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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

September 9, 2005
May 8, 2012
April 2005
Not Provided
Safety assessments
Same as current
Complete list of historical versions of study NCT00174525 on ClinicalTrials.gov Archive Site
  • Blood levels of administered study drug
  • Cognitive and functional assessments
Same as current
Not Provided
Not Provided
 
Safety Study of Passive Immunization for Patients With Mild to Moderate Alzheimer's Disease
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

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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Alzheimer's Disease
Drug: AAB-001
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
Not Provided
April 2008
Not Provided

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
Both
50 Years to 85 Years
Not Provided
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00174525
PRI#585
Not Provided
Not Provided
Pharmacology Research Institute
Not Provided
Principal Investigator: Daniel E. Grosz, MD Pharmacology Research Institute, Northridge
Pharmacology Research Institute
May 2012

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