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ACC-001

Phase 2

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

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

Clinical trial landscape

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 being developed for the treatment of Alzheimer's Disease. It is intended for patients with mild to moderate Alzheimer's Disease, as studied in a Phase 2 clinical trial. The drug is not yet approved and remains in clinical development.

What does ACC-001 target?

ACC-001 is a monoclonal antibody, but its specific molecular target has not been disclosed in the available information. The drug is being studied for its effects on Alzheimer's Disease, and the clinical trial included amyloid imaging to assess its impact on amyloid plaques in the brain.

Who makes ACC-001?

ACC-001 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug for Alzheimer's Disease.

What phase is ACC-001 in?

ACC-001 is in Phase 2 clinical development. A Phase 2 trial has been completed, and the drug is not yet approved by regulatory authorities. It remains an investigational agent, and further studies may be needed to establish its safety and effectiveness.

What clinical trials is ACC-001 in?

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

Is ACC-001 the same as any other drug?

ACC-001 is not known to have any alternative names. It is a distinct investigational monoclonal antibody being developed by Johnson & Johnson for Alzheimer's Disease. No other names for this drug have been reported in the available information.