Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ACC-001 3 μg/ QS-21 50 μg · 1 trial · 1 indication
Fibrillar brain Aβ was measured by retention of florbetapir F18 as measured by positron emission tomography (PET) scans. A positive change indicating an improvement from baseline.
| Arm | Type | Description |
|---|---|---|
| ACC-001 3 μg/ QS-21 50 μg | EXPERIMENTAL | - |
| ACC-001 10 μg/ QS-21 50 μg | EXPERIMENTAL | - |
| Placebo- Phosphate buffered saline (PBS) | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| ACC-001 3 μg/ QS-21 50 μg | BIOLOGICAL | ACC-001 3 μg/ QS-21 50 μg IM on day 1, month 1, month 3, month 6, month 12, and month 18 |
| ACC-001 10 μg/ QS-21 50 μg | BIOLOGICAL | ACC-001 10 μg/ QS-21 50 μg IM on day 1, month 1, month 3, month 6, month 12, and month 18 |
| Placebo- Phosphate buffered saline (PBS) | OTHER | Phosphate buffered saline IM on day 1, month 1, month 3, month 6, month 12, and month 18 |
Inclusion Criteria: * Concern about a change in cognition expressed by the subject or by an informant that knows the subject well * Mini-Mental State Examination (MMSE) score ≥ 25 * Global Clinical Dementia Rating = 0.5. * General cognition and functional performance sufficiently preserved such tha...
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ACC-001 3 μg/ QS-21 50 μg is an investigational monoclonal antibody being developed for the treatment of Alzheimer's Disease. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with early Alzheimer's Disease.
ACC-001 3 μg/ QS-21 50 μg is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with Alzheimer's Disease.
ACC-001 3 μg/ QS-21 50 μg is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. The drug is being studied for the treatment of Alzheimer's Disease.
ACC-001 3 μg/ QS-21 50 μg has been studied in one completed Phase 2 clinical trial, NCT01227564, titled "Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Early Alzheimer's Disease." The trial enrolled 63 participants in the United States and was randomized, double-blind, and placebo-controlled.
ACC-001 3 μg/ QS-21 50 μg is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Alzheimer's Disease. The drug has completed one clinical trial, but it remains under investigation and has not been authorized for commercial use.