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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01656525

Enrollment

Registered

2012-08-03

Start date

2012-06-30

Completion date

2014-06-30

Last updated

2014-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

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.

Interventions

DRUGGantenerumab

75 mg subcutaneous doses every 4 weeks for 24 weeks

DRUGPlacebo

subcutaneous doses every 4 weeks for 24 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of participants with Adverse Events	36 weeks
Pharmacokinetic parameters of Gantenerumab in plasma	36 weeks
CSF/plasma ratios of Gantenerumab.	Baseline, Day183

Secondary

Measure	Time frame
Change from baseline in plasma Abeta	Baseline,Day183
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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026