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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01656525
First received: June 5, 2012
Last updated: September 17, 2014
Last verified: September 2014
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]
  • Pharmacokinetic parameters of Gantenerumab in plasma [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]
  • CSF/plasma ratios of Gantenerumab. [ Time Frame: Baseline, Day183 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in plasma Abeta [ Time Frame: Baseline,Day183 ] [ Designated as safety issue: No ]
  • Change from baseline in plasma and CSF tau [ Time Frame: Baseline,Day183 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT01656525     History of Changes
Other Study ID Numbers: JP22431, JapicCTI-121849
Study First Received: June 5, 2012
Last Updated: September 17, 2014
Health Authority: Ministry of Health, Labor and Welfare Board Affiliation:JAPAN

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

ClinicalTrials.gov processed this record on October 01, 2014