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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT00606476
First received: January 11, 2008
Last updated: October 30, 2013
Last verified: August 2012
  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 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 and 102. Approximately 30 study sites in the US will be involved. Each patient's participation may vary from 3 months up to 84 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 2

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

Resource links provided by NLM:


Further study details as provided by JANSSEN Alzheimer Immunotherapy Research & Development, LLC:

Primary Outcome Measures:
  • To assess the safety and tolerability of long-term treatment of bapineuzumab in subjects with AD. [ Time Frame: 3-84 months ] [ Designated as safety issue: No ]
    • The incidence and severity of treatment-emergent adverse events (TEAEs);
    • Clinically important changes in safety assessment results (including, as appropriate, vital signs, weight, clinical laboratory tests, electrocardiograms [ECGs], brain magnetic resonance imaging [MRIs], physical and neurological examinations, and infusion site assessments).


Secondary Outcome Measures:
  • To evaluate the efficacy of long-term treatment of bapineuzumab in subjects with AD. [ Time Frame: 3-84 months ] [ Designated as safety issue: No ]

    Change from Visit 2 (Pre-Day 1) and Visit 22 (Week 78) of Study AAB-001-201 for the following scales:

    • Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog)
    • Disability Assessment for Dementia (DAD)
    • Mini Mental State Examination (MMSE)

    Change from Study AAB-001-251Visit 1 (Day 1) for the following scales:

    • Dependence Scale
    • Resource Utilization in Dementia (RUD) Lite

    Change from Study 251 Screening Visit for the following scales for subjects entering from Study AAB-001-102 (US):

    • ADAS-Cog
    • DAD
    • MMSE


Enrollment: 194
Study Start Date: December 2006
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
0.15 mg/kg active bapineuzumab
Drug: Bapineuzumab (AAB-001)
IV q13w
Other Name: AAB-001
Active Comparator: 2
0.5 mg/kg active bapineuzumab
Drug: Bapineuzumab (AAB-001)
IV q13w
Other Name: AAB-001
Active Comparator: 3
1.0 mg/kg active bapineuzmab
Drug: Bapineuzumab (AAB-001)
IV q13w
Other Name: AAB-001

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

A subject must meet ALL of the following criteria to be considered for enrollment into this study:

  1. Signed and dated written informed consent obtained from the subject and/or the subject's caregiver in accordance with the local regulations.
  2. Subjects must have completed Study 201 Visit 22 (Week 78), or Study 102 Visit 11 (Week 16).
  3. Magnetic resonance imaging scan of sufficient quality for the Radiologist to evaluate subject safety from Study 201 Visit 21 (Week 71), or Study 251 Screening Visit for subjects from Study 102.
  4. Lives at home with appropriate caregiver capable of accompanying the subject on all clinic visits, or community dwelling with caregiver capable of accompanying the subject on all clinic visits and visiting with the subject approximately five times per week for the duration of the study.
  5. In the opinion of the investigator, the subject and the caregiver will be compliant.

Exclusion Criteria:

ANY one of the following will exclude a subject from being enrolled into the study:

