Lewy body dementia drug pipeline

Upcoming readouts & recent results

• 2025-07-29ReportedZervimesineFull resultsmetNCT05225415

  Full SHIMMER results presented in an AAIC 2025 podium presentation (with additional analyses spanning DLB and AD) and published in Alzheimer's & Dementia (Galvin et al. 2025): consistent benefit of zervimesine over placebo across neuropsychiatric, cognitive, motor and functional domains in mild-to-moderate DLB. ↗

• 2024-12-18ReportedZervimesineTopline datametNCT05225415

  Phase 2 SHIMMER topline (130 mild-to-moderate DLB patients, zervimesine 100/300 mg vs placebo, 6 months): primary safety/tolerability endpoint met, with exploratory efficacy signals across behavioral (NPI-12 -82% vs placebo decline), cognitive-fluctuation (CAF -91%), motor (UPDRS-III -62%) and functional (ADCS-ADL -52%) measures. ↗

See the full catalyst calendar →

Compounds in development (1)

Also in development for subtypes of Lewy body dementia

• RemlifanserinPhase 2ACADIA Pharmaceuticals Inc.for Lewy body dementia psychosis

Trials recruiting now (12)

12 drug-interventional lewy body dementia trials recruiting now, of 65 registered interventional trials. Browse all on ClinicalTrials.gov →

• Phase 4Elucidating the Role of Cholinergic Degeneration in Cognitive Fluctuations in Lewy Body Dementia

  Galantamine HBr extended-release 8mg capsules (8mg ER).

  Virginia Commonwealth Universityn=120United States · 1 siteStarted Dec 2025NCT07284290
• Phase 4Comparing Antipsychotic Medications in LBD Over Time

  Pimavanserin, Quetiapine

  The University of Texas Health Science Center at San Antonion=94United States · 2 sitesStarted Apr 2022NCT05590637
• Phase 352-Week, Phase 3, Open-Label Extension Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)

  ACP-204

  ACADIA Pharmaceuticals Inc.n=126Bulgaria, Czechia +1 · 15 sitesStarted Nov 2025Tracked: RemlifanserinNCT07095465
• Phase 318F-DOPA II - PET Imaging Optimization

  Furosemide Injection

  University of Albertan=800Canada · 1 siteStarted Jan 2021NCT04706910
• Phase 2A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)

  Donanemab, Placebo

  Eli Lilly and Companyn=350Japan, South Korea +2 · 72 sitesStarted May 2026NCT07589595
• Phase 2A Double-Blind, Placebo-Controlled, Phase 2, Efficacy and Safety Study of ACP-204 in Adults With Lewy Body Dementia Psychosis (LBDP)

  ACP-204, Placebo

  ACADIA Pharmaceuticals Inc.n=180Bulgaria, Czechia +4 · 56 sitesStarted Aug 2025Tracked: RemlifanserinNCT07029581
• Phase 2Safety and Efficacy of AR1005 in Patients with Lewy Body Disease

  AR1005, Placebo, Rivastigmine 3 mg

  Yonsei Universityn=60South Korea · 1 siteStarted Jan 2024NCT06537076
• Phase 2Ambroxol in New and Early DLB, A Phase IIa Multicentre Randomized Controlled Double Blind Clinical Trial

  Ambroxol, Placebo

  Helse Fonnan=180Norway · 8 sitesStarted May 2021NCT04588285
• Phase 1/2Terazosin for Dementia With Lewy Bodies

  Terazosin Hydrochloride

  Qiang Zhangn=40United States · 1 siteStarted Oct 2027NCT04760860
• Phase 1/2Ambroxol as a Novel Disease Modifying Treatment for Lewy Body Dementia

  Ambroxol Hydrochloride

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sn=15Canada · 1 siteStarted Jan 2025NCT04405596
• Phase 1hUC-MSC-sEV-001 Nasal Drops for Neurodegenerative Diseases

  hUC-MSC-sEV-001 nasal drops

  Xuanwu Hospital, Beijingn=120China · 1 siteStarted Jul 2025NCT06607900
• Phase 1[18F]F-DOPA Imaging in Patients With Autonomic Failure

  Carbidopa 200mg oral dose, Entacapone 400mg oral dose

  Daniel Claassenn=40United States · 1 siteStarted Feb 2020NCT04246437