Life sciences · Phase 1 Trial
ClinicalTrials.gov · November 6, 2026
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Phase 1 Trial.
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Registry record from ClinicalTrials.gov (NCT06546995). This is a study registration, not published results. Lead sponsor: Neumora Therapeutics, Inc.. Recruitment status: COMPLETED. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 87 participants (ACTUAL). Conditions: Alzheimer's Disease, Healthy Elderly. Interventions: DRUG: NMRA-323511; DRUG: Placebo. Primary outcome measures: Part A: Safety and Tolerability Assessments Based on Treatment Emergent Adverse Events (TEAEs) and Validated Clinical Scales , Up to 53 days; Part B: Safety and Tolerability Assessments Based on Treatment Emergent Adverse Events and Validated Clinical Scales , Up to Week 10; Part B: Change from Baseline to Week 8 on the Cohen-Mansfield Agitation Inventory (CMAI) Total Score , Baseline to Week 8. Brief summary: This study consists of 2 parts, Part A and Part B. Part A is a single center, randomized, double-blind, placebo-controlled cohort designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of NMRA-323511 among healthy elderly. Part B is a multicenter, randomized, double-blinded, placebo-controlled, parallel-group cohort to evaluate the safety, tolerability, and efficacy of NMRA-323511 among adults with Agitation Associated with Dementia due to Alzheimer's Disease. Part A consists of a Screening Period (up to 28 days), a 10-day Treatment Period, and a 10- day Follow-up clinic visit after last dose of study treatment. Part B consists of a Screening Period (up to 28 days), an 8-week Treatment Period, and a 10-day Follow-up clinic visit after last dose of study treatment.