Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 1

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

NCT06546995 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG Placebo
  • DRUG NMRA-323511

Study Locations (20)

Florida

  • Neumora Investigator Site — Bradenton
  • Neumora Investigator Site — Greenacres City
  • Neumora Investigator Site — Hallandale
  • Neumora Investigator Site — Hialeah
  • Neumora Investigator Site — Miami
  • Neumora Investigator Site — Miami
  • Neumora Investigator Site — Miami
  • Neumora Investigator Site — Miami Springs
  • Neumora Investigator Site — Orlando
  • Neumora Investigator Site — Pembroke Pines
  • Neumora Investigator Site — Port Orange

California

  • Neumora Investigator Site — Costa Mesa
  • Neumora Investigator Site — Lomita
  • Neumora Investigator Site — Walnut Creek

Arizona

  • Neumora Investigator Site — Chandler
  • Neumora Investigator Site — Tempe

Georgia

  • Neumora Investigator Site — Atlanta

Hawaii

  • Neumora Investigator Site — Honolulu

Idaho

  • Neumora Investigator Site — Boise

Massachusetts

  • Neumora Investigator Site — Belmont

Trial Details

FieldValue
Enrollment Target 96 participants
Start Date 2024-07-09
Est. Completion 2025-11-19
Phase Phase 1

Sponsor

Neumora Therapeutics

5 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06546995

The ClinicalTrials.gov registry entry for NCT06546995 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Neumora Therapeutics, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Alzheimer's Disease appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06546995 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Florida, California, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06546995 about?

NCT06546995 is a clinical study titled "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 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, place...

What is the current status of trial NCT06546995?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 96 participants. The study started on 2024-07-09. Estimated completion is 2025-11-19.

What conditions does trial NCT06546995 study?

This clinical trial studies the following conditions: Alzheimer's Disease, Healthy Elderly. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06546995?

The interventions under investigation include: Placebo (DRUG), NMRA-323511 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06546995?

This trial is sponsored by Neumora Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06546995 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial