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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00736775
• Other study ID #: ABE4427g
• Status: Completed
• Phase: Phase 1
• First received: August 15, 2008
• Last updated: October 26, 2010
• Start date: August 2008

Study information

• Verified date: October 2010
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 86 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• anti-Abeta
Intravenous single and multiple doses
• placebo
Intravenous single and multiple doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of single and multiple doses of MABT5102A		Through study completion or early study discontinuation
Secondary	Pharmacokinetics of MABT5102A after single and multiple doses		Through study completion or early study discontinuation
Secondary	Immunogenicity of MABT5102A after single and multiple doses		Through study completion or early study discontinuation