Psychosis Associated With Alzheimer's Disease

Neurology
2
Pipeline Programs
2
Companies
19
Clinical Trials
16 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
1
0
1
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

2 companies ranked by most advanced pipeline stage

Bristol Myers Squibb
1 program
1
KarXTPhase 35 trials
Active Trials
NCT07284745Not Yet Recruiting176Est. Jul 2029
NCT07285798Not Yet Recruiting176Est. Aug 2029
NCT07379827Recruiting1,500Est. Jun 2028
+2 more trials
MapLight Therapeutics
MapLight TherapeuticsMA - Burlington
1 program
1
ML-007C-MAPhase 21 trial
Active Trials
NCT06887192Recruiting300Est. Dec 2027

Trial Timeline

Clinical trial activity over time

2023
2024
2025
2026
2027
2028
2029
Bristol Myers SquibbKarXT
Bristol Myers SquibbKarXT
Bristol Myers SquibbKarXT
Bristol Myers SquibbKarXT
Bristol Myers SquibbKarXT
Bristol Myers SquibbKarXT
Bristol Myers SquibbKarXT
Bristol Myers SquibbKarXT
Bristol Myers SquibbKarXT
Bristol Myers SquibbKarXT
Bristol Myers SquibbKarXT
Bristol Myers SquibbKarXT
Bristol Myers SquibbKarXT
Bristol Myers SquibbKarXT
Bristol Myers SquibbKarXT

Showing 15 of 19 trials with date data

Clinical Trials (19)

Total enrollment: 7,358 patients across 19 trials

A Study to Evaluate the Effect of KarXT on Urological Safety

Start: Jan 2026Est. completion: Dec 202760 patients
Phase 4Recruiting

A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder

Start: Feb 2026Est. completion: Aug 2029176 patients
Phase 3Not Yet Recruiting

A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism

Start: Feb 2026Est. completion: Jul 2029176 patients
Phase 3Not Yet Recruiting

A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Schizophrenia in Adolescents (EMERGENT TEEN)

Start: Jan 2026Est. completion: Dec 2029166 patients
Phase 3Recruiting

A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3)

Start: Dec 2025Est. completion: Jul 2029600 patients
Phase 3Recruiting

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

Start: Oct 2025Est. completion: Jun 2027424 patients
Phase 3Recruiting

A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)

Start: Jul 2025Est. completion: Oct 20271,046 patients
Phase 3Not Yet Recruiting

A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)

Start: Jul 2025Est. completion: Jun 2028450 patients
Phase 3Recruiting

A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-2)

Start: Jul 2025Est. completion: Nov 2028352 patients
Phase 3Recruiting

A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease

Start: Jul 2025Est. completion: Feb 2029586 patients
Phase 3Recruiting

A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)

Start: Jul 2025Est. completion: Dec 2028352 patients
Phase 3Recruiting

A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)

Start: Jun 2025Est. completion: Nov 2026274 patients
Phase 3Recruiting

A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder

Start: Jun 2025Est. completion: Nov 2026274 patients
Phase 3Recruiting

A Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Participants With Schizophrenia

Start: Jun 2025Est. completion: Aug 2029250 patients
Phase 3Recruiting

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)

Start: Jul 2023Est. completion: Sep 2027
Phase 3Recruiting

A Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Alzheimer's Disease Psychosis

Start: Aug 2025Est. completion: Dec 2027300 patients
Phase 2Recruiting

A Study to Evaluate Novel KarX and KarT Prototypes Versus the KarXT and KarX-EC Reference Following Single Doses, and to Explore the Effect of Food After Multiple Doses of Selected Prototypes in Healthy Adult Participants

Start: Jun 2025Est. completion: Aug 202672 patients
Phase 1Recruiting

Effectiveness and Adverse-effect Switch Evaluation of Xanomeline and Trospium Chloride (KarXT)

Start: Feb 2026Est. completion: Jun 20281,500 patients
N/ARecruiting

Evaluation of Treatment Satisfaction and KarXT Utilization Registry (RESKU)

Start: Sep 2025Est. completion: May 2029300 patients
N/ARecruiting

Related Jobs in Neurology

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

1 late-stage (Phase 3) programs — potential near-term approvals
16 actively recruiting trials targeting 7,358 patients
2 companies competing in this space