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Alzheimer's DiseasePhase 2NCT00606476

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

A Phase 2 study testing Bapineuzumab (AAB-001) in people with Alzheimer's Disease, run by JANSSEN Alzheimer Immunotherapy Research & Development, LLC at 29 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Alzheimer's Disease
What is being tested?
Bapineuzumab (AAB-001)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
194 participants
Where
29 sitesUnited States
Study dates
Dec 2006to Sep 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • A subject must meet ALL of the following criteria to be considered for enrollment into this study:
  • Signed and dated written informed consent obtained from the subject and/or the subject's caregiver in accordance with the local regulations.
  • Subjects must have completed Study 201 Visit 22 (Week 78), or Study 102 Visit 11 (Week 16).
  • 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.
  • 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.
  • In the opinion of the investigator, the subject and the caregiver will be compliant.

Who cannot join

  • ANY one of the following will exclude a subject from being enrolled into the study:
  • Significant neurological disease other than AD that may affect cognition.
  • 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.
  • 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.
  • 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.
  • History of clinically evident stroke or history of clinically significant carotid or vertebrobasilar stenosis or plaque.
Show all 22Show fewer
  • History of seizures, excluding febrile seizures in childhood.
  • Weight greater than 120 kg (264 lbs).
  • History or evidence of any clinically significant autoimmune disease or disorder of the immune system.
  • Clinically significant infection within the last 30 days (eg, chronic persistent or acute infection).
  • 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.
  • Myocardial infarction within the last two years.
  • History of cancer within the last five years, with the exception of basal cell carcinoma, and nonmetastatic squamous cell carcinoma of the skin.
  • 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.
  • Hemoglobin less than 11 g/dL at screening (ie, Study 201 Visit 22 [Week 78], or Study 102 Visit 11 [Week16]).
  • Smoking more than 20 cigarettes per day.
  • History of alcohol or drug dependence or abuse within the last two years.
  • Current use of anticonvulsant for seizures, anti-Parkinson's, anticoagulant (excluding the use of aspirin 325 mg/day or less), or narcotic medications.
  • Any prior experimental treatment with AN1792 or other experimental immunotherapeutic or vaccine for AD (other than bapineuzumab).
  • Any known hypersensitivity to any of the excipients contained in the study drug formulation.
  • Women of childbearing potential.
  • 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).

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

United States29 sites

  • Janssen AI Investigational Site

    Ann Arbor, Michigan, 48105

  • Janssen AI Investigational Site

    Bennington, Vermont, 05201

  • Janssen AI Investigational Site

    Boston, Massachusetts, 02115

  • Janssen AI Investigational Site

    Chicago, Illinois, 60612

  • Janssen AI Investigational Site

    Dallas, Texas, 75390

  • Janssen AI Investigational Site

    Delray Beach, Florida, 33445

  • Janssen AI Investigational Site

    Durham, North Carolina, 27710

  • Janssen AI Investigational Site

    Eatontown, New Jersey, 07724

  • Janssen AI Investigational Site

    Encino, California, 91316

  • Janssen AI Investigational Site

    Houstan, Texas, 77030

  • Janssen AI Investigational Site

    Indianapolis, Indiana, 46202

  • Janssen AI Investigational Site

    Irvine, California, 92697

  • Janssen AI Investigational Site

    Jacksonville, Florida, 32224

  • Janssen AI Investigational Site

    La Jolla, California, 92037

  • Janssen AI Investigational Site

    Los Alamitos, California, 90720

  • Janssen AI Investigational Site

    New Haven, Connecticut, 06510

  • Janssen AI Investigational Site

    New York, New York, 10032

  • Janssen AI Investigational Site

    Peoria, Arizona, 85381

  • Janssen AI Investigational Site

    Pittsburgh, Pennsylvania, 15213

  • Janssen AI Investigational Site

    Portland, Oregon, 97239

  • Janssen AI Investigational Site

    Providence, Rhode Island, 02906

  • Janssen AI Investigational Site

    Rochester, Minnesota, 55905

  • Janssen AI Investigational Site

    Rochester, New York, 14620

  • Janssen AI Investigational Site

    Sacramento, California, 95817

  • Janssen AI Investigational Site

    San Francisco, California, 94143

  • Janssen AI Investigational Site

    Seattle, Washington, 98108

  • Janssen AI Investigational Site

    St Louis, Missouri, 63108

  • Janssen AI Investigational Site

    Sun City, Arizona, 85351

  • Janssen AI Investigational Site

    Washington D.C., District of Columbia, 20057

Other trials in United States

About this study

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

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.

Being tested
Bapineuzumab (AAB-001)
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bapineuzumab (AAB-001)Drug

    Also called AAB-001

    IV q13w

Study groups in NCT00606476
Study groupRoleWhat they receive
1Active comparator0.15 mg/kg active bapineuzumab
Receives: Drug: Bapineuzumab (AAB-001)
2Active comparator0.5 mg/kg active bapineuzumab
Receives: Drug: Bapineuzumab (AAB-001)
3Active comparator1.0 mg/kg active bapineuzmab
Receives: Drug: Bapineuzumab (AAB-001)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To assess the safety and tolerability of long-term treatment of bapineuzumab in subjects with AD.

    • 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).

    Measured: 3-84 months

Secondary outcomes (1)

  1. To evaluate the efficacy of long-term treatment of bapineuzumab in subjects with AD.

    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

    Measured: 3-84 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2008 (estimated)
  2. Study startDec 2006
  3. Primary completionSep 2012
  4. Study completionSep 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
194 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00606476
Sponsor's protocol ID
AAB-001-251
Status last verified
Aug 2012
First submitted
11 Jan 2008
Last updated
25 Nov 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Salloway S, Marshall GA, Lu M, Brashear HR. Long-Term Safety and Efficacy of Bapineuzumab in Patients with Mild-to-Moderate Alzheimer's Disease: A Phase 2, Open-Label Extension Study. Curr Alzheimer Res. 2018;15(13):1231-1243. doi: 10.2174/1567205015666180821114813.

    PubMed 30129411

  • Arrighi HM, Barakos J, Barkhof F, Tampieri D, Jack C Jr, Melancon D, Morris K, Ketter N, Liu E, Brashear HR. Amyloid-related imaging abnormalities-haemosiderin (ARIA-H) in patients with Alzheimer's disease treated with bapineuzumab: a historical, prospective secondary analysis. J Neurol Neurosurg Psychiatry. 2016 Jan;87(1):106-12. doi: 10.1136/jnnp-2014-309493. Epub 2015 Feb 10.

    PubMed 25669746

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bapineuzumab (AAB-001) in people with Alzheimer's Disease, run by JANSSEN Alzheimer Immunotherapy Research & Development, LLC at 29 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess the safety and tolerability of long-term treatment of bapineuzumab in subjects with AD. (time frame: 3-84 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00606476, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2013.

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