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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
 Drug: anti-Abeta
Drug: placebo
 Phase 1

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:
  • Safety and tolerability of single and multiple doses of MABT5102A [ Time Frame: Through study completion or early study discontinuation ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 56
Study Start Date: August 2008
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: anti-Abeta
    Intravenous single and multiple doses
    Drug: placebo
    Intravenous single and multiple doses
  Eligibility

Ages Eligible for Study:   50 Years to 86 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00736775

Sponsors and Collaborators
Genentech
Investigators
Study Director: Carole Ho, M.D. Genentech
  More Information

No publications provided

Responsible Party: Disclosures Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00736775     History of Changes
Other Study ID Numbers: ABE4427g
Study First Received: August 15, 2008
Last Updated: October 26, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
AD
Alzheimer's
Alzheimers

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013