AAB-001 (Bapineuzumab) Open-Label, Long-Term Extension Study in Patients With Mild to Moderate Alzheimer's Disease - Full Text View

Sponsored by:	Elan Pharmaceuticals
Information provided by:	Elan Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00606476

Purpose

This is a multicenter, open-label, long-term extension study in male and female patients with mild to moderate Alzheimer's Disease (AD) who must have completed one of the following studies: AAB-001-201, AAB-001-202, or AAB-001-102. All patients enrolled in Study AAB-001-251 will receive infusions of AAB-001 (bapineuzumab), including patients randomized to placebo in Study 201, 202, and 102. Approximately 30 study sites in the US, 1 site in Finland, and 2 sites in the UK will be involved. Each patient's participation may vary from 3 months up to 24 months depending on the date of enrollment in this study. AAB-001 (bapineuzumab) is a humanized monoclonal antibody, which binds to and potentially clears beta amyloid peptide, and is designed to provide antibodies to beta amyloid directly to the patient.

Condition	Intervention	Phase
Alzheimer's Disease	Drug: Bapineuzumab (AAB-001)	Phase II

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Parallel Assignment
Official Title:	A Phase II, Multicenter, Open-Label, Long-Term Treatment Study to Determine the Safety, Tolerability, and Efficacy of AAB-001 (ELN115727;Bapineuzumab) in Patients With Alzheimer's Disease Who Participated in Study AAB-001-201, AAB-001-202, or AAB-001-102

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Bapineuzumab

U.S. FDA Resources

Further study details as provided by Elan Pharmaceuticals:

Primary Outcome Measures:

The incidence and severity of treatment-emergent adverse events (TEAEs); [ Time Frame: 3-24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinically important changes in safety assessment results (e.g. vital signs, weight, clinical laboratory tests, electrocardiograms [ECGs], brain magnetic resonance imaging [MRIs], physical and neurological examinations, and infusion site assessments) [ Time Frame: 3-24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	220
Study Start Date:	December 2006
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Bapineuzumab (AAB-001)
2: Active Comparator	Drug: Bapineuzumab (AAB-001)
3: Active Comparator	Drug: Bapineuzumab (AAB-001)
4: Active Comparator	Drug: Bapineuzumab (AAB-001)

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Must have completed study 201 or study 202 Visit 22 (Week 78) or study 102 Visit 11(Week 16)
Baseline brain magnetic resonance imaging (MRI) scan must be of sufficient quality to evaluate patient safety
Diagnosis of Probable Alzheimer's disease according to NINCDS/ADRDA criteria
Caregiver able to attend all clinic visits with patient

Exclusion Criteria:

Significant neurological disease other than AD
Major psychiatric disorder
Significant systemic illness
History of stroke, seizure, or autoimmune disease
History myocardial infarction within the last 2 years
Smoking greater than 20 cigarettes per day
Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications
Prior treatment experimental immunotherapeutics or vaccines for AD
Women of childbearing potential
Presence of pacemakers, CSF shunts, or foreign metal objects in the eyes, skin or body

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Elan Pharmaceuticals, Inc. ( Ivan Lieberburg )
Study ID Numbers:	AAB-001-251
Study First Received:	January 11, 2008
Last Updated:	May 15, 2008
ClinicalTrials.gov Identifier:	NCT00606476 History of Changes
Health Authority:	United States: Food and Drug Administration

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:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases

Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on September 03, 2009