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Completed

NCT Number: NCT00736775

A Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Anti-Abeta (MABT5102A) in Patients With 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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–86 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

anti-Abeta

Drug

Intravenous single and multiple doses

Placebo

Drug

Intravenous single and multiple doses

Primary outcomes

  1. Safety and tolerability of single and multiple doses of MABT5102A

    Time frame: Through study completion or early study discontinuation

Secondary outcomes

  1. Pharmacokinetics of MABT5102A after single and multiple doses

    Time frame: Through study completion or early study discontinuation

  2. Immunogenicity of MABT5102A after single and multiple doses

    Time frame: Through study completion or early study discontinuation

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2010
First posted
Aug 18, 2008
Registry last updated
Oct 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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