Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ACC-001 · 1 trial · 1 indication
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 MRI data that are either consistent or not consistent with AD, as determined by radiologists.
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.
| Arm | Type | Description |
|---|---|---|
| ACC-001 + QS-21 | EXPERIMENTAL | Active vaccine + adjuvant, IM injection, dose of 3, 10 and 30 micrograms, at Day 1, month 1, 3, 6 and 12 |
| QS-21 | PLACEBO_COMPARATOR | Adjuvant, IM injection, dose 50 micrograms, at Day 1, month 1, 3, 6 and 12 |
| Name | Type | Description |
|---|---|---|
| ACC-001 | BIOLOGICAL | IM injection, dose of 3, 10 and 30 micrograms, at Day 1, month 1, 3, 6 and 12 |
| QS-21 | OTHER | IM injection, dose of 50 micrograms, at Day 1, month 1, 3, 6 and 12 |
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
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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.
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.
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.
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.
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.