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

NCT ID: NCT01656525

Last Updated: 2014-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-06-30

Brief Summary

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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

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Group Type EXPERIMENTAL

Gantenerumab

Intervention Type DRUG

75 mg subcutaneous doses every 4 weeks for 24 weeks

2

Group Type EXPERIMENTAL

Gantenerumab

Intervention Type DRUG

105 mg subcutaneous doses every 4 weeks for 24 weeks

3

Group Type EXPERIMENTAL

Gantenerumab

Intervention Type DRUG

225 mg subcutaneous doses every 4 weeks for 24 weeks

4

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

subcutaneous doses every 4 weeks for 24 weeks

Interventions

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Gantenerumab

75 mg subcutaneous doses every 4 weeks for 24 weeks

Intervention Type DRUG

Gantenerumab

105 mg subcutaneous doses every 4 weeks for 24 weeks

Intervention Type DRUG

Gantenerumab

225 mg subcutaneous doses every 4 weeks for 24 weeks

Intervention Type DRUG

Placebo

subcutaneous doses every 4 weeks for 24 weeks

Intervention Type DRUG

Eligibility Criteria

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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

* A history of significant neurodegenerative diseases or dementia other than Alzheimer's disease.

etc.
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chugai Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kansai region

Kansai, , Japan

Site Status

Kanto region,

Kanto, , Japan

Site Status

Kyushu region

Kyushu, , Japan

Site Status

Tokai region

Toakai, , Japan

Site Status

Tohoku region

Tōhoku, , Japan

Site Status

Countries

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Japan

Other Identifiers

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JapicCTI-121849

Identifier Type: REGISTRY

Identifier Source: secondary_id

JP22431

Identifier Type: -

Identifier Source: org_study_id

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