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ACC-001

Phase 2

Alzheimer's Disease | Monoclonal antibody | Neurology |Johnson & Johnson|Trials Updated: Jan 5, 2015

ACC-001 development status

Highest phase Phase 2
Registered trials 5 across 1 sponsor since May 2007

ACC-001 target and mechanism

ModalityMonoclonal antibody

Also known as ACC-001 (vanutide cridificar)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindNO_TREATMENT_CONTROLLEDDMC
Total Trials1
Total Enrollment126

FDA Designations

No designations recorded

ACC-001 clinical trials

ACC-001 · 1 trial · 1 indication

Phase 2 1
NCT01284387Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Mild to Moderate Alzheimer's DiseaseAlzheimer's Disease
COMPLETED126 Analytics
PHASE2COMPLETED
Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Mild to Moderate Alzheimer's Disease
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the effect of ACC-001 in combination with an adjuvant immunostimulatory agent (QS-21), administered intramuscularly compared to placebo on cerebral amyloid burden in subjects with mild to moderate Alzheimer's disease.
24 Months

Secondary Endpoints

To evaluate the safety and tolerability of 2 dosage levels of ACC-001 plus QS-21 vs. placebo in subjects with mild to moderate AD.
24 Months
Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in disease biomarkers.
24 Months
Exploratory Outcome Measure: To assess the effects of ACC-001 compared to placebo as measured by change from baseline in measurements of immunogenicity.
24 Months
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
3 μg ACC-001 / QS-21 50 μg IM dose 1EXPERIMENTAL3 μg ACC-001 / QS-21 50 μg IM
10 μg ACC-001 / QS-21 50 μg IM dose 2EXPERIMENTAL10 μg ACC-001 / QS-21 50 μg IM
Placebo - Phosphate buffered saline (PBS) IM doseNO_INTERVENTIONPlacebo - Phosphate buffered saline (PBS) IM

Interventions

NameTypeDescription
ACC-001 (vanutide cridificar)BIOLOGICALComparisons of 2 different doses of ACC-001 or placebo for 24 months
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Eligibility Criteria

Age Range50 Years to 89 Years
SexALL
Healthy VolunteersNo
Study Sites25

Inclusion Criteria: * Diagnosis of probable AD * Age from 50 to 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) * Caregiver able to...

Countries:United States
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Frequently asked questions about ACC-001

What is ACC-001 used for in Alzheimer's Disease?

ACC-001 is an investigational monoclonal antibody developed by Johnson & Johnson for Alzheimer's Disease. It was studied in a Phase 2 clinical trial in subjects with mild to moderate Alzheimer's Disease. It is not approved for any indication and remains in clinical development.

Who makes ACC-001?

ACC-001 is developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company sponsored the Phase 2 study of ACC-001 in Alzheimer's Disease.

What phase is ACC-001 in?

ACC-001 is in Phase 2 development. One Phase 2 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is ACC-001 in?

ACC-001 has been studied in one completed Phase 2 trial, NCT01284387, titled Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Mild to Moderate Alzheimer's Disease. The trial enrolled 126 participants in the United States and was randomized, double-blind, and no-treatment controlled.

Is ACC-001 the same as vanutide cridificar?

Yes, ACC-001 is also known as vanutide cridificar. Both names refer to the same investigational monoclonal antibody developed by Johnson & Johnson for Alzheimer's Disease.