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

Chugai Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: Gantenerumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01656525

JapicCTI-121849 (Registry Identifier)

JP22431

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No 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 exclusion criteria of MRI at screening.
• A history of significant neurodegenerative diseases or dementia other than Alzheimer's disease.

etc.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 4 patient groups

1

Experimental group

Treatment:

Drug: Gantenerumab

Drug: Gantenerumab

Drug: Gantenerumab

2

Experimental group

Treatment:

Drug: Gantenerumab

Drug: Gantenerumab

Drug: Gantenerumab

3

Experimental group

Treatment:

Drug: Gantenerumab

Drug: Gantenerumab

Drug: Gantenerumab

4

Experimental group

Treatment:

Drug: Placebo