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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Pharmacology Research Institute.
Recruitment status was  Active, not recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 31, 2014