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NCT06546995 · ClinicalTrials.gov registry record · 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

A Phase 1 study of Alzheimers Disease and Healthy Elderly, sponsored by Neumora Therapeutics.

Completed
Registry status
Phase 1
Development phase
96
Enrollment target
20
Study locations

NCT06546995: Completed Phase 1 study of Alzheimers Disease and Healthy Elderly, sponsored by Neumora Therapeutics.

NCT06546995 is a Phase 1 study of Alzheimers Disease and Healthy Elderly that has completed, run by Neumora Therapeutics. The registered enrollment target is 96 participants, below the 3,926-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06546995, a Phase 1 study of Alzheimers Disease and Healthy Elderly, has completed, sponsored by Neumora Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
96 participants
Enrollment target
20
Study locations

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.

Primary Outcome

An AE is any untoward medical occurrence in a participant or clinical trial participant, temporally associated with the use of trial intervention, whether or not considered related to the trial intervention. Any AE occurring following the start of treatment or occurring before treatment but increasing in severity afterward were counted as treatment-emergent AE (TEAE). Clinically significant abnormalities in Clinical Laboratory Evaluations, ECGs, Vital Signs, Physical examinations, and Columbia S

Conditions Studied

Alzheimers Disease Healthy Elderly

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
Neumora Therapeutics

7 total trials

What the finished NCT06546995 record still lists

NCT06546995 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 96 participants, a relatively small participant target, below the 3,926-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (98% lower).

The record links to 2 conditions, with Alzheimers Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06546995 names 20 study sites across 7 states, led by Florida, California, Arizona.

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: Alzheimers Disease, Healthy Elderly.

What interventions are being tested in trial NCT06546995?

The interventions under investigation include: Placebo (DRUG), NMRA-323511 (DRUG).

Who is sponsoring clinical trial NCT06546995?

This trial is sponsored by Neumora Therapeutics, which has 7 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Alzheimers Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06546995's enrollment target sits among peer trials

96 79th of 147 higher than 69 of 147 other Alzheimers Disease trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Alzheimers Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT06546995, the US trial registry maintained by the National Library of Medicine. NCT06546995 (small enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.