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A Study of Crenezumab in Participants With Mild to Moderate Alzheimer Disease

NCT02353598 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2019-07-24

No results posted yet for this study

Summary

This randomized, placebo-controlled, double-blind, parallel-arm study will evaluate the safety and tolerability of at least two dose levels of intravenous (IV) crenezumab in 24-72 participants with mild to moderate Alzheimer disease (AD) (mini-mental state examination \[MMSE\] 18 to 28 points, inclusive). An optional open-label extension (OLE) will be offered after the completion of initial double-blind stage.

Conditions

  • Alzheimer Disease

Interventions

DRUG

Crenezumab dose level 1

Participants will receive crenezumb dose level 1 IV infusion once every 4 weeks up to Week 13 in double-blind treatment window or up to Week 61 in optional OLE window.

DRUG

Crenezumab dose level 2

Participants will receive crenezumb dose level 2 IV infusion once every 4 weeks up to Week 13 in double-blind treatment window or up to Week 61 in optional OLE window.

DRUG

Crenezumb dose level 3

Participants will receive crenezumb dose level 3 IV infusion once every 4 weeks upto Week 13 in double-blind treatment window or up to Week 61 in optional OLE window.

DRUG

Placebo

Participants will receive placebo matched to crenezumab IV infusion once every 4 weeks upto Week 13 in double-blind treatment window.

Sponsors & Collaborators

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-02-26
Primary Completion
2016-11-30
Completion
2019-03-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT02353598 on ClinicalTrials.gov