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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 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 4,061-participant average among 142 other Alzheimers Disease trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 7 states.

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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.

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

Sponsor

Neumora Therapeutics

7 total trials

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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, categorized as Phase 1. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,061-participant average among 142 other Alzheimers Disease trials with a reported enrollment target (98% lower). The listed sponsor is Neumora Therapeutics, which has 7 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.