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New drug aims to calm agitation in Alzheimer's patients

NCT ID NCT06546995

Symptom relief Sponsor: Neumora Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested an experimental drug, NMRA-323511, in healthy older adults and people with Alzheimer's disease who experience agitation. The goal was to see if the drug is safe and can reduce agitated behaviors like pacing or yelling. The study involved 87 participants and lasted up to 8 weeks of treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

87 people

The number who actually took part.

Started

Jul 2024

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

55 to 90 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Alzheimer disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer's disease Healthy elderly

Contacts and locations

Locations

  • Neumora Investigator Site

    Chandler, Arizona, 85286, United States

  • Neumora Investigator Site

    Tempe, Arizona, 85283, United States

  • Neumora Investigator Site

    Costa Mesa, California, 92626, United States

  • Neumora Investigator Site

    Lomita, California, 90717, United States

  • Neumora Investigator Site

    Walnut Creek, California, 94596, United States

  • Neumora Investigator Site

    Bradenton, Florida, 34205, United States

  • Neumora Investigator Site

    Greenacres City, Florida, 33467, United States

  • Neumora Investigator Site

    Hallandale, Florida, 33009, United States

  • Neumora Investigator Site

    Hialeah, Florida, 33016, United States

  • Neumora Investigator Site

    Miami, Florida, 33126, United States

  • Neumora Investigator Site

    Miami, Florida, 33137, United States

  • Neumora Investigator Site

    Miami, Florida, 33155, United States

  • Neumora Investigator Site

    Miami Springs, Florida, 33166, United States

  • Neumora Investigator Site

    Orlando, Florida, 32807, United States

  • Neumora Investigator Site

    Pembroke Pines, Florida, 33024, United States

  • Neumora Investigator Site

    Port Orange, Florida, 32127, United States

  • Neumora Investigator Site

    Atlanta, Georgia, 30318, United States

  • Neumora Investigator Site

    Honolulu, Hawaii, 96817, United States

  • Neumora Investigator Site

    Boise, Idaho, 83704, United States

  • Neumora Investigator Site

    Belmont, Massachusetts, 02478, United States

  • Neumora Investigator Site

    Troy, Michigan, 48085, United States

  • Neumora Investigator Site

    Toms River, New Jersey, 08755, United States

  • Neumora Investigator Site

    Brooklyn, New York, 11229, United States

  • Neumora Investigator Site

    East Syracuse, New York, 13057, United States

  • Neumora Investigator Site

    Charlotte, North Carolina, 28204, United States

  • Neumora Investigator Site

    Mesquite, Texas, 75149, United States

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