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Clinical Trials/NCT00736775
NCT00736775
Completed
Phase 1

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

Genentech, Inc.0 sites56 target enrollmentAugust 2008
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ConditionsAlzheimer's Disease
Drugsanti-Abetaplacebo

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Alzheimer's Disease
Sponsor
Genentech, Inc.
Enrollment
56
Primary Endpoint
Safety and tolerability of single and multiple doses of MABT5102A
Status
Completed
Last Updated
15 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
August 2008
End Date
May 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Safety and tolerability of single and multiple doses of MABT5102A

Time Frame: Through study completion or early study discontinuation

Secondary Outcomes

  • Pharmacokinetics of MABT5102A after single and multiple doses(Through study completion or early study discontinuation)
  • Immunogenicity of MABT5102A after single and multiple doses(Through study completion or early study discontinuation)

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