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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00959192 | Safety, Tolerability, And Immunogenicity Study Of ACC-001 In Japanese Subjects With Mild To Moderate Alzheimer's Disease | PHASE2 | COMPLETED | 32 | — | — | Aug 1, 2009 | Jan 1, 2013 | Jan 1, 2016 | 9 | Japan |
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