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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01614886 | Randomized, Double-blind Study to Evaluate the Tolerability of 2 Different Titration Methods of Rivastigmine Patch in AD Patients (MMSE 10-20) | PHASE3 | COMPLETED | 216 | — | — | Jul 1, 2012 | May 1, 2014 | Aug 1, 2016 | 50 | Japan |
The primary variable of this study is the percentage of patients having an AE leading to study drug discontinuation during the 24-week double-blind treatment period.
| Arm | Type | Description |
|---|---|---|
| 1 step | EXPERIMENTAL | - |
| 3 step | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Active Comparator | DRUG | 1-step titration group begin treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day. |
| ENA713 | DRUG | -3-step titration group will begin treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day. |
Inclusion Criteria: * A diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria * A clinical diagnosis of probable AD according to NINCDS/ADRDA criteria * An MMSE score of ≥ 10 and ≤ 20 at baseline Exclusion Criteria: * Any medical or neurological conditions other than AD t...