Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ACC-001+ QS-21 · 4 trials · 1 indication
An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor's clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
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 investigator.
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(3µg) + QS21 | EXPERIMENTAL | ACC-001(3µg) + QS21 |
| ACC-001(10µg) + QS21 | EXPERIMENTAL | ACC-001(10µg) + QS21 |
| ACC-001(30µg) + QS21 | EXPERIMENTAL | ACC-001(30µg) + QS21 |
| ACC-001+QS-21 | EXPERIMENTAL | Active vaccine + adjuvant, IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12 |
| ACC-001 | EXPERIMENTAL | Active vaccine, IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12 |
| QS-21 | PLACEBO_COMPARATOR | Adjuvant, IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12 |
| PBS | PLACEBO_COMPARATOR | Placebo, IM injection, Day 1, month 3, 6, 9, 12 |
| 1 | EXPERIMENTAL | ACC-001 |
| 2 | OTHER | QS-21 |
| 3 | OTHER | Diluent: Phosphate Buffered Saline |
| 4 | EXPERIMENTAL | ACC-001 |
| Name | Type | Description |
|---|---|---|
| ACC-001(3µg) + QS21 | BIOLOGICAL | Vanutide Cridificar (ACC-001) 3µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18 |
| ACC-001(10µg) + QS21 | BIOLOGICAL | Vanutide Cridificar (ACC-001) 10µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18 |
| ACC-001(30µg) + QS21 | BIOLOGICAL | Vanutide Cridificar (ACC-001) 30 µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18 |
| ACC-001 | BIOLOGICAL | IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12 |
| QS-21 | OTHER | IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12 |
| PBS | OTHER | IM injection, Day 1, month 3, 6, 9, 12 |
| ACC-001 + QS-21 | BIOLOGICAL | IM injection, ACC-001 (3ug, or 10ug, or 30ug) + QS-21 50ug at Day 1 and weeks 4, 12, 26, and 52 |
| Diluent: Phosphate Buffered Saline | OTHER | IM injection, PBS Diluent at Day 1 and weeks 4, 12, 26, and 52 |
| Placebo: Phosphate buffered saline | DRUG | Phosphate buffered Saline (pH : 7.4), IM on day 1, month 1, month 3, month 6 and month 12 |
Inclusion Criteria: * Subjects randomized under previous 3134K1-200 study (NCT00479557) and met all inclusion/and none of the exclusion criteria * Screening brain MRI scan is consistent with the diagnosis of AD ' Mini-Mental State Examination (MMSE) score ≥10 Exclusion Criteria: * Significant Neu...
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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.