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

Last updated: October 9, 2025
Sponsor: Neumora Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Dementia

Manic Disorders

Williams Syndrome

Treatment

Placebo

NMRA-323511

Clinical Study ID

NCT06546995
NMRA-323511-104
  • Ages 55-90
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 NationalInstitute of Aging-Alzheimer's Association criteria at least 12 months prior toscreening

  • Agitation meets the International Psychogeriatric Association (IPA) consensusdefinition

  • Mini-Mental State Examination (MMSE) score = 5 - 24 (mild to severe dementia) atscreening

Exclusion

Exclusion Criteria:

Part A

  • Participant is actively suicidal

  • Is mentally or legally incapacitated or has significant emotional problems at thetime of the screening visit

  • Diagnosis of epilepsy taking anticonvulsants for seizure control, history ofseizures

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

Study Design

Total Participants: 96
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
July 09, 2024
Estimated Completion Date:
November 30, 2025

Connect with a study center

  • Neumora Investigator Site

    Chandler, Arizona 85286
    United States

    Site Not Available

  • Neumora Investigator Site

    Tempe, Arizona 85283
    United States

    Site Not Available

  • Neumora Investigator Site

    Chandler 5289282, Arizona 5551752 85286
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Tempe 5317058, Arizona 5551752 85283
    United States

    Site Not Available

  • Neumora Investigator Site

    Costa Mesa, California 92626
    United States

    Site Not Available

  • Neumora Investigator Site

    Lomita, California 90717
    United States

    Site Not Available

  • Neumora Investigator Site

    Walnut Creek, California 94596
    United States

    Site Not Available

  • Neumora Investigator Site

    Costa Mesa 5339840, California 5332921 92626
    United States

    Completed

  • Neumora Investigator Site

    Lomita 5367767, California 5332921 90717
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Walnut Creek 5406990, California 5332921 94596
    United States

    Completed

  • Neumora Investigator Site

    Bradenton, Florida 34205
    United States

    Site Not Available

  • Neumora Investigator Site

    Greenacres City, Florida 33467
    United States

    Site Not Available

  • Neumora Investigator Site

    Hallandale Beach, Florida 33009
    United States

    Site Not Available

  • Neumora Investigator Site

    Hialeah, Florida 33016
    United States

    Site Not Available

  • Neumora Investigator Site

    Miami, Florida 33155
    United States

    Site Not Available

  • Neumora Investigator Site

    Miami Springs, Florida 33166
    United States

    Site Not Available

  • Neumora Investigator Site

    Orlando, Florida 32807
    United States

    Site Not Available

  • Neumora Investigator Site

    Pembroke Pines, Florida 33024
    United States

    Site Not Available

  • Neumora Investigator Site

    Bradenton 4148708, Florida 4155751 34205
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Greenacres City 4157467, Florida 4155751 33467
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Hallandale 4157898, Florida 4155751 33009
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Hialeah 4158476, Florida 4155751 33016
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Miami 4164138, Florida 4155751 33126
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Miami Springs 4164223, Florida 4155751 33166
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Orlando 4167147, Florida 4155751 32807
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Pembroke Pines 4168139, Florida 4155751 33024
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Port Orange 4169156, Florida 4155751 32127
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Atlanta, Georgia 30318
    United States

    Site Not Available

  • Neumora Investigator Site

    Atlanta 4180439, Georgia 4197000 30318
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Honolulu, Hawaii 96817
    United States

    Site Not Available

  • Neumora Investigator Site

    Honolulu 5856195, Hawaii 5855797 96817
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Boise, Idaho 83704
    United States

    Site Not Available

  • Neumora Investigator Site

    Boise 5586437, Idaho 5596512 83704
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Belmont, Massachusetts 02478
    United States

    Site Not Available

  • Neumora Investigator Site

    Belmont 4930282, Massachusetts 6254926 02478
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Troy, Michigan 48085
    United States

    Site Not Available

  • Neumora Investigator Site

    Troy 5012639, Michigan 5001836 48085
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Toms River, New Jersey 08755
    United States

    Site Not Available

  • Neumora Investigator Site

    Toms River 4504476, New Jersey 5101760 08755
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Brooklyn, New York 11229
    United States

    Site Not Available

  • Neumora Investigator Site

    East Syracuse, New York 13057
    United States

    Site Not Available

  • Neumora Investigator Site

    Brooklyn 5110302, New York 5128638 11229
    United States

    Active - Recruiting

  • Neumora Investigator Site

    East Syracuse 5116079, New York 5128638 13057
    United States

    Completed

  • Neumora Investigator Site

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Neumora Investigator Site

    Charlotte 4460243, North Carolina 4482348 28204
    United States

    Active - Recruiting

  • Neumora Investigator Site

    Mesquite, Texas 75149
    United States

    Site Not Available

  • Neumora Investigator Site

    Mesquite 4710826, Texas 4736286 75149
    United States

    Active - Recruiting

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