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Experimental Bapineuzumab

Phase 2

Alzheimer's Disease | Small molecule | Neurology |Johnson & Johnson|Last Updated: May 9, 2014

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

Clinical trial landscape

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 used for?

Experimental Bapineuzumab is an investigational small molecule being studied for the treatment of Alzheimer's Disease. It is intended for patients with mild to moderate Alzheimer's Disease, as evaluated in a clinical trial. The drug is not approved and remains in clinical development.

Who makes Experimental Bapineuzumab?

Experimental Bapineuzumab is being developed by Johnson & Johnson, which trades under the ticker JNJ. The company is conducting clinical research on this investigational drug for Alzheimer's Disease.

What phase is Experimental Bapineuzumab in?

Experimental Bapineuzumab is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy in patients with Alzheimer's Disease.

What clinical trials is Experimental Bapineuzumab in?

Experimental Bapineuzumab has one completed clinical trial, NCT01254773, titled "Amyloid Imaging And Safety Study Of Subcutaneous Bapineuzumab In Subjects With Mild to Moderate Alzheimer's Disease." This Phase 2 study enrolled 146 participants in the United States and was placebo-controlled, randomized, and double-blind.

Is Experimental Bapineuzumab the same as bapineuzumab?

Experimental Bapineuzumab is the same drug as bapineuzumab, with "Experimental" indicating its investigational status. It is being studied for Alzheimer's Disease and has completed a Phase 2 trial under the identifier NCT01254773.