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

History of Changes

Tracking Information
First Received Date ^ICMJE	August 2, 2001
Last Updated Date	September 22, 2009
Start Date ^ICMJE	September 2001
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00021723 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Randomized Safety, Tolerability and Pilot Efficacy of AN-1792 in Alzheimer's Disease
Official Title ^ICMJE	Not Provided
Brief Summary	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.
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 ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Alzheimer's Disease
Intervention ^ICMJE	Biological: AN-1792 also known as AIP-001
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	375
Completion Date	September 2003
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	50 Years to 85 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00021723
Other Study ID Numbers ^ICMJE	AN-1792-201
Has Data Monitoring Committee	Not Provided
Responsible Party	VP Clinical Development, JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Study Sponsor ^ICMJE	JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Collaborators ^ICMJE	Wyeth is now a wholly owned subsidiary of Pfizer
Investigators ^ICMJE	Not Provided
Information Provided By	JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Verification Date	November 2001
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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