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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00464334 | A Study of V950 in People With Alzheimer Disease (V950-001 AM7) | PHASE1 | COMPLETED | 86 | — | — | Mar 1, 2007 | Jan 1, 2012 | Sep 25, 2015 | - | — |
An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
This is a measure of the number of participants who discontinued study drug because of an adverse event. An adverse event is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the product.
The level of Aβ Peptide 1-40 specific antibodies was measured as the geometric mean titer (GMT) one month after the third dose (Month 7) of vaccine using an enzyme-linked immunosorbent assay (ELISA).
The Aβ Peptide 1-40 specific immunogenicity of 3-dose regimen of V950 was measured one month after the third dose (Month 7) of vaccine by the GMT fold change of Aβ 1-40 specific antibodies compared to Baseline (Month 0) using ELISA.
| Arm | Type | Description |
|---|---|---|
| Placebo to V950/IMX 0 mcg | EXPERIMENTAL | Participants receive Placebo to V950/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6. |
| Placebo to V950/IMX 16 mcg | EXPERIMENTAL | Participants receive Placebo to V950/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6. |
| V950 0.5 mcg/IMX 0 mcg | EXPERIMENTAL | Participants receive V950 0.5 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6. |
| V950 0.5 mcg/IMX 16 mcg | EXPERIMENTAL | Participants receive V950 0.5 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6. |
| V950 0.5 mcg/IMX 47 mcg | EXPERIMENTAL | Participants receive V950 0.5 mcg/IMX 47 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6. |
| V950 0.5 mcg/IMX 94 mcg | EXPERIMENTAL | Participants receive V950 0.5 mcg/IMX 94 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6. |
| V950 5 mcg/IMX 0 mcg | EXPERIMENTAL | Participants receive V950 5 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6. |
| V950 5 mcg/IMX 16 mcg | EXPERIMENTAL | Participants receive V950 5 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6. |
| V950 5 mcg/IMX 47 mcg | EXPERIMENTAL | Participants receive V950 5 mcg/IMX 47 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6. |
| V950 50 mcg/IMX 0 mcg | EXPERIMENTAL | Participants receive V950 50 mcg/IMX 0 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6. |
| V950 50 mcg/IMX 16 mcg | EXPERIMENTAL | Participants receive V950 50 mcg/IMX 16 mcg, 0.5 mL intramuscular injection at Months 0, 2 and 6. |
| Name | Type | Description |
|---|---|---|
| V950 | BIOLOGICAL | V950 will be given in doses of 0.5, 5 or 50 mcg depending on arm assignment. |
| ISCOMATRIX™ | BIOLOGICAL | ISCOMATRIX will be given in doses of 0, 16, 47 or 94 mcg depending on arm assignment. |
| Placebo to V950 | BIOLOGICAL | - |
Inclusion Criteria: * Patient has mild to moderate Alzheimer Disease * Women cannot be able to get pregnant * Patient has a reliable caregiver, who will attend all visits and answer questions about the patient Exclusion Criteria: * Patient lives in a nursing home or facility * Patient has another...