Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2009-015632-15 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to evaluate the efficacy of an anticholinesterase treatment in patients aged 75 and over, hospitalized with delirium.
Study type : Interventional Study design: randomized, double-blind, placebo-controlled study during one month and a 11-month follow-up
Delirium affects up to 50% of hospitalized patients aged 75 and over. Delirium increases risk of comorbid illness, hospital length of stay, institutionalization, and death. Patients with diagnosed or undiagnosed cognitive impairment are at risk to develop delirium. In a prospective study, half of elderly patients with delirium seen in the emergency department had cognitive impairment.
Hypothesis: cholinesterase inhibitors reduce duration and severity of delirium
Main objective:
- to assess the efficacy of cholinesterase inhibitors in patients aged 75 and over hospitalized with delirium
Secondary objectives:
Evaluation of the delirium severity will be conducted with DRS-R98 severity each day during the hospitalization.
At day 14, according to DRS-R98 severity score, interruption of treatment or upward dose titration At day 30, last treatment (active or placebo) administration and evaluation with CAM, DRS-R98 severity, MMSE and DSM IV dementia criteria. In case of dementia diagnosis, investigator (MD) will identify the etiologic diagnosis.
At month 3 and 12, evaluation with CAM, DRS-R98 severity, MMSE and DSM IV dementia criteria, number of consultation and hospitalization. In case of dementia diagnosis, , investigator (MD) will identify the etiologic diagnosis.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rivastigmine transdermal patch | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital length of stay from randomization to declaration by investigator (MD) that patient can leave acute care | to a maximum of 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with persistent delirium symptoms (DRS R-98 scale) | at day 14 | |
| Percentage of patients with persistent delirium symptoms (DRS R-98 scale) | at day 30 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marc Verny, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pitié Salpetriere Hospital | Paris | 75013 | France |
Not provided
| ID | Term |
|---|---|
| D003693 | Delirium |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
|
| Percentage of patients with persistent delirium symptoms at day 30 (CAM scale) |
| at day 30 |
| Percentage of patients with a dementia diagnosis at 12 months (according to the DSM IV criteria) | at 12 months |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |