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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00506415 | Comparative Efficacy, Safety, and Tolerability of Rivastigmine 10 and 15 cm^2 Patch in Patients With Alzheimer's Disease (AD) Showing Cognitive Decline | PHASE3 | COMPLETED | 1,584 | — | — | Jun 1, 2007 | May 1, 2011 | Sep 19, 2012 | 145 | United States, Canada +5 |
The Alzheimer's Disease Assessment Scale-Cognitive (ADAS-cog) subscale comprises 11 items summed to a total score ranging from 0 to 70, with lower scores indicating less severe impairment. A negative change indicates an improvement from baseline.
The Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living (ADCS-IADL) is a 16 item subscale of the caregiver-based ADCS-IADL scale, developed for the use in dementia studies. The ADCS-IADL total score ranges from 0 to 56, with higher scores indicating less severe impairment. A positive change indicates an improvement from baseline.
| Arm | Type | Description |
|---|---|---|
| Open label: Rivastigmine (5 cm^2 / 10 cm^2) | EXPERIMENTAL | Rivastigmine 5 cm\^2 transdermal patch once a day during the first 4 weeks of open label treatment followed by rivastigmine 10 cm\^2 transdermal patch once a day from week 4 to week 24, 36 or 48. |
| Double blind: Rivastigmine (10 cm^2) | EXPERIMENTAL | Rivastigmine transdermal patch 10 cm\^2 and placebo to rivastigmine 15 cm\^2 once daily for 48 weeks during the double blind period. |
| Double blind: Rivastigmine (15 cm^2) | EXPERIMENTAL | Rivastigmine transdermal patch 15 cm\^2 and placebo to rivastigmine 10 cm\^2 once daily for 48 weeks during double blind period. |
| Extended open label Rivastigmine (10 cm^2) | EXPERIMENTAL | Rivastigmine 10 cm\^2 transdermal patch once a day during 48 weeks open label treatment running in parallel to the double blind period. |
| Name | Type | Description |
|---|---|---|
| Rivastigmine 5 cm^2 | DRUG | 5 cm\^2 transdermal patch |
| Rivastigmine 10 cm^2 | DRUG | 10 cm\^2 transdermal patch. |
| Rivastigmine 15 cm^2 | DRUG | 15 cm\^2 transdermal patch. |
| Placebo to 15 cm^2 patch | DRUG | Placebo of rivastigmine transdermal patch 15 cm\^2. |
| Placebo to 10 cm^2 patch | DRUG | Placebo of rivastigmine transdermal patch 10 cm\^2. |
Inclusion Criteria: * Male or female patients between 50 and 85 years of age with a diagnosis of probable Alzheimers Disease, * Baseline Mini-Mental State Examination (MMSE) score 10-24 inclusive, * A primary caregiver willing to accept responsibility for supervising treatment, assessing the patien...