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Experimental Bapineuzumab

Phase 2

Alzheimer's Disease | Monoclonal antibody | Neurology |Johnson & Johnson|Trials Updated: May 9, 2014

Experimental Bapineuzumab development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Dec 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment146

FDA Designations

No designations recorded

Experimental Bapineuzumab clinical trials

Experimental Bapineuzumab · 1 trial · 1 indication

Phase 2 1
NCT01254773Amyloid Imaging And Safety Study Of Subcutaneous Bapineuzumab In Subjects With Mild to Moderate Alzheimer's DiseaseAlzheimer's Disease
COMPLETED146 Analytics
PHASE2COMPLETED
Amyloid Imaging And Safety Study Of Subcutaneous Bapineuzumab In Subjects With Mild to Moderate Alzheimer's Disease
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the effect of bapineuzumab administered subcutaneously (SC) at monthly intervals compared to placebo on cerebral amyloid burden in subjects with mild to moderate AD.
24 months

Secondary Endpoints

To assess the safety of bapineuzumab administered SC at monthly intervals compared to placebo in subjects with mild to moderate AD
24 months
To assess the effect of bapineuzumab administered SC at monthly intervals compared to placebo on cognitive and functional endpoints.
24 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Bapineuzumab SC Dose 1; 2 mgEXPERIMENTAL -
Bapineuzumab SC Dose 2; 7 mgEXPERIMENTAL -
Bapineuzumab SC Dose 3; 20 mgEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Experimental BapineuzumabDRUGBapineuzumab 2 mg, Bapineuzumab 7 mg, Bapineuzumab 20 mg, Placebo
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Eligibility Criteria

Age Range50 Years to 89 Years
SexALL
Healthy VolunteersNo
Study Sites28

Inclusion Criteria: * Diagnosis of probable AD * Age from 50 to less than 89 * Mini-Mental Status Exam score of 18-26 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 States
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Frequently asked questions about Experimental Bapineuzumab

What is Experimental Bapineuzumab?

Experimental Bapineuzumab is an investigational monoclonal antibody developed by Johnson & Johnson for Alzheimer's disease. It was studied as a subcutaneous treatment in a Phase 2 clinical trial. It is not an approved therapy and remains in clinical development.

What is Experimental Bapineuzumab used for in Alzheimer's disease?

Experimental Bapineuzumab was studied for the treatment of mild to moderate Alzheimer's disease. The Phase 2 trial enrolled 146 participants with this condition. It is an investigational agent and has not been approved for any indication.

Who makes Experimental Bapineuzumab?

Experimental Bapineuzumab is developed by Johnson & Johnson, which trades under the ticker symbol JNJ. The company sponsored the Phase 2 clinical trial evaluating the drug in Alzheimer's disease.

What phase is Experimental Bapineuzumab in?

Experimental Bapineuzumab is in Phase 2 development. One Phase 2 trial has been completed, and no active trials are ongoing. The drug is investigational and has not received FDA approval.

What clinical trials is Experimental Bapineuzumab in?

Experimental Bapineuzumab was evaluated in a single Phase 2 trial, NCT01254773, titled "Amyloid Imaging And Safety Study Of Subcutaneous Bapineuzumab In Subjects With Mild to Moderate Alzheimer's Disease." The trial was completed, enrolled 146 participants, and was conducted in the United States.