Alzheimer's disease psychosis drug pipeline

Upcoming readouts & recent results

• September to October 2026AnticipatedRemlifanserinTopline dataNCT06159673

  Topline results from the Phase 2 RADIANT substudy of remlifanserin (ACP-204) 30 mg and 60 mg vs placebo in Alzheimer's disease psychosis (primary endpoint: change from baseline in SAPS-H+D at Week 6), expected September–October 2026. ↗

• early 2027DelayedXanomeline/trospium chloride (Cobenfy)Topline dataNCT06126224

  Topline results from ADEPT-2, the first acute-efficacy Phase 3 of Cobenfy in Alzheimer's disease psychosis (primary endpoint: change in NPI-C Hallucinations and Delusions score), now expected among readouts beginning early 2027. ↗

• 2027 (potential interim analysis late 2026)DelayedXanomeline/trospium chloride (Cobenfy)Topline dataNCT05511363

  Topline from ADEPT-1, the Phase 3 relapse-prevention (randomized-withdrawal) study of Cobenfy in Alzheimer's disease psychosis: among readouts beginning early 2027 and spread across the year, with a potential interim analysis later in 2026. ↗

• 2027DelayedXanomeline/trospium chloride (Cobenfy)Topline dataNCT06585787

  Topline from ADEPT-4, the second acute-efficacy Phase 3 of Cobenfy in Alzheimer's disease psychosis (NPI-C H+D primary endpoint): among readouts beginning early 2027 and spread across the year. ↗

• 2H 2027AnticipatedML-007C-MATopline dataNCT06887192

  Topline results from the Phase 2 VISTA trial of ML-007C-MA 210/3 mg BID versus placebo in hallucinations and delusions associated with Alzheimer's disease psychosis — primary endpoint change from baseline in NPI-C H+D score at Week 7 — expected in the second half of 2027. ↗

• January 2028AnticipatedRemlifanserinRegistry resultsNCT06159673

  ClinicalTrials.gov estimated primary completion of the full RADIANT master protocol (NCT06159673), which covers both Phase 3 confirmatory substudies: January 2028 (estimated study completion February 2028). ↗

See the full catalyst calendar →

Compounds in development (3)

Trials recruiting now (9)

9 drug-interventional alzheimer's disease psychosis trials recruiting now, of 9 registered interventional trials. Browse all on ClinicalTrials.gov →

• Phase 3ADEPT-5: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of KarXT + KarX-EC for Psychosis Associated With Alzheimer's Disease

  KarXT, KarX-EC, KarXT + KarX-EC Arm Matching Placebo

  Bristol-Myers Squibb Companyn=325Australia, Canada +3 · 22 sitesStarted Mar 2026Tracked: Xanomeline/trospium chloride (Cobenfy)NCT06947941
• Phase 3ADEPT-4: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety and Efficacy of KarXT for Psychosis Associated With Alzheimer's Disease

  KarXT, Placebo

  Bristol-Myers Squibb Companyn=406Argentina, Belgium +23 · 289 sitesStarted Sep 2024Tracked: Xanomeline/trospium chloride (Cobenfy)NCT06585787
• Phase 3A 52-Week, Open-Label Extension Study of ACP-204 in Adults With Alzheimer's Disease Psychosis

  ACP-204

  ACADIA Pharmaceuticals Inc.n=752Brazil, Bulgaria +10 · 71 sitesStarted Apr 2024Tracked: RemlifanserinNCT06194799
• Phase 3ADEPT-2: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Safety and Efficacy of KarXT for Psychosis Associated With Alzheimer's Disease

  KarXT, Placebo

  Bristol-Myers Squibb Companyn=500Belgium, Canada +12 · 154 sitesStarted Aug 2023Tracked: Xanomeline/trospium chloride (Cobenfy)NCT06126224
• Phase 3ADEPT-3: Open-Label Extension Study of the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease

  KarXT

  Bristol-Myers Squibb Companyn=1,000Argentina, Belgium +29 · 428 sitesStarted Jul 2023Tracked: Xanomeline/trospium chloride (Cobenfy)NCT05980949
• Phase 3ADEPT-1: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Relapse Prevention Study of KarXT for Psychosis Associated With Alzheimer's Disease

  KarXT, Placebo

  Bristol-Myers Squibb Companyn=410Bulgaria, Croatia +9 · 116 sitesStarted Aug 2022Tracked: Xanomeline/trospium chloride (Cobenfy)NCT05511363
• Phase 2/3A Master Protocol for Three Independent, Seamlessly Enrolling, Double-blind, Placebo-controlled Efficacy and Safety Studies of ACP-204 in Adults With Alzheimer's Disease Psychosis

  ACP-204, Placebo

  ACADIA Pharmaceuticals Inc.n=1,074Brazil, Bulgaria +10 · 145 sitesStarted Nov 2023Tracked: RemlifanserinNCT06159673
• Phase 2An Open-Label Study to Assess the Long-Term Safety and Tolerability of ML-007C-MA in Adult Participants With Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis

  ML-007C-MA

  MapLight Therapeutics, Inc.n=210United States · 3 sitesStarted Mar 2026Tracked: ML-007C-MANCT07459660
• Phase 2A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of ML-007C-MA for the Treatment of Hallucinations and Delusions Associated With Alzheimer's Disease Psychosis (VISTA)

  ML-007C-MA, Placebo

  MapLight Therapeutics, Inc.n=300Argentina, Bulgaria +6 · 40 sitesStarted Aug 2025Tracked: ML-007C-MANCT06887192