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A Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Anti-Abeta (MABT5102A) in Patients With Alzheimer's Disease

NCT ID: NCT00736775

Last Updated: 2010-10-27

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

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Brief Summary

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This is a Phase I, multicenter, randomized, double-blind, placebo-controlled study that will be conducted in the United States and consists of a single ascending-dose stage followed by a multidose, parallel-treatment stage. This study will be conducted in approximately 50 adult patients between 50-85 years old who have mild to moderate Alzheimer's disease.

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

Interventions

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anti-Abeta

Intravenous single and multiple doses

Intervention Type DRUG

placebo

Intravenous single and multiple doses

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of probable AD according to the NINCDS-ADRDA Criteria
* Approved AD treatments (AchE inhibitors+/-memantine) must be stable for ≥ 3 months prior to screening
* Other prescription medications must be stable for ≥ 1 month prior to screening

Exclusion Criteria

* Female patients with reproductive potential
* History or presence of any clinically significant CNS disease
* History of treatment with any protein therapeutic targeting Abeta
Minimum Eligible Age

50 Years

Maximum Eligible Age

86 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Genentech, Inc.

Principal Investigators

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Carole Ho, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Other Identifiers

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ABE4427g

Identifier Type: -

Identifier Source: org_study_id