrug
KarXT 20/2 mg (total daily dose [TDD] 60/6 mg) KarXT 30/3 mg (TDD 90/9 mg) KarXT 40/4 mg (TDD 120/12 mg) KarXT 50/5 mg (TDD 150/15 mg) KarXT 66.7/6.67 mg (TDD 200/20 mg)
PlaceboDrug
Placebo capsules

Study groups in NCT06126224
Study group	Role	What they receive
KarXT	Experimental	Xanomeline and Trospium Chloride Capsules Receives: Drug: KarXT
Placebo	Placebo comparator	Placebo capsules Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from Baseline to End of Treatment in the Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions (NPI-C: H+D) score
Neuropsychiatric Inventory-Clinician: Hallucinations and Delusions scale includes 2 domains from the NPI-C scale, namely, hallucinations and delusions. These 2 domains include the following number of items to be rated by the clinician: Hallucinations, 7 items (maximum score = 21) and Delusions, 8 items (maximum score = 24). The maximum score for the NPI-C: H+D scale is 45. Higher scores on this scale indicate worse outcomes.
Measured: Baseline and end of Treatment (up to 14 Weeks)

Secondary outcomes (5)

Change from Baseline to End of Treatment in the Clinical Global Impressions-Severity (CGI-S) scale
Clinical Global Impressions-Severity (CGI-S) requires the assessor to consider aspects of the psychosis (hallucinations and delusions) prior to providing a global assessment of severity. Higher scores on this scale indicate worse outcomes.
Measured: Baseline and end of Treatment (up to 14 Weeks)
Change From Baseline to end of Treatment in NPI-C Core score: Hallucinations, Delusions, Agitation, and Aggression Domains
Measured: Baseline and end of Treatment (up to 14 Weeks)
Change From Baseline to end of Treatment in NPI-C: Agitation score
Measured: Baseline and end of Treatment (up to 14 Weeks)
Change From Baseline to end of Treatment in NPI-C Core score: Caregiver Distress scale (Hallucinations, Delusions, Agitation, and Aggression domains)
Measured: Baseline and end of Treatment (up to 14 Weeks)
Responder Rate
Responder rate is defined as NPI-C: H+D score ≥ 40% improvement
Measured: Baseline and end of Treatment (up to 14 Weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Aug 20239 Dec 2026

First posted13 Nov 2023
Study start28 Aug 2023
Primary completion9 Dec 2026 (estimated)
Study completion9 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Psychosis Associated With Alzheimer's DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 500 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06126224
Sponsor's protocol ID: CN012-0027
Other IDs: KAR-032, CN012-0027, 2023-504416-16, 2023
Status last verified: Oct 2026
First submitted: 3 Nov 2023
Last updated: 16 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Interested in taking part?

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286

Clinical.Trials@bms.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 3
Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)
Psychosis Associated With Alzheimer's Disease
RecruitingPhase 2
A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Alzheimer's Disease Psychosis
Psychosis Associated With Alzheimer's Disease
RecruitingPhase 3
A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-1)
Psychosis Associated With Alzheimer's Disease
Enrolling by invitationPhase 2
An Open-Label Study of ML-007C-MA in Adults With Alzheimer's Disease Psychosis
Psychosis Associated With Alzheimer's Disease
Not yet recruitingPhase 1
A Phase 1, MAD Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LY03017
Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis, Hallucinations and Delusions Associated With Parkinson Disease Psychosis

All Psychosis Associated With Alzheimer's Disease trials