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

Chugai Pharmaceutical28 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Alzheimer's Disease

Interventions

GantenerumabDRUG

75 mg subcutaneous doses every 4 weeks for 24 weeks

GantenerumabDRUG

105 mg subcutaneous doses every 4 weeks for 24 weeks

GantenerumabDRUG

225 mg subcutaneous doses every 4 weeks for 24 weeks

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (5)

Kansai region

Kansai, Japan

Kanto region,

Kanto, Japan

Kyushu region

Kyushu, Japan

Tokai region

Toakai, Japan

Tohoku region

Tōhoku, Japan

Outcomes

Primary Outcomes

Number of participants with Adverse Events

Time frame: 36 weeks

Pharmacokinetic parameters of Gantenerumab in plasma

Time frame: 36 weeks

CSF/plasma ratios of Gantenerumab.

Time frame: Baseline, Day183

Secondary Outcomes

Change from baseline in plasma Abeta

Time frame: Baseline,Day183

Change from baseline in plasma and CSF tau

Time frame: Baseline,Day183

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

Data from ClinicalTrials.gov

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