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NCT04639050 · ClinicalTrials.gov registry record · Phase 1

Brainshuttle AD: A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7126209 Following Intravenous Infusion in Participants With Prodromal or Mild to Moderate Alzheimer's Disease

A Phase 1 study of Alzheimers Disease, sponsored by Hoffmann-La Roche.

Active
Registry status
Phase 1
Development phase
241
Enrollment target
20
Study locations

NCT04639050 is a Phase 1 study of Alzheimers Disease that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 241 participants, below the 4,060-participant average among 142 other Alzheimers Disease trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 8 states.

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The verdict

NCT04639050, a Phase 1 study of Alzheimers Disease, is active but no longer recruiting, sponsored by Hoffmann-La Roche.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
241 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics of multiple-ascending intravenous (IV) doses of RO7126209 in participants with prodromal or mild to moderate Alzheimer's disease (AD), who are amyloid positive based on amyloid positron emission tomography (PET) scan.

Conditions Studied

Alzheimers Disease

Interventions

  • DRUG Placebo
  • DRUG RO7126209

Study Locations (20)

Florida

  • JEM Research LLC - Atlantis
  • K2 Medical Research-Winter Garden - Clermont
  • K2 Medical Research - The Villages - Lady Lake
  • K2 Medical Research, LLC - Maitland
  • Optimus U Corp - Miami
  • Charter Research - Winter Park/Orlando - Orlando
  • Advent Health Orlando - Orlando
  • Alzheimer's Research and Treatment Center - Stuart
  • Charter Research - Lady Lake/The Villages - The Villages
  • Alzheimer?s Research and Treatment Center - Wellington
  • Conquest Research, LLC - Winter Park

Georgia

  • Alzheimer's Research and Treatment Center - Columbus - Columbus
  • Center for Advanced Research & Education - Gainesville

Victoria

  • Heidelberg Repatriation Hospital - Heidelberg West
  • Alfred Hospital - Melbourne

Michigan

  • Quest Research Institute - Farmington Hills

Oregon

  • Summit Research Network Inc. - Portland

Pennsylvania

  • Abington Neurological Associates - Abington

Texas

  • Kerwin Research Center, LLC - Dallas

British Columbia

  • Richmond Clinical Trials - Richmond

Trial Details

FieldValue
Enrollment Target 241 participants
Start Date 2021-03-15
Est. Completion 2030-06-30
Phase Phase 1

Sponsor

Hoffmann-La Roche

909 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04639050

The ClinicalTrials.gov registry entry for NCT04639050 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 241 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,060-participant average among 142 other Alzheimers Disease trials with a reported enrollment target (94% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Alzheimers Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT04639050 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Florida, Georgia, Victoria.

Frequently Asked Questions

What is clinical trial NCT04639050 about?

NCT04639050 is a clinical study titled "Brainshuttle AD: A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7126209 Following Intravenous Infusion in Participants With Prodromal or Mild to Moderate Alzheimer's Disease". The purpose of this study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics of multiple-ascending intravenous (IV) doses of RO7126209 in participants with prodromal or mild to moderate Alzheimer's disease (AD), who are amyloid positive based on amyloid p...

What is the current status of trial NCT04639050?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 241 participants. The study started on 2021-03-15. Estimated completion is 2030-06-30.

What conditions does trial NCT04639050 study?

This clinical trial studies the following conditions: Alzheimers Disease.

What interventions are being tested in trial NCT04639050?

The interventions under investigation include: Placebo (DRUG), RO7126209 (DRUG).

Who is sponsoring clinical trial NCT04639050?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04639050 being conducted?

This trial has 20 study locations across Florida, Georgia, Michigan, Oregon, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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.