Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01227564 | Amyloid Imaging And Safety Study Of ACC-001 In Subjects With Early Alzheimer's Disease | PHASE2 | COMPLETED | 63 | — | — | Feb 1, 2011 | Feb 1, 2014 | Feb 25, 2016 | 40 | United States |
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...