A Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of MABT5102A in Patients With Alzheimer's Disease - Full Text View

Sponsored by:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00736775

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: MABT5102A Drug: placebo	Phase I

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
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

Further study details as provided by Genentech:

Primary Outcome Measures:

Safety and tolerability of single and multiple doses of MABT5102A [ Time Frame: Length of study ]

Secondary Outcome Measures:

Pharmacokinetics of MABT5102A after single and multiple doses [ Time Frame: Length of study ]
Immunogenicity of MABT5102A after single and multiple doses [ Time Frame: Length of study ]

Estimated Enrollment:	50
Study Start Date:	August 2008

Intervention Details:

Intravenous single and multiple doses

Eligibility

Ages Eligible for Study:	50 Years to 85 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

Contacts

Contact: Kathleen Winson

winson.kathleen@gene.com

Locations

United States, Arizona
Pivotal Research Center	Recruiting
Peoria, Arizona, United States, 0000853381
United States, Missouri
Millennium Psychiatric Assoc	Recruiting
St. Louis, Missouri, United States, 63044
Contact: Amanda Smith 314-298-0001 aamsmpa@sbcglobal.net
United States, New Jersey
Memory Enhancement Center	Recruiting
Long Branch, New Jersey, United States, 07740

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Carole Ho, M.D.

Genentech

More Information

Responsible Party:	Genentech, Inc. ( Clinical Trials Posting Group )
Study ID Numbers:	ABE4427g
Study First Received:	August 15, 2008
Last Updated:	August 22, 2008
ClinicalTrials.gov Identifier:	NCT00736775
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

AD
Alzheimer's
Alzheimers

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases

Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on January 14, 2009