- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00021723
Randomized Safety, Tolerability and Pilot Efficacy of AN-1792 in Alzheimer's Disease
September 22, 2009 updated by: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
A multi-center, double-blind, placebo-controlled out-patient, safety, tolerability, and pilot efficacy study of intramuscular AN-1792 in patients with mild to moderate Alzheimer's disease.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
The study will enroll approximately 375 patients with mild to moderate Alzheimer's disease at investigational sites in the United States and Europe.
Patients will receive either AN-1792 or placebo, and they will be evaluated using standard clinical assessments of cognition and memory as well as experimental surrogate markers of Alzheimer's disease pathology.
The goal of the study is to evaluate the clinical impact of eliciting an immune response (formation of antibodies) to the A-beta peptide in patients with Alzheimer's disease.
Study Type
Interventional
Enrollment
375
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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Arizona
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Peoria, Arizona, United States, 85381
- Pivotal Research Centers
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Phoenix, Arizona, United States, 85013
- 21st Century Neurology
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California
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Beverly Hills, California, United States, 90211
- California Clinical Trials
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La Jolla, California, United States, 92093
- UCSD Medical Center
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Northridge, California, United States, 91324-4625
- Pharmacology Research Institute
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Florida
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Bay Harbor Islands, Florida, United States, 33154
- Baumel-Eisner Neuromedical Institute
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Boca Raton, Florida, United States, 33486
- Baumel-Eisner Neuromedical Institute
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Ft. Lauderdale, Florida, United States, 33321
- Baumel-Eisner Neuromedical Institute
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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Oklahoma
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Tulsa, Oklahoma, United States, 74104
- Clinical Pharmaceutical Trials, Inc.
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Texas
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Houston, Texas, United States, 77030
- Baylor College of Medicine
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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
No
Genders Eligible for Study
All
Description
Mild to moderate Alzheimer's disease.
Ability to cooperate with MRI scanning and neuropsychological testing.
Live at home or in the community and a caregiver capable of accompanying the patient on all clinic visits and visiting the patient at least 5 times per week.
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
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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
September 1, 2001
Study Completion
September 1, 2003
Study Registration Dates
First Submitted
August 2, 2001
First Submitted That Met QC Criteria
August 3, 2001
First Posted (Estimate)
August 6, 2001
Study Record Updates
Last Update Posted (Estimate)
September 24, 2009
Last Update Submitted That Met QC Criteria
September 22, 2009
Last Verified
November 1, 2001
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AN-1792-201
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.
Clinical Trials on Alzheimer's Disease
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