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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00568776 | ELND005 in Patients With Mild to Moderate Alzheimer's Disease | PHASE2 | COMPLETED | 353 | — | — | Dec 1, 2007 | May 1, 2010 | Nov 1, 2019 | 62 | United States, Canada |
The NTB assessment is comprised of 9 instruments that measure cognition and executive function. Three of these tests measure immediate memory, next three measure delayed memory, and remaining three assess executive function. The total score is a weighted mean of the nine tests, referred to as the Z-score. Typically, scores range from -3 and 3, with lower scores suggesting greater cognitive impairment.
The NTB assessment is comprised of 9 instruments that measure cognition and executive function. Three of these tests measure immediate memory, next three measure delayed memory, and remaining three assess executive function. The total score is a weighted mean of the nine tests, referred to as the Z-score. Typically, scores range from -3 and 3, with lower scores suggesting greater cognitive impairment.
The ADCS-ADL is a 23-item scale that measures a subject's functional abilities as assessed by the subject's caregiver. This scale ranges from 0 to 78, with lower scores suggesting greater functional impairment.
The ADCS-ADL is a 23-item scale that measures a subject's functional abilities as assessed by the subject's caregiver. This scale ranges from 0 to 78, with lower scores suggesting greater functional impairment.
| Arm | Type | Description |
|---|---|---|
| 1 | PLACEBO_COMPARATOR | - |
| 2 | ACTIVE_COMPARATOR | - |
| 3 | ACTIVE_COMPARATOR | - |
| 4 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Placebo Control | DRUG | ELND005 matched placebo capsules for oral administration, bid for 78 weeks |
| ELND005 | DRUG | ELND005 capsules for oral administration at a dose of 2000 mg bid for 78 weeks |
Inclusion Criteria: * Diagnosis of probable AD * Age 50 to 85 years, inclusive * Mini-Mental Status Exam (MMSE) score of 16-26, inclusive * Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD * Fluency in English, French, or Spanish * Stable doses of medications (choline...