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Randomized Safety, Tolerability and Pilot Efficacy of AN-1792 in Alzheimer's Disease

This study has been terminated.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT00021723
First received: August 2, 2001
Last updated: September 22, 2009
Last verified: November 2001
August 2, 2001
September 22, 2009
September 2001
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Complete list of historical versions of study NCT00021723 on ClinicalTrials.gov Archive Site
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Randomized Safety, Tolerability and Pilot Efficacy of AN-1792 in Alzheimer's Disease
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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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Alzheimer's Disease
Biological: AN-1792 also known as AIP-001
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
375
September 2003
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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.
Sexes Eligible for Study: All
50 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00021723
AN-1792-201
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VP Clinical Development, JANSSEN Alzheimer Immunotherapy Research & Development, LLC
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
November 2001

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