Trial record 4 of 8 for:    MABT

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

This study has been completed.
Sponsor:
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT00736775
First received: August 15, 2008
Last updated: October 26, 2010
Last verified: October 2010

August 15, 2008
October 26, 2010
August 2008
May 2010   (final data collection date for primary outcome measure)
Safety and tolerability of single and multiple doses of MABT5102A [ Time Frame: Through study completion or early study discontinuation ]
Safety and tolerability of single and multiple doses of MABT5012A [ Time Frame: Length of study ]
Complete list of historical versions of study NCT00736775 on ClinicalTrials.gov Archive Site
  • Pharmacokinetics of MABT5102A after single and multiple doses [ Time Frame: Through study completion or early study discontinuation ]
  • Immunogenicity of MABT5102A after single and multiple doses [ Time Frame: Through study completion or early study discontinuation ]
  • Pharmacokinetics of MABT5012A after single and multiple doses [ Time Frame: Length of study ]
  • Immunogenicity of MABT5012A after single and multiple doses [ Time Frame: Length of study ]
Not Provided
Not Provided
 
A Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Anti-Abeta (MABT5102A) in Patients With Alzheimer's Disease
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: anti-Abeta
    Intravenous single and multiple doses
  • Drug: placebo
    Intravenous single and multiple doses
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
Not Provided
May 2010   (final data collection date for primary outcome measure)

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
Both
50 Years to 86 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00736775
ABE4427g
Not Provided
Disclosures Group, Genentech, Inc.
Genentech
Not Provided
Study Director: Carole Ho, M.D. Genentech
Genentech
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP