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

October 26, 2010 updated by: Genentech, Inc.

A Phase I, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Intravenous MABT5102A Administered in a Single-Dose, Dose-Escalation Stage Followed by a Multidose, Parallel-Treatment Stage in Patients With Mild to Moderate Alzheimer's Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of single and multiple doses of MABT5102A
Time Frame: Through study completion or early study discontinuation
Through study completion or early study discontinuation

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics of MABT5102A after single and multiple doses
Time Frame: Through study completion or early study discontinuation
Through study completion or early study discontinuation
Immunogenicity of MABT5102A after single and multiple doses
Time Frame: Through study completion or early study discontinuation
Through study completion or early study discontinuation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Investigators

  • Study Director: Carole Ho, M.D., Genentech, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

August 15, 2008

First Submitted That Met QC Criteria

August 15, 2008

First Posted (Estimate)

August 18, 2008

Study Record Updates

Last Update Posted (Estimate)

October 27, 2010

Last Update Submitted That Met QC Criteria

October 26, 2010

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABE4427g

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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