NCT06546995

Study to Evaluate the Effects of NMRA-323511 Among Healthy Elderly and Adults With Agitation Associated With Dementia Due to Alzheimer's Disease

A Phase 1b, Randomized, Double-blind, Placebo-controlled Pilot Study to Evaluate the Effects of NMRA-323511 Among Healthy Elderly and Adults With Agitation Associated With Dementia Due to Alzheimer's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Neumora Therapeutics, Inc. · Industry
• Sex: All
• Age: 55 Years – 90 Years
• Healthy volunteers: Accepted

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.

Conditions

• Alzheimer's Disease
• Healthy Elderly

Interventions

Type	Name	Description
DRUG	NMRA-323511	Participants will receive NMRA-323511 orally.
DRUG	Placebo	Participants will receive matching placebo tablets orally.

Timeline

• Start date: 2024-07-09
• Primary completion: 2025-11-19
• Completion: 2025-11-19
• First posted: 2024-08-09
• Last updated: 2025-11-21

Locations

26 sites across 1 country: United States

Regulatory

• FDA-regulated drug study