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NMRA-323511 for Agitation in Alzheimer's Disease

Verified Trial
Phase 1
Recruiting
Research Sponsored by Neumora Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Do you experience agitation or irritation related to not being able to remember things?
Be older than 18 years old
Must not have
Have you been diagnosed with a serious health condition outside of Alzheimer's?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 53 days

Summary

This trial has two parts, Part A and Part B. Part A is focused on testing the safety, tolerability, and how the body processes a drug called NMRA-323511 in healthy

Who is the study for?
This trial is for healthy elderly individuals and adults with agitation due to Alzheimer's dementia. Participants must pass a screening and be eligible based on specific criteria not detailed here.
What is being tested?
The study tests NMRA-323511 against a placebo in two parts: Part A focuses on safety in healthy elderly, while Part B assesses safety and effectiveness in those with Alzheimer's-related agitation.
What are the potential side effects?
Potential side effects of NMRA-323511 are not specified but typically include reactions at the drug administration site, gastrointestinal issues, fatigue, or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 53 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 53 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part A: Safety and Tolerability Assessments Based on Treatment Emergent Adverse Events (TEAEs) and Validated Clinical Scales
Part B: Change from Baseline to Week 8 on the Cohen-Mansfield Agitation Inventory (CMAI) Total Score
Part B: Safety and Tolerability Assessments Based on Treatment Emergent Adverse Events and Validated Clinical Scales

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B: NMRA-323511Experimental Treatment1 Intervention
Group II: Part A: NMRA-323511Experimental Treatment1 Intervention
Group III: Part A: PlaceboPlacebo Group1 Intervention
Group IV: Part B: PlaceboPlacebo Group1 Intervention

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Neumora Therapeutics, Inc.Lead Sponsor
6 Previous Clinical Trials
1,910 Total Patients Enrolled
~64 spots leftby Nov 2025
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