Back to resultsA Multiple-dose Study of Gantenerumab in Japanese Alzheimer&Apos;s Disease Patients
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Gantenerumab
Gantenerumab
Gantenerumab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility 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.
Sites / Locations
- Kansai region
- Kanto region,
- Kyushu region
- Tokai region
- Tohoku region
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
1
2
3
4
Arm Description
Outcomes
Primary Outcome Measures
Number of participants with Adverse Events
Pharmacokinetic parameters of Gantenerumab in plasma
CSF/plasma ratios of Gantenerumab.
Secondary Outcome Measures
Change from baseline in plasma Abeta
Change from baseline in plasma and CSF tau
Change from baseline in Mini-Mental State Examination (MMSE) and Alzheimer's disease assessment scale cognitive behaviors (ADAS-Cog).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01656525
Brief Title
A Multiple-dose Study of Gantenerumab in Japanese Alzheimer&Apos;s Disease Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chugai Pharmaceutical
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Gantenerumab
Intervention Description
75 mg subcutaneous doses every 4 weeks for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Gantenerumab
Intervention Description
105 mg subcutaneous doses every 4 weeks for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Gantenerumab
Intervention Description
225 mg subcutaneous doses every 4 weeks for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
subcutaneous doses every 4 weeks for 24 weeks
Primary Outcome Measure Information:
Title
Number of participants with Adverse Events
Time Frame
36 weeks
Title
Pharmacokinetic parameters of Gantenerumab in plasma
Time Frame
36 weeks
Title
CSF/plasma ratios of Gantenerumab.
Time Frame
Baseline, Day183
Secondary Outcome Measure Information:
Title
Change from baseline in plasma Abeta
Time Frame
Baseline,Day183
Title
Change from baseline in plasma and CSF tau
Time Frame
Baseline,Day183
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Kansai region
City
Kansai
Country
Japan
Facility Name
Kanto region,
City
Kanto
Country
Japan
Facility Name
Kyushu region
City
Kyushu
Country
Japan
Facility Name
Tokai region
City
Toakai
Country
Japan
Facility Name
Tohoku region
City
Tohoku
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Multiple-dose Study of Gantenerumab in Japanese Alzheimer&Apos;s Disease Patients
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