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A Multiple-dose Study of Gantenerumab in Japanese Alzheimer&Apos;s Disease Patients

NCT01656525 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2014-09-19

No results posted yet for this study

Summary

Objective of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary pharmacodynamic effects of multiple doses of Gantenerumab in subject with mild to moderate AD.

Conditions

Interventions

DRUG

Gantenerumab

75 mg subcutaneous doses every 4 weeks for 24 weeks

DRUG

Gantenerumab

105 mg subcutaneous doses every 4 weeks for 24 weeks

DRUG

Gantenerumab

225 mg subcutaneous doses every 4 weeks for 24 weeks

DRUG

Placebo

subcutaneous doses every 4 weeks for 24 weeks

Sponsors & Collaborators

  • Chugai Pharmaceutical

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-03-31
Completion
2014-06-30

Countries

  • Japan

Study Locations

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Entities

Drugs
Diseases

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 NCT01656525 on ClinicalTrials.gov