Evaluating NMRA-323511 for Agitation in Alzheimer's Patients and Healthy Elderly

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

This study is testing a new medication called NMRA-323511 to see if it can help reduce agitation in people with Alzheimer's and to check its safety in healthy older adults.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 55 Years to 90 Years
• Sex: All
• Sponsor: Neumora Therapeutics, Inc. (Industry-sponsored)
• Locations: 25 sites (Chandler, Arizona and 24 other locations)
• Trial ID: NCT06546995 on ClinicalTrials.gov

What this trial studies

This clinical trial consists of two parts: Part A focuses on healthy elderly individuals aged 65 to 80 to assess the safety, tolerability, and pharmacokinetics of NMRA-323511 in a randomized, double-blind, placebo-controlled setting. Part B targets adults aged 55 to 90 with agitation associated with Alzheimer's Disease, evaluating the safety, tolerability, and efficacy of the same treatment. Both parts include a screening period, a treatment period, and a follow-up visit to monitor participants' health and response to the medication.

Who should consider this trial

Good fit: Ideal candidates include healthy elderly individuals aged 65 to 80 for Part A and adults aged 55 to 90 with a diagnosis of Alzheimer's Disease and associated agitation for Part B.

Not a fit: Patients with dementia or memory impairment due to causes other than Alzheimer's Disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for managing agitation in patients with Alzheimer's Disease.

How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promise in addressing agitation in dementia patients, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

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 this trial is running

Chandler, Arizona and 24 other locations

• Neumora Investigator Site — Chandler, Arizona, United States (Recruiting)
• Neumora Investigator Site — Tempe, Arizona, United States (Active_not_recruiting)
• Neumora Investigator Site — Costa Mesa, California, United States (Recruiting)
• Neumora Investigator Site — Lomita, California, United States (Recruiting)
• Neumora Investigator Site — Walnut Creek, California, United States (Active_not_recruiting)
• Neumora Investigator Site — Bradenton, Florida, United States (Recruiting)
• Neumora Investigator Site — Greenacres City, Florida, United States (Recruiting)
• Neumora Investigator Site — Hallandale Beach, Florida, United States (Recruiting)
• Neumora Investigator Site — Hialeah, Florida, United States (Recruiting)
• Neumora Investigator Site — Miami Springs, Florida, United States (Recruiting)
• Neumora Investigator Site — Miami, Florida, United States (Recruiting)
• Neumora Investigator Site — Miami, Florida, United States (Recruiting)
• Neumora Investigator Site — Miami, Florida, United States (Recruiting)
• Neumora Investigator Site — Orlando, Florida, United States (Recruiting)
• Neumora Investigator Site — Pembroke Pines, Florida, United States (Recruiting)
• Neumora Investigator Site — Atlanta, Georgia, United States (Recruiting)
• Neumora Investigator Site — Honolulu, Hawaii, United States (Recruiting)
• Neumora Investigator Site — Boise, Idaho, United States (Recruiting)
• Neumora Investigator Site — Belmont, Massachusetts, United States (Recruiting)
• Neumora Investigator Site — Troy, Michigan, United States (Recruiting)
• Neumora Investigator Site — Toms River, New Jersey, United States (Recruiting)
• Neumora Investigator Site — Brooklyn, New York, United States (Recruiting)
• Neumora Investigator Site — East Syracuse, New York, United States (Recruiting)
• Neumora Investigator Site — Charlotte, North Carolina, United States (Recruiting)
• Neumora Investigator Site — Mesquite, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Study Contact

Conditions Alzheimer's Disease; Healthy Elderly; Agitation Associated Dementia; NMRA-323511