CompletedPhase 1

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

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

Lead sponsor

Neumora Therapeutics, Inc.

Asset

NMRA-323511

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 5-24•Healthy volunteers

Primary endpoints

•Part•Part B

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06546995

Org study IDNMRA-323511-104

Timeline

Milestones

Study start2024-07-09actual

Study first posted2024-08-09actual

Primary completion2025-11-19actual

Study completion2025-11-19actual

Last update posted2026-05-22actual

Assets

Drug assets

NMRA-323511

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age90 Years

SexAll

Healthy volunteersAccepted

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

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Behavior / neuropsychiatric

1 endpoint

Primary/protocol endpoint

Part B: Change from Baseline to Week 8 on the Cohen-Mansfield Agitation Inventory (CMAI) Total Score

Time frame:Baseline to Week 8

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Part A: Safety and Tolerability Assessments Based on Treatment Emergent Adverse Events (TEAEs) and Validated Clinical Scales

Time frame:Up to 53 days

event count, event

Primary/protocol endpoint

Part B: Safety and Tolerability Assessments Based on Treatment Emergent Adverse Events and Validated Clinical Scales

Time frame:Up to Week 10

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.