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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01487317 | Rivastigmine in the Management of Delirium | PHASE3 | COMPLETED | 23 | — | — | Jun 1, 2011 | Feb 1, 2016 | Jul 20, 2016 | 1 | France |
| Arm | Type | Description |
|---|---|---|
| Rivastigmine transdermal patch | EXPERIMENTAL | - |
| placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Rivastigmine transdermal patch | DRUG | One transdermal patch of Rivastigmine (equivalent to 4.6 mg/24h per os) per day from randomization to day 14 before day 14: end od treatment, if DRS R-98 severity \< 10 during 2 consecutive days At day 14, if DRS R-98 severity ≥ 10: one transdermal patch of Rivastigmine 9.5 mg/24h per day from day 14 to day 30 if DRS R-98 severity \< 10, the active treatment will be stopped |
| placebo patch | DRUG | One transdermal patch of placebo per day from randomization to day 14 Before day 14: end of treatment if DRS R-98 severity \< 10 during 2 consecutive days, At day 14 if DRS R-98 severity ≥ 10: One transdermal patch of placebo per day from day 14 to day 30 if DRS R-98 severity \< 10, the placebo treatment will be stopped |
Inclusion Criteria: * Patients aged 75 and over * Hospitalization for delirium not correlated to surgery for less than 48 hours * Patients with delirium requiring the presence of features 1 (acute onset and fluctuation course), 2 (inattention), 3 (disorganized thinking) and 4 (altered level of cons...