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ACC-001

Phase 2

Alzheimer's Disease | Monoclonal antibody | Neurology |Pfizer, Inc.|Last Updated: Jan 1, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

ACC-001 · 1 trial · 1 indication

Phase 2 1
NCT00959192Safety, Tolerability, And Immunogenicity Study Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's DiseaseAlzheimer's Disease
COMPLETED32 Analytics
PHASE2COMPLETED
Safety, Tolerability, And Immunogenicity Study Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Treatment-emergent Adverse Events (AEs) by Severity
Baseline up to 24 months

Number of participants who experienced mild, moderate, or severe AEs (mild = does not interfere with subject's usual function; moderate = interferes to some extent with subject's usual function; severe = interferes significantly with subject's usual function)

Number of Participants With Brain Abnormalities in Magnetic Resonance Imaging (MRI) Data
Baseline up to 24 months

Number of participants with brain abnormalities in MRI data that are either consistent or not consistent with AD, as determined by radiologists.

Number of Participants With Abnormalities in Neurological Examination
Baseline up to 24 months

Number of participants with abnormalities in neurological examinations as determined by the investigators. Neurological examinations included Mental Status, Speech, Cranial Nerves (including pupil equality and reactivity), Visual field, Sensory, Motor, Coordination, Gait, Primitive reflexes, Tendon reflexes and Romberg.

Secondary Endpoints

Anti-a-beta IgG Titer at Specified Visits
Baseline up to 24 months
Anti-a-beta IgM Titer at Specified Visits
Baseline up to 24 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ACC-001 + QS-21EXPERIMENTALActive vaccine + adjuvant, IM injection, dose of 3, 10 and 30 micrograms, at Day 1, month 1, 3, 6 and 12
QS-21PLACEBO_COMPARATORAdjuvant, IM injection, dose 50 micrograms, at Day 1, month 1, 3, 6 and 12

Interventions

NameTypeDescription
ACC-001BIOLOGICALIM injection, dose of 3, 10 and 30 micrograms, at Day 1, month 1, 3, 6 and 12
QS-21OTHERIM injection, dose of 50 micrograms, at Day 1, month 1, 3, 6 and 12
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Eligibility Criteria

Age Range50 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Diagnosis of mild to moderate Alzheimer's Disease * Mini-Mental State Examination (MMSE) 16-26 Exclusion Criteria: * Significant Neurological Disease other than Alzheimer's disease * Major psychiatric disorder * Clinically significant systemic illness

Countries:Japan
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Frequently asked questions about ACC-001

What is ACC-001 used for?

ACC-001 is an investigational monoclonal antibody being studied for the treatment of Alzheimer's disease, specifically in patients with mild to moderate forms of the condition. It has been evaluated in clinical trials across multiple countries, including the United States, Japan, France, Germany, and Spain.

Who makes ACC-001?

ACC-001 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The company has sponsored multiple clinical trials to evaluate the safety, tolerability, and immunogenicity of this investigational therapy in patients with Alzheimer's disease.

What phase is ACC-001 in?

ACC-001 is in Phase 2 clinical development. All four completed trials for this drug were Phase 2 studies, and none are currently active. The investigational therapy has not been approved by regulatory authorities and remains in clinical development for Alzheimer's disease.

What clinical trials is ACC-001 in?

ACC-001 has been studied in four completed Phase 2 clinical trials: NCT00479557, NCT00498602, NCT00752232, and NCT00955409. These trials evaluated the drug in patients with mild to moderate Alzheimer's disease across the United States, Japan, France, Germany, and Spain, with a total enrollment of 446 participants.

Is ACC-001 the same as a vaccine for Alzheimer's?

ACC-001 is an investigational monoclonal antibody designed to target Alzheimer's disease. While it is not described as a vaccine in the available data, its clinical trials focused on assessing immunogenicity, which relates to the immune response. The drug is being developed by Pfizer for mild to moderate Alzheimer's disease.