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

Purpose

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.

Condition	Intervention	Phase
Alzheimer's Disease	Biological: AN-1792 also known as AIP-001	Phase II

Genetics Home Reference related topics:

Alzheimer disease

MedlinePlus related topics:

Alzheimer's Disease

ChemIDplus related topics:

AN-1792

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Elan Pharmaceuticals:

Estimated Enrollment:	375
Study Start Date:	September 2001
Estimated Study Completion Date:	September 2003

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.

Eligibility

Ages Eligible for Study:	50 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00021723

Locations


United States, Arizona
	Pivotal Research Centers
	Peoria, Arizona, United States, 85381
	21st Century Neurology
	Phoenix, Arizona, United States, 85013

United States, California
	Pharmacology Research Institute
	Northridge, California, United States, 91324-4625
	California Clinical Trials
	Beverly Hills, California, United States, 90211
	UCSD Medical Center
	La Jolla, California, United States, 92093

United States, Florida
	Baumel-Eisner Neuromedical Institute
	Ft. Lauderdale, Florida, United States, 33321
	Baumel-Eisner Neuromedical Institute
	Bay Harbor Islands, Florida, United States, 33154
	Baumel-Eisner Neuromedical Institute
	Boca Raton, Florida, United States, 33486

United States, Minnesota
	Mayo Clinic
	Rochester, Minnesota, United States, 55905

United States, Oklahoma
	Clinical Pharmaceutical Trials, Inc.
	Tulsa, Oklahoma, United States, 74104

United States, Texas
	Baylor College of Medicine
	Houston, Texas, United States, 77030

Sponsors and Collaborators

Elan Pharmaceuticals

Wyeth

More Information

Study ID Numbers:	AN-1792-201
First Received:	August 2, 2001
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00021723
Health Authority:	United States: Food and Drug Administration

Keywords provided by Elan Pharmaceuticals:

Alzheimer's

AN-1792

AIP-001

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders

Mental Disorders

Alzheimer Disease

Central Nervous System Diseases

Neurodegenerative Diseases

Brain Diseases

Dementia

Cognition Disorders

Delirium

Additional relevant MeSH terms:

Nervous System Diseases

Tauopathies

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	Elan Pharmaceuticals Wyeth
Information provided by:	Elan Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00021723