  1. Significant neurological disease other than AD that may affect cognition.
  2. Screening visit brain MRI scan (ie, Study 201 Visit 21 (Week 71), or for Study 102, the Study 251 Screening Visit) indicative of any other significant abnormality including but not limited to multiple microhemorrhages or evidence of a single prior hemorrhage >1 cm3, multiple lacunar infarcts or evidence of a single prior infarct >1 cm3, evidence of a cerebral contusion, encephalomalacia, arachnoid cysts, or brain tumors (eg, meningioma) unless approved by the medical monitor.
  3. Current presence of a clinically significant major psychiatric disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV) or any clinically significant symptom that could affect the subject's ability to participate in the study.
  4. Current clinically significant systemic illness that is likely to result in deterioration of the subject's condition or affect the subject's safety during the study.
  5. History of clinically evident stroke or history of clinically significant carotid or vertebrobasilar stenosis or plaque.
  6. History of seizures, excluding febrile seizures in childhood.
  7. Weight greater than 120 kg (264 lbs).
  8. History or evidence of any clinically significant autoimmune disease or disorder of the immune system.
  9. Clinically significant infection within the last 30 days (eg, chronic persistent or acute infection).
  10. Treatment with immunosuppressive medications (eg, systemic corticosteroids) within the last 90 days (topical and nasal corticosteroids and inhaled corticosteroids for asthma are permitted) or chemotherapeutic agents for malignancy within the last three years.
  11. Myocardial infarction within the last two years.
  12. History of cancer within the last five years, with the exception of basal cell carcinoma, and nonmetastatic squamous cell carcinoma of the skin.
  13. Other clinically significant abnormality on screening (ie, Study 201 Visit 22 [Week 78], or Study 102 Visit 11 [Week 16]) physical, neurological, laboratory, or ECG examination (eg, atrial fibrillation) that could compromise the study or be detrimental to the subject.
  14. Hemoglobin less than 11 g/dL at screening (ie, Study 201 Visit 22 [Week 78], or Study 102 Visit 11 [Week16]).
  15. Smoking more than 20 cigarettes per day.
  16. History of alcohol or drug dependence or abuse within the last two years.
  17. Current use of anticonvulsant for seizures, anti-Parkinson's, anticoagulant (excluding the use of aspirin 325 mg/day or less), or narcotic medications.
  18. Any prior experimental treatment with AN1792 or other experimental immunotherapeutic or vaccine for AD (other than bapineuzumab).
  19. Any known hypersensitivity to any of the excipients contained in the study drug formulation.
  20. Women of childbearing potential.
  21. Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, cerebrospinal fluid (CSF) shunts, metal fragments or foreign objects in the eyes, skin, or body that would contraindicate a brain MRI scan (unless otherwise approved by the Sponsor and/or its designees).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00606476

  Hide Study Locations
Locations
United States, Arizona
Janssen AI Investigational Site
Peoria, Arizona, United States, 85381
Janssen AI Investigational Site
Sun City, Arizona, United States, 85351
United States, California
Janssen AI Investigational Site
Encino, California, United States, 91316
Janssen AI Investigational Site
Irvine, California, United States, 92697
Janssen AI Investigational Site
La Jolla, California, United States, 92037
Janssen AI Investigational Site
Los Alamitos, California, United States, 90720
Janssen AI Investigational Site
Sacramento, California, United States, 95817
Janssen AI Investigational Site
San Francisco, California, United States, 94143
United States, Connecticut
Janssen AI Investigational Site
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Janssen AI Investigational Site
Washington, District of Columbia, United States, 20057
United States, Florida
Janssen AI Investigational Site
Delray Beach, Florida, United States, 33445
Janssen AI Investigational Site
Jacksonville, Florida, United States, 32224
United States, Illinois
Janssen AI Investigational Site
Chicago, Illinois, United States, 60612
United States, Indiana
Janssen AI Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Janssen AI Investigational Site
Boston, Massachusetts, United States, 02115
United States, Michigan
Janssen AI Investigational Site
Ann Arbor, Michigan, United States, 48105
United States, Minnesota
Janssen AI Investigational Site
Rochester, Minnesota, United States, 55905
United States, Missouri
Janssen AI Investigational Site
St. Louis, Missouri, United States, 63108
United States, New Jersey
Janssen AI Investigational Site
Eatontown, New Jersey, United States, 07724
United States, New York
Janssen AI Investigational Site
New York City, New York, United States, 10032
Janssen AI Investigational Site
Rochester, New York, United States, 14620
United States, North Carolina
Janssen AI Investigational Site
Durham, North Carolina, United States, 27710
United States, Oregon
Janssen AI Investigational Site
Portland, Oregon, United States, 97239
United States, Pennsylvania
Janssen AI Investigational Site
PIttsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Janssen AI Investigational Site
Providence, Rhode Island, United States, 02906
United States, Texas
Janssen AI Investigational Site
Dallas, Texas, United States, 75390
Janssen AI Investigational Site
Houstan, Texas, United States, 77030
United States, Vermont
Janssen AI Investigational Site
Bennington, Vermont, United States, 05201
United States, Washington
Janssen AI Investigational Site
Seattle, Washington, United States, 98108
Sponsors and Collaborators
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
  More Information

No publications provided

Responsible Party: JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov Identifier: NCT00606476     History of Changes
Other Study ID Numbers: AAB-001-251
Study First Received: January 11, 2008
Last Updated: October 30, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 27, 2014