Safety Study of Passive Immunization for Patients With Mild to Moderate Alzheimer's Disease

This study is ongoing, but not recruiting participants.

Sponsored by:	Pharmacology Research Institute
Information provided by:	Pharmacology Research Institute
ClinicalTrials.gov Identifier:	NCT00174525

Purpose

This research study will assess whether AAB-001 is safe, well tolerated and effective for use in patients with Alzheimer's Disease. AAB-001 is a new drug that is not available outside this study. AAB-001 is an antibody (a type of protein usually produced by white blood cells to destroy other substances in the body). In Alzheimer's disease a protein called amyloid gathers in the brain and is thought to cause symptoms like memory loss and confusion. It is hoped that AAB-001 will attach to the amyloid protein in your brain and help your body to remove it.

Condition	Intervention	Phase
Alzheimer's Disease	Drug: AAB-001	Phase II

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, Placebo Control, Parallel Assignment, Safety Study
Official Title:	A Phase IIA, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, and Immunogenicity Trial of AAB-001 in Patients With Mild to Moderate AD

Further study details as provided by Pharmacology Research Institute:

Primary Outcome Measures:

Safety assessments

Secondary Outcome Measures:

Blood levels of administered study drug
Cognitive and functional assessments

Study Start Date:	April 2005
Estimated Study Completion Date:	April 2008

Eligibility

Ages Eligible for Study:	50 Years to 85 Years
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Diagnosis of probable AD
Age from 50 to 85 years, inclusive
Rosen Modified Hachinski ischemic score less than or equal to 4
Magnetic Resonance Imaging (MRI) scan consistent with the diagnosis of AD
Fluency in English
Stable doses of medications

Exclusion Criteria:

Significant neurological disease other than AD
Major psychiatric disorder
Significant systemic illness
History of stroke or seizure
Weight greater than 120kg (264 lbs.)
History of autoimmune disease
Smoking more than 20 cigarettes per day
Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications
Prior treatment with experimental immunotherapeutics or vaccines for AD
Presence of pacemakers or foreign metal objects in the eyes, skin, or body

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00174525

Locations

United States, California
Pharmacology Research Institute
Northridge, California, United States, 91324-4625
Pharmacology Research Institute
Los Alamitos, California, United States, 90720

Sponsors and Collaborators

Pharmacology Research Institute

Investigators

Principal Investigator:

Daniel E. Grosz, MD

Pharmacology Research Institute, Northridge

More Information

Study ID Numbers:	PRI#585
Study First Received:	September 9, 2005
Last Updated:	September 6, 2006
ClinicalTrials.gov Identifier:	NCT00174525
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pharmacology Research Institute:

Alzheimer's Caregivers
Alzheimer disease

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 16, 2009