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

NCT03114657 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 806

Last updated 2020-07-16

Study results available
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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 primary efficacy assessment will be performed at 105 weeks. The participants who do not enter open-label extension will enter for a long term follow-up period for up to 52 weeks after the last crenezumab dose (Week 153).

Conditions

Interventions

DRUG

Crenezumab

Crenezumab was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above.

DRUG

Placebo

Placebo was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-29
Primary Completion
2019-06-11
Completion
2019-06-11
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • China
  • Denmark
  • Estonia
  • France
  • Germany
  • Israel
  • Italy
  • Japan
  • Norway
  • Peru
  • Poland
  • Portugal
  • Russia
  • Serbia
  • South Africa
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03114657 on ClinicalTrials.gov