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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

June 5, 2012
September 17, 2014
June 2012
March 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01656525 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Multiple-dose Study of Gantenerumab in Japanese Alzheimer&Apos;s Disease Patients
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Alzheimer's Disease
  • 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
  • Experimental: 1
    Intervention: Drug: Gantenerumab
  • Experimental: 2
    Intervention: Drug: Gantenerumab
  • Experimental: 3
    Intervention: Drug: Gantenerumab
  • Experimental: 4
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
June 2014
March 2014   (final data collection date for primary outcome measure)

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.

Both
50 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01656525
JP22431, JapicCTI-121849
No
Chugai Pharmaceutical
Chugai Pharmaceutical
Not Provided
Not Provided
Chugai Pharmaceutical
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP