- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00174525
Safety Study of Passive Immunization for Patients With Mild to Moderate Alzheimer's Disease
May 8, 2012 updated by: Pharmacology Research Institute
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.
Study Overview
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Alamitos, California, United States, 90720
- Pharmacology Research Institute
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Northridge, California, United States, 91324-4625
- Pharmacology Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Safety assessments
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Secondary Outcome Measures
Outcome Measure |
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Blood levels of administered study drug
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Cognitive and functional assessments
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Daniel E. Grosz, MD, Pharmacology Research Institute, Northridge
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2005
Study Completion
April 1, 2008
Study Registration Dates
First Submitted
September 9, 2005
First Submitted That Met QC Criteria
September 9, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Estimate)
May 9, 2012
Last Update Submitted That Met QC Criteria
May 8, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRI#585
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on AAB-001
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JANSSEN Alzheimer Immunotherapy Research & Development...TerminatedAlzheimer's DiseaseUnited States
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JANSSEN Alzheimer Immunotherapy Research & Development...PfizerCompleted
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PfizerTerminatedAlzheimer DiseaseUnited States, Spain, Belgium, France, Australia, Japan, Netherlands, Portugal, Croatia, United Kingdom, Germany, Austria, Sweden, Slovakia, Serbia, Argentina, Italy, Chile, Finland, New Zealand, South Africa, Switzerland, Mexico, Poland
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PfizerTerminatedAlzheimer DiseaseCanada, Finland, United States, Spain, Belgium, France, Japan, Netherlands, Portugal, Australia, Croatia, United Kingdom, Italy, Argentina, Germany, Slovakia, Serbia, Russian Federation, Chile, New Zealand, South Africa, Switzerland, Mexi... and more
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PfizerTerminatedAlzheimer DiseaseUnited States, Spain, France, Japan, New Zealand, Belgium, Portugal, Netherlands, Argentina, United Kingdom, Australia, Slovakia, Poland, Chile, Finland, Italy, South Africa, Sweden, Switzerland
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JANSSEN Alzheimer Immunotherapy Research & Development...PfizerCompletedAlzheimer's DiseaseUnited States, Germany, Canada, Austria
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JANSSEN Alzheimer Immunotherapy Research & Development...PfizerCompletedAlzheimer's DiseaseUnited States
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PfizerTerminatedAlzheimer DiseaseAustralia, France, Finland, Portugal, Spain, United Kingdom, Poland, Japan, Italy, Belgium, Switzerland, Netherlands, Chile, Slovakia, Sweden, New Zealand, South Africa
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PfizerJANSSEN Alzheimer Immunotherapy Research & Development, LLCCompletedAlzheimer's DiseaseKorea, Republic of, United States
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PfizerJANSSEN Alzheimer Immunotherapy Research & Development, LLCCompletedAlzheimer's DiseaseUnited States, Korea, Republic of