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Study to Evaluate the Effects of NMRA-323511 Among Healthy Elderly and Adults With Agitation Associated With Dementia Due to Alzheimer's Disease
Sponsor: Neumora Therapeutics, Inc.
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.
Official title: 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
Key Details
Gender
All
Age Range
55 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
87
Start Date
2024-07-09
Completion Date
2025-11-19
Last Updated
2026-05-22
Healthy Volunteers
Yes
Conditions
Interventions
NMRA-323511
Participants will receive NMRA-323511 orally.
Placebo
Participants will receive matching placebo tablets orally.
Locations (26)
Neumora Investigator Site
Chandler, Arizona, United States
Neumora Investigator Site
Tempe, Arizona, United States
Neumora Investigator Site
Costa Mesa, California, United States
Neumora Investigator Site
Lomita, California, United States
Neumora Investigator Site
Walnut Creek, California, United States
Neumora Investigator Site
Bradenton, Florida, United States
Neumora Investigator Site
Greenacres City, Florida, United States
Neumora Investigator Site
Hallandale, Florida, United States
Neumora Investigator Site
Hialeah, Florida, United States
Neumora Investigator Site
Miami, Florida, United States
Neumora Investigator Site
Miami, Florida, United States
Neumora Investigator Site
Miami, Florida, United States
Neumora Investigator Site
Miami Springs, Florida, United States
Neumora Investigator Site
Orlando, Florida, United States
Neumora Investigator Site
Pembroke Pines, Florida, United States
Neumora Investigator Site
Port Orange, Florida, United States
Neumora Investigator Site
Atlanta, Georgia, United States
Neumora Investigator Site
Honolulu, Hawaii, United States
Neumora Investigator Site
Boise, Idaho, United States
Neumora Investigator Site
Belmont, Massachusetts, United States
Neumora Investigator Site
Troy, Michigan, United States
Neumora Investigator Site
Toms River, New Jersey, United States
Neumora Investigator Site
Brooklyn, New York, United States
Neumora Investigator Site
East Syracuse, New York, United States
Neumora Investigator Site
Charlotte, North Carolina, United States
Neumora Investigator Site
Mesquite, Texas, United States