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bapineuzumab

Phase 3

Alzheimer's Disease | Small molecule | Neurology |Johnson & Johnson|Last Updated: Nov 25, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials3
Total Enrollment2,686

FDA Designations

No designations recorded

Clinical trial landscape

bapineuzumab · 3 trials · 1 indication

Phase 3 2Phase 2 1
NCT00574132Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Non-Carrier)Alzheimer's Disease
COMPLETED1,331 Analytics
NCT00575055Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Carrier)Alzheimer's Disease
COMPLETED1,121 Analytics
PHASE3COMPLETED
Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Non-Carrier)
Alzheimer's DiseaseUnlock trial analytics
PHASE3COMPLETED
Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Carrier)
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Cognitive and Functional
18 months
safety assessments
18 months

Secondary Endpoints

Cognitive and Global
18 months
Imaging and biochemical biomarkers of disease status
18 months
blood levels of administered study drug
18 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Bapineuzumab 0.5 mg/kgEXPERIMENTALinfusion every 13 weeks for a total of 6 infusions
Placebo ControlPLACEBO_COMPARATORinfusion every 13 weeks for a total of 6 infusions.
Bapineuzumab 1.0 m/kgEXPERIMENTALinfusion every 13 weeks for a total of 6 infusions.
Placebo DosePLACEBO_COMPARATORinfusion every 13 weeks for a total of 6 infusions.
0.15 mg/kg active bapineuzumabEXPERIMENTAL -
0.15 mg/kg placeboPLACEBO_COMPARATOR -
0.5 mg/kg active bapineuzumabEXPERIMENTAL -
0.5 mg/kg placeboPLACEBO_COMPARATOR -
1.0 mg/kg active bapineuzumabEXPERIMENTAL -
1.0 mg/kg placeboPLACEBO_COMPARATOR -
2.0 mg/kg active bapineuzumabEXPERIMENTAL -
2.0 mg/kg placeboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Bapineuzumab 0.5 mg/kgDRUGinfusion every 13 weeks for a total of 6 infusions
Placebo ControlDRUGgiven by infusion every 13 weeks for a total of 6 infusions.
Bapineuzumab 1.0 m/kgDRUGinfusion every 13 weeks for a total of 6 infusions
bapineuzumabDRUGIV, Q13w
placeboOTHERIV Q13w
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Eligibility Criteria

Age Range50 Years to 88 Years
SexALL
Healthy VolunteersNo
Study Sites251

Inclusion Criteria: * Diagnosis of probable AD * Age from 50 to less than 89 * Mini-Mental Status Exam score of 16-26 inclusive * Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD * Stable doses of medications (cholinesterase inhibitors and memantine allowed) * Caregiv...

Countries:United StatesAustriaCanadaGermany
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Frequently asked questions about bapineuzumab

What is bapineuzumab used for?

Bapineuzumab is an investigational drug being studied for the treatment of Alzheimer's disease. It has been evaluated in patients with mild to moderate Alzheimer's disease in clinical trials. As of the available data, it is not approved and remains in clinical development.

Who makes bapineuzumab?

Bapineuzumab is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug has been studied in clinical trials for Alzheimer's disease.

What phase is bapineuzumab in?

Bapineuzumab has completed Phase 3 clinical trials for Alzheimer's disease. It is an investigational drug and has not been approved by regulatory authorities. All three clinical trials listed for bapineuzumab are completed, with no active trials ongoing.

What clinical trials is bapineuzumab in?

Bapineuzumab has been studied in three completed clinical trials. NCT00112073 was a Phase 2 trial with 234 participants. NCT00574132 and NCT00575055 were Phase 3 trials with 1331 and 1121 participants, respectively, all in patients with mild to moderate Alzheimer's disease.

Is bapineuzumab the same as AAB-001?

Yes, bapineuzumab is also known as AAB-001. The Phase 2 clinical trial NCT00112073 is titled 'AAB-001 in Patients With Mild to Moderate Alzheimer's Disease,' confirming that AAB-001 is an alternative name for bapineuzumab.