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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00810147 | A Phase II, Multicenter, Double Blind, Placebo-Controlled Safety, Tolerability Study of BMS-708163 in Patients With Mild to Moderate Alzheimer's Disease | PHASE2 | COMPLETED | 209 | — | — | Feb 1, 2009 | Jun 1, 2010 | Oct 12, 2015 | 41 | United States, Denmark +2 |
| NCT01079819 | Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-708163 | PHASE1 | COMPLETED | 32 | — | — | Apr 1, 2010 | Dec 1, 2010 | Feb 7, 2011 | 3 | United States |
| NCT00901498 | Relative Bioavailability Study of Four Experimental Formulations for Alzheimer's Disease | PHASE1 | COMPLETED | 36 | — | — | May 1, 2009 | Jul 1, 2009 | Jan 7, 2011 | 1 | United States |
| NCT01454115 | Study to Evaluate the Safety, Pharmacokinetics and Tolerability of BMS-708163 | PHASE1 | COMPLETED | 116 | — | — | Jun 1, 2007 | Mar 1, 2009 | Nov 21, 2011 | - | — |
Based on adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests
| Arm | Type | Description |
|---|---|---|
| A1 | ACTIVE_COMPARATOR | - |
| A2 | ACTIVE_COMPARATOR | - |
| A3 | ACTIVE_COMPARATOR | - |
| A4 | ACTIVE_COMPARATOR | - |
| A5 | PLACEBO_COMPARATOR | - |
| A1 (BMS-708163) | ACTIVE_COMPARATOR | - |
| A2 (Placebo) | PLACEBO_COMPARATOR | - |
| B1 (BMS-708163) | ACTIVE_COMPARATOR | - |
| B2 (Placebo) | PLACEBO_COMPARATOR | - |
| Treatment A (Reference) | EXPERIMENTAL | - |
| Treatment B | ACTIVE_COMPARATOR | - |
| Treatment C | ACTIVE_COMPARATOR | - |
| Treatment D | ACTIVE_COMPARATOR | - |
| Treatment E | ACTIVE_COMPARATOR | - |
| Panel 1: BMS-708163 or Placebo | EXPERIMENTAL | Healthy male subjects (age: 18 to 45 years) |
| Panel 2: BMS-708163 or Placebo | EXPERIMENTAL | Healthy male subjects (age: 18 to 45 years) |
| Panel 3: BMS-708163 or Placebo | EXPERIMENTAL | Healthy male subjects (age: 18 to 45 years) |
| Panel 4: BMS-708163 or Placebo | EXPERIMENTAL | Healthy male subjects (age: 18 to 45 years) |
| Panel 5: BMS-708163 or Placebo | EXPERIMENTAL | Healthy male subjects (age: 18 to 45 years). In Period 2: Subjects will receive BMS-708163 or placebo as a capsule formulation. In Period 3: Subjects will receive BMS-708163 or placebo as a capsule formulation within 5 minutes of consuming a standard high-fat breakfast on Day 1 |
| Panel 6: BMS-708163 or Placebo | EXPERIMENTAL | Healthy male subjects (age: 18 to 45 years) |
| Panel 7: BMS-708163 or Placebo | EXPERIMENTAL | Healthy male subjects (age: 18 to 45 years) |
| Panel 8: BMS-708163 or Placebo | EXPERIMENTAL | Healthy male subjects (age: 18 to 45 years) |
| Panel 9: BMS-708163 or Placebo | EXPERIMENTAL | Healthy, elderly male subjects (age: 60 years and greater) |
| Panel 10: BMS-708163 or Placebo | EXPERIMENTAL | Healthy, elderly female subjects (age: 60 years and greater) |
| Panel 11: BMS-708163 or Placebo | EXPERIMENTAL | Healthy male subjects (age: between 46 to 59 years) |
| Panel 12: BMS-708163 or Placebo | EXPERIMENTAL | Healthy male and/or female subjects or subjects with MCI (age: between 60-74 years) |
| Panel 13: BMS-708163 or Placebo | EXPERIMENTAL | Healthy male and/or female subjects or with AD or MCI (age: 75 years or greater) |
| Panel 15: BMS-708163 or Placebo | EXPERIMENTAL | Healthy young male subjects |
| Name | Type | Description |
|---|---|---|
| BMS-708163 | DRUG | Capsules, Oral, 25 mg, once daily, 24 weeks |
| Placebo | DRUG | Capsules, Oral, 0 mg, once daily, 24 weeks |
| BMS-708163 (Gamma-Secretase Inhibitor) | DRUG | Oral Solution, Oral, 0.3 mg, Once daily, once |
| Placebo matching BMS-708163 | DRUG | Oral Solution, Oral, 0 mg, Once daily, once |
Inclusion Criteria: * Clinical diagnosis of Mild to Moderate Alzheimer's disease (MMSE 16-26) * 6 Month cognitive decline * Stable marketed AD therapy x2 months or additional marketed AD therapy during study * Score of \<=4 on the Modified Hachinski Ischemia Scale * CT results consistent with Alzhe...