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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Pharmacology Research Institute
ClinicalTrials.gov Identifier:
NCT00174525
First received: September 9, 2005
Last updated: May 8, 2012
Last verified: May 2012
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

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
Los Alamitos, California, United States, 90720
Pharmacology Research Institute
Northridge, California, United States, 91324-4625
Sponsors and Collaborators
Pharmacology Research Institute
Investigators
Principal Investigator: Daniel E. Grosz, MD Pharmacology Research Institute, Northridge
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00174525     History of Changes
Other Study ID Numbers: PRI#585
Study First Received: September 9, 2005
Last Updated: May 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pharmacology Research Institute:
Alzheimer's Caregivers
Alzheimer disease

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 23, 2013