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

September 17, 2014 updated by: Chugai Pharmaceutical

A Multi-center, Multiple-ascending Dose, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Safety, Tolerability and Pharmacokinetics of Gantenerumab Following Subcutaneous Injection in Japanese AD Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kansai, Japan
        • Kansai Region
      • Kanto, Japan
        • Kanto region,
      • Kyushu, Japan
        • Kyushu region
      • Toakai, Japan
        • Tokai region
      • Tohoku, Japan
        • Tohoku region

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have a diagnosis of probable AD dementia, based on NINCDS/ADRDA criteria
  • Meet DSM-IV criteria for Dementia of the Alzheimer type
  • MMSE score : 16 to 26 etc.

Exclusion Criteria:

  • Meet the exclusion criteria of MRI at screening.
  • A history of significant neurodegenerative diseases or dementia other than Alzheimer's disease.

etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
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
EXPERIMENTAL: 2
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
EXPERIMENTAL: 3
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
EXPERIMENTAL: 4
Drug: Placebo
subcutaneous doses every 4 weeks for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with Adverse Events
Time Frame: 36 weeks
36 weeks
Pharmacokinetic parameters of Gantenerumab in plasma
Time Frame: 36 weeks
36 weeks
CSF/plasma ratios of Gantenerumab.
Time Frame: Baseline, Day183
Baseline, Day183

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in plasma Abeta
Time Frame: Baseline,Day183
Baseline,Day183
Change from baseline in plasma and CSF tau
Time Frame: Baseline,Day183
Baseline,Day183
Change from baseline in Mini-Mental State Examination (MMSE) and Alzheimer's disease assessment scale cognitive behaviors (ADAS-Cog).
Time Frame: Baseline,Day85, 197, 253
Baseline,Day85, 197, 253

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chugai Pharmaceutical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (ACTUAL)

March 1, 2014

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

June 5, 2012

First Submitted That Met QC Criteria

August 1, 2012

First Posted (ESTIMATE)

August 3, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 19, 2014

Last Update Submitted That Met QC Criteria

September 17, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JP22431
  • JapicCTI-121849 (REGISTRY: JAPIC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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