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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01656525
First Posted: August 3, 2012
Last Update Posted: September 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chugai Pharmaceutical
  Purpose
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.

Condition Intervention Phase
Alzheimer's Disease Drug: Gantenerumab Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Chugai Pharmaceutical:

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

Secondary Outcome Measures:
  • Change from baseline in plasma Abeta [ Time Frame: Baseline,Day183 ]
  • Change from baseline in plasma and CSF tau [ Time Frame: 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 ]

Enrollment: 28
Study Start Date: June 2012
Study Completion Date: June 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Gantenerumab
75 mg subcutaneous doses every 4 weeks for 24 weeks
Experimental: 2 Drug: Gantenerumab
105 mg subcutaneous doses every 4 weeks for 24 weeks
Experimental: 3 Drug: Gantenerumab
225 mg subcutaneous doses every 4 weeks for 24 weeks
Experimental: 4 Drug: Placebo
subcutaneous doses every 4 weeks for 24 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01656525


Locations
Japan
Kansai region
Kansai, Japan
Kanto region,
Kanto, Japan
Kyushu region
Kyushu, Japan
Tokai region
Toakai, Japan
Tohoku region
Tohoku, Japan
Sponsors and Collaborators
Chugai Pharmaceutical
  More Information

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT01656525     History of Changes
Other Study ID Numbers: JP22431
JapicCTI-121849 ( Registry Identifier: JAPIC )
First Submitted: June 5, 2012
First Posted: August 3, 2012
Last Update Posted: September 19, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs