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

Completed · Phase 1 · Has a placebo group

Conditions studied: Alzheimer's Disease, Healthy Elderly

In brief

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.

Key facts

Study ID

NCT06546995

Run by

Neumora Therapeutics, Inc.

People needed

87

Starts

2024-07-09

Expected to finish

2025-11-19

Last updated by the study team

2026-05-22

Who can join

Age: 55 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Part A
• Healthy participants
• Age 65 to 80 years
• Body mass index (BMI) ≥18.0 and ≤32.0 kg/m\^2 at the screening and check-in visit
• Part B
• Participants aged 55 to 90 years
• Diagnosis of probable AD or Alzheimer's clinical syndrome according to the National Institute of Aging-Alzheimer's Association criteria at least 12 months prior to screening
• Agitation meets the International Psychogeriatric Association (IPA) consensus definition
• Mini-Mental State Examination (MMSE) score = 5 - 24 (mild to severe dementia) at screening

You may not qualify if…

• Part A
• Participant is actively suicidal
• Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit
• Diagnosis of epilepsy taking anticonvulsants for seizure control, history of seizures
• Part B
• Dementia or memory impairment due to a reason other than AD
• Clinically significant neurologic disorder other than AD
• Have any clinically significant and uncontrolled medical condition
• Note: Other protocol defined inclusion/exclusion criteria may apply

Where it is running

• 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

Full record on ClinicalTrials.gov

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