A Multiple-dose Study of Gantenerumab in Japanese Alzheimer&Apos;s Disease Patients
- Registration Number
- NCT01656525
- Lead Sponsor
- Chugai Pharmaceutical
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 4 Placebo - 2 Gantenerumab - 1 Gantenerumab - 3 Gantenerumab -
- Primary Outcome Measures
Name Time Method Pharmacokinetic parameters of Gantenerumab in plasma 36 weeks Number of participants with Adverse Events 36 weeks CSF/plasma ratios of Gantenerumab. Baseline, Day183
- Secondary Outcome Measures
Name Time Method Change from baseline in plasma and CSF tau Baseline,Day183 Change from baseline in Mini-Mental State Examination (MMSE) and Alzheimer's disease assessment scale cognitive behaviors (ADAS-Cog). Baseline,Day85, 197, 253 Change from baseline in plasma Abeta Baseline,Day183
Trial Locations
- Locations (5)
Kansai region
🇯🇵Kansai, Japan
Kanto region,
🇯🇵Kanto, Japan
Kyushu region
🇯🇵Kyushu, Japan
Tokai region
🇯🇵Toakai, Japan
Tohoku region
🇯🇵Tohoku, Japan