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

NCT02670083 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 813

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 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.

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
2016-03-22
Primary Completion
2019-05-31
Completion
2019-05-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • Costa Rica
  • Croatia
  • Czechia
  • Denmark
  • Finland
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Italy
  • Japan
  • Lithuania
  • Mexico
  • Poland
  • Portugal
  • Russia
  • Slovenia
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

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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 NCT02670083 on ClinicalTrials.gov