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A Multiple-dose Study of Gantenerumab in Japanese Alzheimer's Disease Patients

This study is currently recruiting participants.
Verified October 2012 by Chugai Pharmaceutical
Sponsor:
Information provided by (Responsible Party):
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01656525
First received: June 5, 2012
Last updated: October 1, 2012
Last verified: October 2012
History of Changes
  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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 28
Study Start Date: June 2012
Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01656525

Contacts
Contact: Akira Chiba clinical-trials@chugai-pharm.co.jp

Locations
Japan
Kansai region Recruiting
Kansai, Japan
Contact: Akira Chiba         clinical-trials@chugai-pharm.co.jp    
Kanto region, Recruiting
Kanto, Japan
Contact: Akira Chiba         clinical-trials@chugai-pharm.co.jp    
Kyushu region Recruiting
Kyushu, Japan
Contact: Akira Chiba         clinical-trials@chugai-pharm.co.jp    
Tokai region Recruiting
Toakai, Japan
Contact: Akira Chiba         clinical-trials@chugai-pharm.co.jp    
Tohoku region Recruiting
Tohoku, Japan
Contact: Akira Chiba         clinical-trials@chugai-pharm.co.jp    
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: October 1, 2012
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

ClinicalTrials.gov processed this record on May 16, 2013