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NCT02670083 · ClinicalTrials.gov registry record · Phase 3

A Study Evaluating the Efficacy and Safety of Crenezumab Versus Placebo in Participants With Prodromal to Mild Alzheimer's Disease (AD).

A Phase 3 study, sponsored by Hoffmann-La Roche.

Terminated
Registry status
Phase 3
Development phase
813
Enrollment target

NCT02670083 is a Phase 3 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 813 participants.

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The verdict

NCT02670083, a Phase 3 study, was terminated before completion, sponsored by Hoffmann-La Roche.

TERMINATED
Registry status
Phase 3
Development phase
813 participants
Enrollment target

Study Summary

This randomized, double-blind, placebo-controlled, parallel group study will evaluate the efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD. Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab or placebo every 4 weeks (Q4W) for 100 weeks. The final efficacy and safety assessment will be performed 52 weeks after the last crenezumab dose. Participants will then have the option to enter the Open Label Extension (OLE) study if eligible. Participants who do not enter the OLE study will have additional follow-up visits at 16 and 52 weeks after the last dose, primarily for safety and also for limited efficacy assessments.

Interventions

  • DRUG Placebo
  • DRUG Crenezumab

Trial Details

FieldValue
Enrollment Target 813 participants
Start Date 2016-03-22
Est. Completion 2019-05-31
Phase Phase 3

Sponsor

Hoffmann-La Roche

909 total trials

What the Registry Record Tells You About NCT02670083

The ClinicalTrials.gov registry entry for NCT02670083 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 813 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02670083 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02670083 about?

NCT02670083 is a clinical study titled "A Study Evaluating the Efficacy and Safety of Crenezumab Versus Placebo in Participants With Prodromal to Mild Alzheimer's Disease (AD).". This randomized, double-blind, placebo-controlled, parallel group study will evaluate the efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD. Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab or placebo every 4 weeks...

What is the current status of trial NCT02670083?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 813 participants. The study started on 2016-03-22. Estimated completion is 2019-05-31.

What interventions are being tested in trial NCT02670083?

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

Who is sponsoring clinical trial NCT02670083?

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

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.